Cognitive Training With Head-Mounted Display Virtual Reality in Neurorehabilitation: Pilot Randomized Controlled Trial

Background Neurological rehabilitation is technologically evolving rapidly, resulting in new treatments for patients. Stroke, one of the most prevalent conditions in neurorehabilitation, has been a particular focus in recent years. However, patients often need help with physical and cognitive constraints, whereby the cognitive domain in neurorehabilitation does not technologically exploit existing potential. Usually, cognitive rehabilitation is performed with pen and paper or on a computer, which leads to limitations in preparation for activities of daily living. Technologies such as virtual reality (VR) can bridge this gap. Objective This pilot study investigated the use of immersive VR in cognitive rehabilitation for patients undergoing inpatient neurorehabilitation. The goal was to determine the difference in rehabilitation effectiveness between a VR serious game that combines everyday activities with cognitive paradigms and conventional computerized cognitive training. We hypothesized the superiority of the VR serious game regarding cognitive abilities and patient-reported outcomes as well as transfer to daily life. Methods We recruited 42 patients with acute brain affection from a German neurorehabilitation clinic in inpatient care with a Mini Mental Status Test score >20 to participate in this randomized controlled trial. Participants were randomly assigned to 2 groups, with 1 receiving the experimental VR treatment (n=21). VR training consisted of daily life scenarios, for example, in a kitchen, focusing on treating executive functions such as planning and problem-solving. The control group (n=21) received conventional computerized cognitive training. Each participant received a minimum of 18 treatment sessions in their respective group. Patients were tested for cognitive status, subjective health, and quality of life before and after the intervention (Alters-Konzentrations-Test, Wechsler Memory Scale—Revised, Trail Making Test A and B, Tower of London—German version, Short Form 36, European Quality of Life 5 Dimensions visual analog scale, and Fragebogen zur Erfassung der Performance in VR). Results Repeated-measures ANOVA revealed several significant main effects in the cognitive tests: Tower of London—German version (P=.046), Trail Making Test A (P=.01), and Wechsler Memory Scale—Revised (P=.006). However, post hoc tests revealed that the VR group showed significant improvement in the planning, executive control, and problem-solving domains (P=.046, Bonferroni P=.02). In contrast, no significant improvement in the control group between t0 and t1 was detected (all P>.05). Furthermore, a nonsignificant trend was observed in visual speed in the VR group (P=.09, Bonferroni P=.02). Conclusions The results of this pilot randomized controlled trial showed that immersive VR training in cognitive rehabilitation had greater effectiveness than the standard of care in treating patients experiencing stroke in some cognitive domains . These findings support the further use and study of VR training incorporating activities of daily living in other neurological disorders involving cognitive dysfunction. Trial Registration Federal Registry of Clinical Trials of Germany (DRKS) DRKS00023605; https://drks.de/search/de/trial/DRKS00023605

Is this a full powered effectiveness trial or a pilot/feasibility trial? * Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR)

1a-i) Identify the mode of delivery in the title
Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if o ine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms. Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Head-mounted display "virtual reality" cognitive training in neurorehabilitation: Randomized controlled pilot study

1a-ii) Non-web-based components or important co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
A u s w a h l l ö s c h e n Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Meine Antwort Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Head-mounted display virtual reality cognitive training in "neurorehabilitation": Randomized controlled pilot study 29.06.23, 18:01 CONSORT-EHEALTH (V 1.6.1) - subitem not at all important 1 2 3 4 5 essential 1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) A u s w a h l l ö s c h e n Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants were randomly assigned to two groups, one receiving the experimental VR treatment (N=21). The VR training consists of daily life scenarios, e.g., a kitchen, focusing on treating executive functions like planning and problem-solving. The control group (N=21) received conventional computerized cognitive training." subitem not at all important 1 2 3 4 5 essential 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) A u s w a h l l ö s c h e n Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Meine Antwort subitem not at all important 1 2 3 4 5 essential 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional o ine trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) A u s w a h l l ö s c h e n Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "We recruited 42 patients with acute brain affection from a German neurorehabilitation clinic in inpatient care with MMST>20 to participate in this RCT." Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The VR group received treatment with an early version of teora mind, conceptualized and developed by the medical device manufacturer living brain (Heidelberg, Germany), a cognitive training in immersive virtual reality (VRCT). teora mind is a certified medical device of risk class IIa according to the Medical Device Regulation (EU) 2017/745. The certification procedure was executed by the Notified Body TÜV Süd in 2021. The SG integrates ADL and cognitive training methods in a playful way to improve cognition and transfer into daily life and consists of realistic scenarios for training specific abilities. Subjects were trained in a virtual garden and kitchen scenario. In the kitchen, patients were asked to make coffee for multiple people. Therefore, they had to actively implement all necessary steps for serving coffee, including filling the coffee machine with beans and water, changing the coffee filter, choosing a mug, and considering if the coffee has to be served with milk and sugar. Other exercises included sorting groceries according to their categories, e.g., beverages, fruits and vegetables, and durable food for stock, or sorting out the refrigerator according to specifications like spoiled food. A time pressure component was added with increasing difficulty. All activities were implemented in real-time and through patient interaction with the virtual environment." "The control group received the CCT used in routine care at the rehabilitation center at least three times a week for 30 minutes each session, in this case, Freshminder. Freshminder is a cognitive training program with multiple training paradigms, focusing on attention, planning, and memory. The training is conducted on a PC with a keyboard and a mouse. Users must interact with the application by clicking objects or deciding by pressing a key on the keyboard. In this study, the following tasks were considered: pearlfish (vigilance, working memory), picture series (memory), step sequence (action planning), task switching (flexibility), and double play (divided attention). For example, in the pearlfish task, subjects had to click on fish that carry pearls with them. Subjects had to discriminate which fish were holding pearls and identify the fish at the correct time so that the pearl fell appropriately into the box at the bottom of the sea. This exercise trains selective attention, visual perception, and visuomotor skills. All exercises could be adapted to the patient's performance by changing difficulty and level at the beginning of each task. This was adapted by the therapist in charge. Patients received information about their performance in the training tasks. They could choose from a subset of exercises, with the therapist ensuring that all exercises were performed at a well-balanced frequency." Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Instead, customized virtual reality (VR) training is suitable for multi-domain ADL training [13,14]. VR is defined as images and sounds created by a computer that seems almost indistinguishable from the real world and can be interacted with by users with sensors [15]. Although it can be experienced nowadays with purpose-made head-mounted displays (HMD) placed on the head in front of the eyes for a fully immersive experience, the interaction with a virtual world is mainly carried out with two hand controllers. VR enables the combination of principles from occupational therapy, neuropsychology, and ADL, resulting in an ecologically valid training setting for many individuals with neurological impairments who want to regain their ability to participate in daily activities. While insights exist concerning the acceptance of immersive HMD-VR in stroke patients [16] or older adults [17], the knowledge about the processes of cognitive rehabilitation facilitated by immersive VR needs to be expanded." One concept that is becoming more widespread in neurorehabilitation is serious games ( Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study • The primary objective is to assess the impact of an ADL-based VR-SG on patients' cognitive abilities after acute brain affection throughout a 4-week treatment and compared to a conventional CCT treatment. • The secondary objective is assessing the impact of an ADL-based VR-SG on selfreported outcomes, quality of life, state of health, affect, and compared to a conventional CCT treatment. • The tertiary objective is to assess the impact of an ADL-based VR-SG on the actual transfer of learned abilities in VR to daily life and reality compared to a conventional CCT treatment. • The exploratory objective was to investigate the extent to which an ADL-based VR-SG is suitable for cognitive rehabilitation from phase C onwards.
Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The trial was planned with a parallel design." Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The item is not relevant, as there haven't been changes to methods after trial commencement. If there haven't been changes this has not to be explicitly reported.

3b-i) Bug fixes, Downtimes, Content Changes
Bug xes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc.
Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The item is not relevant, as there haven't been changes to methods after trial commencement. No significant changes to the used software were made while trial conduction. If there haven't been changes this has not to be explicitly reported. Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "A phase C status qualified patients to participate in the clinical trial, and transition to phase D during study participation was possible. No patient started earlier or later than phase C. All participants were required to be legally competent and of age and had to undergo inpatient neurological rehabilitation treatment at the neurorehabilitation clinic due to acute brain affection (e.g., cerebral infarction, intracerebral hemorrhage, subarachnoid hemorrhage, subdural or epidural intracranial hemorrhage, traumatic brain injury, brain tumor, meningitis or encephalitis, hypoxic encephalopathy), had to have full functionality for at least one arm, known adequate or corrected eyesight in the central field of vision and had to give written consent to participate. Patients were also screened for cognitive performance using the MMST [29]. The obtained score had to be >20 out of 30. The cutoff value was chosen as some cognitive impairment is expected in this sample, and scores of 27-30 (no cognitive impairment) would not properly represent the sample of patients undergoing neurorehabilitation. Patients were excluded if they had present or prior psychiatric comorbidities/disorders and known overreaction to visual stimulation leading to seizures"

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We don't clarify this criterion explicitly, as we introduce a completely new technology to a group of patients that is not in itself familiar with the internet or similar technologies. Therefore we didn't make it a basic requirement.
4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con rmation, phone calls) were used to detect/prevent these. Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants were screened and recruited for enrollment at the Asklepios Neurologische Klinik Falkenstein clinic in Königstein im Taunus, Germany." "The admission interview at the rehabilitation clinic and the patient records of newly admitted rehabilitation patients were used to recruit the sample. A phase C status qualified patients to participate in the clinical trial, and transition to phase D during study participation was possible. No patient started earlier or later than phase C."

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results. Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Once patients eligible for the study had been identified, they were targeted by trained study personnel and informed of the opportunity to participate. In this course, the contents and objectives of the study were explained." -Patients received a form that informed about the whole trial and its targets.
Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants were screened and recruited for enrollment at the Asklepios Neurologische Klinik Falkenstein clinic in Königstein im Taunus, Germany."

4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise. 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict of interest" section or mentioned elsewhere in the manuscript).
Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "This work was partially funded by the medical device manufacturer living brain GmbH, Heidelberg, DE, who developed the used VR software. The co-authors of this publication, Barbara Stegmann and Julian Specht are the co-founders of living brain." subitem not at all important 1 2 3 4 5 essential 5-ii) Describe the history/development process Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Overall, acceptance and usability of both technologies were reportedly observable high, which is concerning the VR experience congruent to the results of our feasibility study with an earlier version of the software used in this trial [16]."

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study In the trial, an early, specifically for this clinical trial, prepared version has been used. At that time, the medical device had not been introduced to the market. It was updated two times in the course of the trial for minor bugs.
subitem not at all important 1 2 3 4 5 essential 5-iv) Quality assurance methods Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Meine Antwort subitem not at all important 1 2 3 4 5 essential 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.
Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Pictures of the applications used in this trial are available in the appendix and the methods section.

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As the applications used in this trial are commercialized, it's impossible to archive the source code so that other researchers can use it.

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci c group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The trial compares two treatments: a novel immersive VR intervention to treat cognitive dysfunction, specifically EF, presenting ADL in the form of an SG, and conventional computerized cognitive rehabilitation training in inpatient care at a German rehabilitation hospital." "All participants were required to be legally competent and of age and had to undergo inpatient neurological rehabilitation treatment at the neurorehabilitation clinic due to acute brain affection (e.g., cerebral infarction,...)" By the nature of the patient group (patients in inpatient neurological rehabilitation), their only access to the solutions was by staying at the hospital. Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The VR group received treatment with an early version of teora mind, conceptualized and developed by the medical device manufacturer living brain (Heidelberg, Germany), a cognitive training in immersive virtual reality (VRCT). teora mind is a certified medical device of risk class IIa according to the Medical Device Regulation (EU) 2017/745. The certification procedure was executed by the Notified Body TÜV Süd in 2021. The SG integrates ADL and cognitive training methods in a playful way to improve cognition and transfer into daily life and consists of realistic scenarios for training specific abilities. Subjects were trained in a virtual garden and kitchen scenario. In the kitchen, patients were asked to make coffee for multiple people. Therefore, they had to actively implement all necessary steps for serving coffee, including filling the coffee machine with beans and water, changing the coffee filter, choosing a mug, and considering if the coffee has to be served with milk and sugar. Other exercises included sorting groceries according to their categories, e.g., beverages, fruits and vegetables, and durable food for stock, or sorting out the refrigerator according to specifications like spoiled food. A time pressure component was added with increasing difficulty. All activities were implemented in real-time and through patient interaction with the virtual environment. In the garden scenario, patients were asked to plant seeds for growing strawberries, tomatoes, and cucumbers. In the growth phase, users had to ensure that there was always enough water in the bed and that popping weeds did not destroy the seedlings, which required watering the bed with a watering can. After successfully growing fruits and vegetables, users could produce juices from the harvested food. Subjects had to plan their activity by first sorting picture cards describing each action step on a board in what they thought was the correct order. Next, they had to confirm the order. Finally, the system reported whether the order was correct or incorrect and indicated which steps were arranged incorrectly. Only after the right order was achieved, the exercise could begin. The complexity varied depending on the difficulty level; at the highest level, planning was omitted, and the activity had to be started immediately.
The main cognitive domains targeted by the VR training are EFs, thereof action planning, problem-solving, selective attention, and working memory. The specific pieces of training themselves do not primarily focus on a single cognitive domain but rather on training the ADL, which typically comprises multiple cognitive domains simultaneously. Like the CCT intervention, the difficulty could be adapted to the individual performance by changing to 20 different degrees of difficulty. The therapist in charge adapted this. The patients received information in the VR application about how they performed their training tasks. In the trial, an early, specifically for this clinical trial, prepared version has been used. At that time, the medical device had not been introduced to the market. It was updated two times in the course of the trial for minor bugs.
VR devices of the brand Oculus® Quest (Meta) were used for trial conduction. The device is a standalone HMD, further technical devices for experiencing immersive VR are not required. In addition to the VR device, the study nurses and therapists in charge received a tablet (Samsung® Galaxy Tab A) for monitoring ongoing VR activities; all VR procedures were mirrored on the tablet in real time. This allowed patient-therapist interaction despite the high grade of immersion and was particularly in the first training sessions of benefit. Interaction in immersive VR was enabled by hand controllers patients used. Blue hands visually represented them and were congruent with the actual movement of the upper extremities. The controllers included multiple buttons, of which only two were necessary for using this VR software. Moving the head made it possible to gain a complete overview of the virtual world. Through a visible white beam, users could assess what they were currently pointing at in the virtual environment. This allowed the selection of objects. To introduce patients to the technology and the virtual environment, they went through a dedicated tutorial at the beginning of each treatment."

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The treatment was scheduled for 18-25 sessions with a duration of 30 minutes for the individual, based on the date of admission and the participant's immediate health and neurological condition. The sessions were conducted at least three to five days a week. Both groups received their allocated treatment from day 3 to at least day 20. A maximum of 25 treatment sessions was allowed." "Participants in this trial received a treatment dosage of 18.7 sessions over 4-6 weeks, each lasting 30 minutes (9.35h per participant). Other trials reported an average intervention duration of 13.3 hours [40,48,49,50,51,52], ranging from 4 to 24 hours, with a session duration of 30 to 60 minutes, 3 to 5 times a week. Our dosing was sufficient to achieve a measurable effect in some domains and was also oriented on the care reality in German rehabilitation hospitals.

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
A u s w a h l l ö s c h e n

Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The study nurse instructed the intervention group on the device's functions and use before the first VR training session." "During all training sessions, the study nurse was able to track the process on a tablet and was thus able to provide accurate, customized assistance if needed."

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
A u s w a h l l ö s c h e n Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No prompts or reminders were used. It was not relevant as the software was used in attendance of a study nurse. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The study nurse instructed the intervention group on the device's functions and use before the first VR training session. This included the general operation of the device from the outside with the attached buttons (on-off button, volume control), but especially the handling of the hand controllers. After receiving the instructions, participants went through a VR tutorial, consisting of training in basic functionality, the memory game, and the recycling game, in which they were familiarized with general handling in the first training session. This tutorial demonstrated the interaction with the VR environment, virtual objects, and handling the whole experience. The tutorial was developed and tested with stroke patients, leading to high acceptance in a group of stroke patients and healthy older adults, indicating that it's suited for introducing this critical user group to immersive VR [16]. In addition, the familiarization phase helps to reduce possible effects due to unawareness about the technology and negative attitudes towards it [30]. During all training sessions, the study nurse was able to track the process on a tablet and was thus able to provide accurate, customized assistance if needed. 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study • The primary objective is to assess the impact of an ADL-based VR-SG on patients' cognitive abilities after acute brain affection throughout a 4-week treatment and compared to a conventional CCT treatment. • The secondary objective is assessing the impact of an ADL-based VR-SG on selfreported outcomes, quality of life, state of health, affect, and compared to a conventional CCT treatment. • The tertiary objective is to assess the impact of an ADL-based VR-SG on the actual transfer of learned abilities in VR to daily life and reality compared to a conventional CCT treatment. • The exploratory objective was to investigate the extent to which an ADL-based VR-SG is suitable for cognitive rehabilitation from phase C onwards.
subitem not at all important 1 2 3 4 5 essential 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed  [40,48,49,50,51,52], ranging from 4 to 24 hours, with a session duration of 30 to 60 minutes, 3 to 5 times a week. Our dosing was sufficient to achieve a measurable effect in some domains and was also oriented on the care reality in German rehabilitation hospitals. For attaining more significant outcomes in multiple domains, it would be interesting to see if other training tasks in immersive VR create an effect on cognition and if a varying number of treatment sessions beyond inpatient care leads to different results than those reported here. Based on the results of this trial, we conclude that 18-19 sessions à 30 minutes are sufficient to achieve a measurable treatment effect. Still, we cannot answer whether fewer sessions would create similar effects, if more treatment automatically leads to more significant outcomes, and if those effects vary between patient groups. More extensive trials with blinding, subgroups, and longer treatment duration are necessary to answer this question.
subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text

Meine Antwort
Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No changes to these objectives were made after trial commencement. Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Meine Antwort Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No interim analyses have been performed, and no interim analyses have been planned before the trial start.
Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The process of participant randomization is described in the flowchart prepared according to the CONSORT guidelines, we used an analogue randomization process. Simple randomization was done by the study nurse.
Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The process of participant randomization is described in the flowchart prepared according to the CONSORT guidelines, we used an analog randomization process by drawing notes from an urn. Simple randomization was done by the study nurse. 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The process of participant randomization is described in the flowchart prepared according to the CONSORT guidelines, we used an analog randomization process by drawing notes from an urn Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Simple randomization was done by the study nurse. subitem not at all important 1 2 3 4 5 essential 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering cointerventions (if any).
Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The trial was not blinded.

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Meine Antwort 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The differences on the interventions became clear when the study nurse introduced participants to the allocated interventions. Also were patients often on the same stations and had the chance to discuss the treatment they currently experience. The treatments are described in the methods section.
Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Statistical analyses were run on IBM SPSS 29, considering P<.05 as significant. We calculated repeated measures ANOVA and posthoc tests to detect inner-subject and between-group changes between t0 and t1. Comparing the VR group and control group in cognitive performance and health-related measures involves group mean comparisons from two independent samples. Power calculations (power analysis tool GPower, release 3.1.9.6 for Mac OS X) revealed that our sample size of N=21 per group was sufficient to detect a standardized estimated population mean difference of f=.25, which is considered a medium effect size, with a power of 1-β=.88 for α=.05. This shows that our small sample size does not constrain detection of betweengroup effects at a conventional power goal of .8 with a medium effect size of f=.25. subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Only a very few items were missing, so no imputation techniques were needed to apply.
"Of the patients who completed the study, 41 out of 42 participants (97%) completed all questionnaires and tests, with only occasional missing items or tests. This might be explained by the fact that all surveys were conducted in the attendance of a therapist or neuropsychologist working and trained in the clinic." Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No subgroup or adjusted analyses were conducted, so there is no section about these topics. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem X26-i?

X26-i) Comment on ethics committee approval
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Approval for this pilot trial was obtained through the local Ethics Committee of the Regional Medical Association Hessen, Germany, under the approval number 2020-1768-fMP. The VRtraining teora mind is a certified medical device (class IIa) in line with the European medical device regulation MDR and therefore obtained approval to conduct this trial from the state authority Bundesinstitut für Arzneimittel und Medizinprodukte under the file number 94208-5660-12543. All regulatory approvals were obtained before the recruitment of the first patient."

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained o ine or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.

Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Meine Antwort

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline)

Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "To introduce patients to the technology and the virtual environment, they went through a dedicated tutorial at the beginning of each treatment. " 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Twenty-one patients received the novel VR treatment, the other 21 received the control CCT." Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "However, 31 were not able to complete the minimum treatment number due to the following reasons: COVID (4), early dismissal (12), psychiatric comorbidities not detected earlier (3), treatment discontinuation due to a high incidence of COVID cases at the trial center (12)." Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other gures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

Meine Antwort
Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The recruitment process started on November 1st 2020, the last patient finished treatment on March 31st 2022." 14b) Why the trial ended or was stopped (early) 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

Meine Antwort
Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "A further extension of the trial was not possible for administrative reasons."

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known. Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Since this study refers to a defined target group and participation is not from the total population and additionally takes place in a closed setting (hospital), this item is not applicable.

16-i) Report multiple "denominators" and provide definitions
Report multiple "denominators" and provide de nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention. Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "...revealed that our sample size of N=21 per group was sufficient to detect a standardized estimated population mean difference of f=.25, which is considered a medium effect size, with a power of 1-β=.88 for α=.05. This shows that our small sample size does not constrain detection of between-group effects at a conventional power goal of .8 with a medium effect size of f=.25."

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).

Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Meine Antwort 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study All results are demonstrated in Table 4.

17a-i) Presentation of process outcomes such as metrics of use and intensity of use
In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de ned (e.g., timeout after idle time) [1] (report under item 6a).
17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

Meine Antwort
Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This section is not applicable, as there are no binary outcomes, the outcomes of this trial are multi-faceted, and therefore a relative effect size is not described.
Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study There are no other analyses besides those described in the study rationale.

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).

Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Meine Antwort subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Of the 21 patients in the VR group, no subject reported problems with motion sickness or associated nausea; also, no treatment had to be stopped due to motion sickness or nausea. This is congruent with the results of our feasibility trial with stroke patients and healthy older adults, where we demonstrated that applying specific principles in VR development, e.g., having complete control of all motion in VR, reduces the risk of suffering motion sickness and is feasible for use in special needs groups like stroke patients [16]. Patients in the control group, using CCT, reported no negative side effects as well. Patients conducted, on average, 18.7 successful treatment sessions."

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2]. 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study For a distinct description of subitem 22-i see chapter Discussion which includes all required items.

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.
Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Although this study provides valuable insights into the impact of immersive VR on cognitive rehabilitation, many questions remain unanswered. Specifically, we identified the following limitations that should be considered: Future research in this field should be conducted with larger sample groups. This randomized controlled pilot study builds a profound understanding of the potential immersive VR can have in neurological rehabilitation for cognitive impairment in patients with MMST>20, affected by stroke, to the largest extent. Conclusions cannot be drawn to patients below this cutoff score. We also need more information on the manifestation of training effects, e.g., if the measured results are still the same 6-12 months after the intervention and if an actual transfer effect to ADLs occurs. Long-term studies with follow-ups of multiple years are necessary. The applied VR environment was limited to only two training scenarios inspired by ADLs. More training scenarios replicating other ADLs should be developed and tested for future research. Even though there are findings about the application of VR in rehabilitation in other patient groups, e.g., multiple sclerosis, psychiatric disorders, and pain management [53], the hereused application has chiefly been tested in the rehabilitation of patients with acute brain affection. Therefore, the evaluation needs to consider patients from the abovementioned groups to draw further conclusions in other patient groups." 21) Generalisability (external validity, applicability) of the trial findings NPT: External validity of the trial ndings according to the intervention, comparators, patients, and care providers or centers involved in the trial subitem not at all important 1 2 3 4 5 essential

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Meine Antwort Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other cointerventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.

Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Meine Antwort 29.06.23, 18:01 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q… 73/77 24) Where the full trial protocol can be accessed, if available 25) Sources of funding and other support (such as supply of drugs), role of funders Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The trial was registered at the federal register for clinical trials in Germany DRKS under the file number DRKS000023605 and at the central European register for clinical research with medical devices EUDAMED in line with the medical device regulation MDR under the file number CIV-20-06-033349." Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The protocol is deposited in the German Register of Clinical Trials.
Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The Federal State of Baden-Württemberg supported this work through the Innovationsgutschein BW High-Tech Startup funding program." "The co-authors of this publication, Barbara Stegmann and Julian Specht are the cofounders of living brain."

X27) Conflicts of Interest (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential About the CONSORT EHEALTH checklist X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests ( nancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.

Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Meine Antwort As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist?
I added minor things to the manuscript.
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * I spent about 5 hours going through the checklist and making changes to the manuscript As a result of using this checklist, do you think your manuscript has improved? * Would you like to become involved in the CONSORT EHEALTH group? This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document STOP -Save this form as PDF before you click submit To generate a record that you lled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
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