Effectiveness of sensory stimulation and early mobility on consciousness, mental state, RLA stage, and hospital stay in patients with Traumatic brain injury: A research protocol

Devyani Purushe; Moh’d Irshad Qureshi; Raghumahanti Raghuveer

doi:10.12688/f1000research.142211.1

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Study Protocol

Effectiveness of sensory stimulation and early mobility on consciousness, mental state, RLA stage, and hospital stay in patients with Traumatic brain injury: A research protocol

[version 1; peer review: 1 not approved]

Devyani Purushe ¹, Moh’d Irshad Qureshi¹, Raghumahanti Raghuveer¹

PUBLISHED 31 Oct 2023

Author details Author details

¹ Neuro physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India

Devyani Purushe
Roles: Conceptualization, Resources, Writing – Review & Editing

Moh’d Irshad Qureshi
Roles: Conceptualization, Supervision, Validation, Writing – Review & Editing

Raghumahanti Raghuveer
Roles: Conceptualization, Resources, Supervision, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

TBI is the most difficult to treat and has the highest mortality and morbidity rates in ICU. The most common cause of neurological abnormalities and physical disabilities in people is traumatic brain injury (TBI). Brain injury occurs when an external force causes a change in brain function or other signs of brain pathology. TBI is a leading cause of epilepsy and is linked to a high morbidity and mortality rate. Over the last few decades, India has seen an increase in traumatic brain injury (TBI) as a result of increased transportation development, a rapidly growing construction industry, and urbanization. A total of 30 patients with traumatic brain injuries will be included in this experimental study, and they will be evenly divided into two groups. Sensory stimulation with early mobility will be delivered to Group A, while traditional physiotherapy will be given to Group B for two weeks at 40 minutes per session, two sessions per day, 5 days a week. The Coma Recovery scale, Mini-mental scale examination (MMSE), Glasgow Coma Scale (GCS), Ranchos Los Amigos scale for cognitive functioning, and length of stay in ICU will be used as outcome measures. The goal of this study is to see how early mobility exercises and sensory stimulation affect consciousness, mental state, RLA, and hospital stay when used in conjunction with physiotherapy.

CTRI Reference Number

CTRI/2022/07/044127

Keywords

Sensory stimulation, Consciousness, Mental state, RLA, Traumatic Brain Injury, Research Protocol.

Corresponding author: Devyani Purushe

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2023 Purushe D et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Purushe D, Qureshi MI and Raghuveer R. Effectiveness of sensory stimulation and early mobility on consciousness, mental state, RLA stage, and hospital stay in patients with Traumatic brain injury: A research protocol [version 1; peer review: 1 not approved]. F1000Research 2023, 12:1427 (https://doi.org/10.12688/f1000research.142211.1) First published: 31 Oct 2023, 12:1427 (https://doi.org/10.12688/f1000research.142211.1) Latest published: 31 Oct 2023, 12:1427 (https://doi.org/10.12688/f1000research.142211.1)

Introduction

The most common causes of neurological anomaly and physical disabilities in persons is traumatic brain injury (TBI). It encompasses both sensory and motor capabilities that have an impact on one's overall quality of life.¹ TBI is the most difficult to treat and has the greatest morbidity and fatality rates in intensive care units.¹ TBI is thought to affect 200 people per 100,000 in wealthy countries each year.² The country's rapid development in transportation, construction, and urbanization in recent decades has resulted in a high risk of traumatic brain injury.³

The most vulnerable to TBI are adolescent/young adults, children (under 25 years old), and the elderly. A severe TBI may occur in one-third of patients, resulting in long-term cognitive and behavioural deficits. In 20% of cases, brain traumas cause a multisystem condition due to related injuries, which might involve complicated neurological deficits, neuroendocrine, and neuro medical issues.³

Transportation network safety improvements, alcohol and drug awareness programs, and regulations requiring the use of safety belts and helmets have all been important prevention strategies.⁴

TBI has been linked to a large number of neuromuscular, cognitive, and behavioural disorders, all of which can impair activity, social involvement, and overall quality of life.⁵ Motor function is often affected in people who have suffered a TBI. Paresis in the upper and lower extremities, as well as decreased coordination, postural control, aberrant tone, and irregular gait, can all be life-long deficits.⁶ Tremor and chorea are examples of abnormal, involuntary movements, but dystonic motions are less prevalent. Patients may also have compromised somatosensory function, depending on where the lesion is located.⁷

The mental process of knowing and using knowledge is referred to as cognition. Arousal, attention, focus, memory, learning, and executive functions are among the many complicated brain processes that make up cognition. People with altered states of awareness are common. Arousal states such as vegetative state, coma, and minimally conscious state are common after severe brain trauma.⁵ Cognitive impairment was the primary contributor to disability in most brain-injured subjects who scored moderate to severe on the GOS.⁸

The Glasgow Coma Scale is frequently used to determine whether a traumatic brain injury is severe, moderate, or mild (GCS). Teasdale and Jennett developed the GCS, which is the most widely used clinical scale for measuring consciousness and the severity of an injury. The GCS is made up of three different types of responses: motor, verbal, and eye-opening. When the individual response scores are added together, the total score ranges from 3 to 15. A chronic injury is defined as one with a score of 8 or less, a serious brain injury as one with a score of 9 to 12, and a light brain injury as one with a score of 13 to 15.⁵

Physical therapy's main purpose is to minimize secondary consequences from the TBI and prolonged bedrest/immobilization, start early mobilization after receiving medical clearance, and start patient and family education. Monitoring vitals and other comorbidities is used to manage respiratory treatment, coma stimulation, and passive/active mobility for patients.¹ So, the goal of the study will be conducted to see how early mobility exercises and sensory stimulation affect awareness, mental state, and RLA staging in traumatic brain injury patients. To identify the impact of early mobility exercises and sensory stimulation on consciousness using physiotherapy intervention and the goal of this study will be to see how helpful physiotherapy maybe for early mobility exercises and sensory stimulation during an ICU stay.

Aims

The goal of the study is to see how early mobility exercises and sensory stimulation affect awareness, mental state, and RLA staging in traumatic brain injury patients.

Objectives

The following are the study's goals:

1) To determine the impact of early mobility exercises and sensory stimulation on consciousness using physiotherapy intervention.
2) This research aims to see how effective physiotherapy intervention on early mobility exercises and sensory stimulation is for mental health.
3) To determine the efficacy of physiotherapy intervention on early mobility exercises and sensory stimulation in patients with RLA stage.
4) The goal of this study is to see how helpful physiotherapy maybe for early mobility exercises and sensory stimulation during an ICU stay.

Protocol

Study setting

Following ethical approval by the Institutional Ethical Committee of the Datta Meghe Institute of Medical Science the Reference number is DMIMS (DU)/IEC/2022/896 and date is 11/04/2022, the study will be carried out in the Intensive Care Unit (ICU) of the Acharya Vinobha Bhave Rural Hospital (AVBRH) in the Sawangi Meghe Wardha.

Study design

It is a two arm parallel interventional study. The total amount of participants in Group A will be 15, while Group B will have 15 (n=30).

Participants

Inclusion criteria: Patients aged 35 to 60 years old with mild to moderate traumatic brain injury with or without craniotomy and a Glasgow Coma Scale (GCS) score of 13.

Exclusion criteria: The patient with a history of visual and Auditory dysfunction (blindness, color blindness, deafness, hearing loss). The Patient with alcohol and drug in toxification with he/she is on anticonvulsants were excluded.

Recruitment procedure

Patients admitted to the Intensive Care Unit with traumatic brain injuries (ICU) at Acharya Vinoba Bhave Rural Hospital and meet the criteria for inclusion will be included in the study. Patients will be randomly allocated into two groups using simple random sampling and will be assigned through sequentially numbered opaque sealed envelopes. The experimental group will receive sensory stimulation and early mobility exercises whereas the control group will receive traditional physiotherapy.

Procedure

Participant timeline

The study will last one year, and the physiotherapy intervention will last 30 minutes per session, two times per day, five days a week for two weeks.

Implementation

The research coordinator and principal investigator will be in charge of randomization. For recruitment into either group, participants will be asked to choose a sealed group allocation from an envelope.

Blinding

To assign the subjects to the groups, the tester(s) will be blinded. Subjects will be required not to reveal any details about their treatment to the tester in order to ensure binding.

Study procedure

Following the ethical committee's approval, the participants will be given a thorough explanation of the technique, and their informed consent will be obtained. The study will include all those who are willing to participate.

The research will be implemented in the ICU setting. The patients will be chosen based on the inclusion criteria listed above. After obtaining signed informed consent from a caregiver or family member, patients who meet the inclusion criteria will be enrolled in this study. Informed consent will be taken by caregiver as the patient will be unaware about the situation. Simple random sampling will be used to assign patients to one of two groups, which will be assigned through sequentially numbered opaque sealed envelopes. The patients’ blood relatives or primary caregiver is the point of contact for randomization and allocation. The experimental group will be receiving Sensory stimulation and early mobility exercises whereas the control group will receive conventional physiotherapy. For two weeks, both groups will receive 30 minutes of instruction per session, two times per day.

Group A – Participants in this group will receive Sensory stimulation with early mobility

40 min a session, two sessions per day, 5 days a week for 2 weeks.

Sensory stimulation

The program of sensory stimulation was divided into five sections:

1. Awakening for 5 Minutes
The position of Therapist and caregiver will be at the side of the patient's bed. The therapist and caregiver will call out the patient's name and give commands for an eye-opening. The patient's response will be noted for the response. If in case, the patient does not open the eyes, wet gauze will be applied to the patient's eyes.
2. Auditory Stimulation for 10 Minutes
The therapist and caregiver first clean the earplugs of the earphones with a spirit swab and then connect the earplugs to the mobile, will put the earplugs in the patient's ears and turn on the Carnatic instrumental theme (Hare Krishna Hare Krishna, Krishna Krishna Hare Hare). It will be given for 10 minutes. If patient will be applied the same musical note repeatedly to get accustomed to the music.
3. Visual Stimulation for 10 Minutes
The physiotherapist will open the patient's right eye with his/her left hand and stimulated it with bright light on/off for 1 second and will repeat it for 10 seconds. The source of light will be a torch held in the therapist’s right hand. After 10 seconds, the same will be repeated for the left eye.
4. Tactile Stimulation for 5 Minutes
Tactile stimulation will be aimed to provide several elements of tactile sense such as touch, pressure, and temperature. The tactile sense of touch will be given with the help of a wisp of cotton, the pressure was given with the use of a comb, and the temperature will be provided with the help of hot and cold packs. This stimulation shall be given to all four limbs of the patient. Each stimulus will be given every 5 seconds. The response will be varied from patient to patient. If patients have difficulty recognizing different types of touch, such as light touch versus deep pressure then repeated tactile stimulation will be given.
5. Olfactory Stimulation for 10 Seconds
The therapist or caregiver, first, will clean each nostril with the earbuds. Then one nostril will be closed with the thumb, and the coffee or camphor or spices will be kept near the opposite nostril of the patient, so that the patient could smell and the same will be repeated in the other nostril. Herbs such as cloves will be used with the help of cotton for 10 seconds. The stimulus which will be used placed 3 cm from the nostrils. It will be given for 10 seconds after every 15 seconds. If the patient will be having difficulty perceiving the distinct aroma of coffee and the strong scent of camphor or the fragrance of clove, then repeated olfactory stimulation will be given.⁹

Early mobility: Early mobility is described as starting the mobility program when the patient can participate in therapy minimally, has a stable hemodynamic status, and is obtaining adequate oxygen levels.

Because it meets parts of therapy goals during the early stages of recovery, upright sitting is particularly significant. The patient should be transported to a sitting posture and out of bed onto a wheelchair as soon as they are medically stable. All safety precautions should be followed. The head should be properly supported because the patient is unlikely to have adequate neck and head control to maintain an upright posture without assistance. Co-treatment with an occupational therapist provides two skilled professionals to assist the patient because maximal assistance is often required. The use of a tilt table is also advantageous because it allows early weight-bearing through the LEs. The upright position, both on a tilt table and in a wheelchair, may improve the overall level of alertness.¹⁰

Group B- subjects in the control group will undergo traditional physiotherapy, which will involve passive limb exercises as well as an in-bed posture to avoid pressure sores. The treatment would last 40 minutes.

Pre and post outcome measures will be taken by utilizing the Coma Recovery Scale (CRS), Mini-mental scale examination (MMSE), Glasgow Coma Scale (GCS), and Ranchos Los amigos scale parameters by the assessor who will be aware of the outcome measures and having a similar experience that of the Physiotherapy resident doing the study. The assessor will be blinded for the treatment.

Outcome measures

Coma Recovery Scale (CRS)

The Revised JFK Coma Recovery Scale (CRS-R) is a tool for assessing patients who will be in a level of awareness such as coma. It can help distinguish the vegetative state (VS) from the minimally conscious state (MCS). It will also be used to track the transition from a semi-conscious to conscious state.

Reliability: 0.94

Validity: 0.97¹¹

Mini-mental scale examination (MMSE)

The Mini-Mental State Examination (MMSE) is a reliable and effective tool for determining whether or not an older person has cognitive impairment. By including detailed administration and scoring criteria, the original instrument's reliability was improved (the Standardized MMSE [SMMSE]). The SMMSE is a thorough assessment tool for seniors. It generates a global score of cognitive capacity that is linked to daily task performance.

Reliability: 0.80-0.95

Glasgow Coma Scale (GCS)

The Glasgow Coma Scale is used to categorize traumatic brain damage as severe, moderate, or mild (GCS). The GCS was created by Teasdale and Jennett and is the most extensively used clinical scale for evaluating consciousness and helps in the characterization and classification of injury severity. The GCS is composed of three reaction scores: verbal response, motor response, and eye-opening. The sum of the individual activity scores yields a total score ranging from 3 to 15. A score of 8 or less indicates severe brain injury, a score of 9 to 12 indicates serious brain injury, and a score of 13 to 15 indicates mild brain injury.¹²

Reliability- 0.86

Ranchos Los amigos scale for cognitive functioning

Acute care professionals also use the Rancho Los Amigos Scale (RLA) (Hagen, 1984) to classify a patient's condition as well as decide discharge placement. It is divided into ten degrees of cognitive functioning:

No response, generalized response, localized response, confused agitated, confused-inappropriate, confused-appropriate, automatic-appropriate, purposeful-appropriate, Purposeful, Appropriate: Stand by Assistance and Purposeful, Appropriate: Stand by Assistance on request.⁵

Reliability- 0.87

Validity- 0.92

The subject shall be examined immediately after the coma stimulation and the scoring shall be done for GCS, CRS, MMSE, and RLA scales. The scoring shall be done on the 0^th day and after 15 days.

Sample size Calculation: Daniel formula for sample size (1999).

n = {(Z α / 2)}^{2} * P * (1 - P) / d^{2}

where;

Zα/2 is the level of significance at 5% i.e., 95% Confidence interval= 1.96

P = Prevalence of TBI= 0.97% = 0.0097

D = Desired error of margin= 5% = 0.05

n = {1.96}^{2} \times 0.097 \times (1 - 0.097) \div {0.05}^{2} = 14.76

= 15 patients needed in each group

Study Reference article

As per this article G. Gururaj et alEpidemiology of traumatic brain injuries: Indian scenario. The prevalence of TBI is p value = 0.0097.¹³

Analysis

Results over the outcome variables will be tabulated and described using descriptive statistics; data over the outcome variables will be tested for normal distribution for the mean and standard deviation (SD) mean statistics will be positioned for finding skewed distributions and interquartile range (IQR). Frequency and percentages for binary and categorical variables will be tabulated for descriptive statistics. SPSS 27.0 software will be used for all statistical analysis.

Dissemination

We are planning to publish in an Indexed journal.

Study status

The Recruitment of participants has been done.

Discussion

The goal of the protocol will be conducted to see how sensory stimulation and early mobility affect patients with traumatic brain injury's consciousness, mental state, RLA stage, and hospital stay. This sensory stimulation is broken down into five sections: Five minutes of awakening, ten minutes of visual stimulation ten minutes of auditory stimulation, and five minutes of tactile stimulation and olfactory stimulation for ten seconds, with early mobility exercises in between. This will be given to one group and for other group we will give passive limb exercises as well as an in-bed posture to avoid pressure sores.

Conclusion

This study will show effectiveness of early mobility exercises and sensory stimulation on the level of consciousness, mental state, RLA stage and ICU stay in individuals with traumatic brain injury.

Acknowledgements

I would like to acknowledge Mr. Laxmikant Umate Sir, who has helped me in sample size calculation and data analysis planning.

References

1. Thomas A, Shravani B, Poulose L, et al.: Early Mobilisation Improves Conscious Levels, Cognitive Levels and Reduction in Number of Days in Intensive Care Unit Stay in Moderate to Severe Traumatic Brain Injury Patients-A Hospital Based Study.2018 Mar 1.
2. Bruns J, Hauser WA: The Epidemiology of Traumatic Brain Injury: A Review: EPIDEMIOLOGY OF TRAUMATIC BRAIN INJURY. Epilepsia. 2003 Sep 26; 44: 2–10. Publisher Full Text
3. Panwar N, Purohit D, Deo Sinha V, et al.: Evaluation of extent and pattern of neurocognitive functions in mild and moderate traumatic brain injury patients by using Montreal Cognitive Assessment (MoCA) score as a screening tool: An observational study from India. Asian J. Psychiatr. 2019 Mar; 41: 60–65. PubMed Abstract | Publisher Full Text
4. Borg J, Röe C, Nordenbo A, et al.: Trends and Challenges in the Early Rehabilitation of Patients with Traumatic Brain Injury: A Scandinavian Perspective. Am. J. Phys. Med. Rehabil. 2011 Jan; 90(1): 65–73. PubMed Abstract | Publisher Full Text
5. Chesnut RM, Carney N, Maynard H, et al.: Evidence Report on Rehabilitation of Persons with Traumatic Brain Injury.287.
6. Hellweg S, Johannes S: Physiotherapy after traumatic brain injury: A systematic review of the literature. Brain Inj. 2008 Jan; 22(5): 365–373. Publisher Full Text
7. Chua KS, Ng YS, Yap SG, et al.: A Brief Review of Traumatic Brain Injury Rehabilitation. A Brief Review of Traumatic Brain Injury Rehabilitation. 2007; 36(1): 31–42. Publisher Full Text
8. Hellweg S: Effectiveness of Physiotherapy and Occupational Therapy after Traumatic Brain Injury in the Intensive Care Unit. Crit. Care Res. Prac. 2012; 2012: 1–5. Publisher Full Text
9. Passler MA, Riggs RV: Positive outcomes in traumatic brain injury–vegetative state: Patients treated with bromocriptine. Arch. Phys. Med. Rehabil. 2001 Mar; 82(3): 311–315. PubMed Abstract | Publisher Full Text
10. Zaninotto AL, El-Hagrassy MM, Green JR, et al.: Transcranial direct current stimulation (tDCS) effects on traumatic brain injury (TBI) recovery: A systematic review. Dement Neuropsychol. 2019 Jun; 13(2): 172–179. PubMed Abstract | Publisher Full Text | Free Full Text
11. Lippert-GrÜner M, Wedekind C, Klug N: Outcome of prolonged coma following severe traumatic brain injury. Brain Inj. 2003 Jan; 17(1): 49–54. Publisher Full Text
12. Physiopedia: [cited 2022 Feb 12]. Glasgow Coma Scale.Reference Source
13. Gururaj G: Epidemiology of traumatic brain injuries: Indian scenario. Neurol. Res. 2002 Jan; 24(1): 24–28. PubMed Abstract | Publisher Full Text

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Author details Author details

¹ Neuro physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India

Devyani Purushe
Roles: Conceptualization, Resources, Writing – Review & Editing

Moh’d Irshad Qureshi
Roles: Conceptualization, Supervision, Validation, Writing – Review & Editing

Raghumahanti Raghuveer
Roles: Conceptualization, Resources, Supervision, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

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Published: 31 Oct 2023, 12:1427

https://doi.org/10.12688/f1000research.142211.1

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© 2023 Purushe D et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Purushe D, Qureshi MI and Raghuveer R. Effectiveness of sensory stimulation and early mobility on consciousness, mental state, RLA stage, and hospital stay in patients with Traumatic brain injury: A research protocol [version 1; peer review: 1 not approved] F1000Research 2023, 12:1427 (https://doi.org/10.12688/f1000research.142211.1)

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PUBLISHED 31 Oct 2023

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Reviewer Report 30 Apr 2024

Domenico Intiso, Unit of Neuro-Rehabilitation, IRCCS “Casa Sollievo della Sofferenza”, San Giovanni Rotondo, Italy

Not Approved

https://doi.org/10.5256/f1000research.155731.r264987

The authors proposed a study protocol to investigate the effects of sensory stimulation and early mobilization on the recovery of consciousness, mental state and long of stay of adult traumatic brain injury subjects admitted in ICU. Although the study is ... Continue reading

The authors proposed a study protocol to investigate the effects of sensory stimulation and early mobilization on the recovery of consciousness, mental state and long of stay of adult traumatic brain injury subjects admitted in ICU. Although the study is interesting severe criticisms arise about the protocol and method design.

Background is bare and based on outdated references. Some of them are incomplete (ref. 1 and 5). The choice of early mobilization and sensory stimulation to facilitate the outcome of TBI subjects and particularly the recovery of consciousness is poorly motivated and explained.
The reasons to investigate these rehabilitative intervention are poorly addressed and the introduction is predominantly conceived and organized in relation to one reference.
The authors should highlight the role and the effect of mobilization on the recovery and focus the aim of study based on recent literature data. Indeed, a lot of studies about early mobilization in critically ill patients has been published in particular to prevent muscular weakness (1), but several questions remain unsolved about early mobilization in neurological ICU patients(Bartolo M, et al., 2017[Ref 1]), (Maia TFLD, et al., 2024[Ref 2]).
The authors affirmed that inclusion criteria were: patients aged 35 to 60 years old with mild to moderate traumatic brain injury with or without craniotomy and a Glasgow Coma Scale (GCS) score of 13.
In this respect is not clear the reason to employ CRS as measure. Indeed, this scale is generally used in subjects unresponsive or in coma, but inclusion criteria considered only subjects with moderate or mild TBI or subjects graded to GCS 13. This score generally is observed in awake, responsive patients. The choice of CRS is conflicting and unclear.
Likewise, the use of sensory stimulation in responsive subjects is unclear given that those are awake (GCS 13) and might be conscious, even if confusion and agitation might be observed.
However, the authors described the delivery of sensory stimulation (auditory, visual, tactile, etc.) as if subject was unresponsive. Furthermore is unclear the timing of start the early mobilization.
The authors affirmed that the mobility program start when the patient can participate in therapy minimally, has a stable hemodynamic status, and is obtaining adequate oxygen levels.
The patient should be transported to a sitting posture and out of bed onto a wheelchair as soon as they are medically stable. However, this condition might occur late during ICU stay opposing the early mobilization.
Early or late mobilization is debated. Recent literature show different modality to early mobilization (Huebner L, et al., 2024[Ref 3]). No clinical and neurological variable commonly occurring during ICU stay that can act on the recovery is considered.
Likewise, no previous clinical or neurological disease that can bias the finding has been considered in exclusion criteria.

Is the rationale for, and objectives of, the study clearly described?

No
Is the study design appropriate for the research question?

No
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

References

1. Bartolo M, Bargellesi S, Castioni CA, Intiso D, et al.: Mobilization in early rehabilitation in intensive care unit patients with severe acquired brain injury: An observational study.J Rehabil Med. 2017; 49 (9): 715-722 PubMed Abstract | Publisher Full Text
2. Maia TFLD, Magalhães PAF, Santos DTS, de Brito Gomes JL, et al.: Current Concepts in Early Mobilization of Critically Ill Patients Within the Context of Neurologic Pathology.Neurocrit Care. 2024. PubMed Abstract | Publisher Full Text
3. Huebner L, Warmbein A, Scharf C, Schroeder I, et al.: Effects of robotic-assisted early mobilization versus conventional mobilization in intensive care unit patients: prospective interventional cohort study with retrospective control group analysis.Crit Care. 2024; 28 (1): 112 PubMed Abstract | Publisher Full Text
4. Ruo Yu L, Jia Jia W, Meng Tian W, Tian Cha H, et al.: Optimal timing for early mobilization initiatives in intensive care unit patients: A systematic review and network meta-analysis.Intensive Crit Care Nurs. 2024; 82: 103607 PubMed Abstract | Publisher Full Text

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: severe acquired brain injury, rehabilitation, spasticity, stroke, critical illness polyneuropathy and myopathy

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

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Domenico Intiso, Unit of Neuro-Rehabilitation, IRCCS “Casa Sollievo della Sofferenza”, San Giovanni Rotondo, Italy

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Not Approved

The authors proposed a study protocol to investigate the effects of sensory stimulation and early mobilization on the recovery of consciousness, mental state and long of stay of adult traumatic brain injury subjects admitted in ICU. Although the study is interesting severe criticisms arise about the protocol and method design.

Background is bare and based on outdated references. Some of them are incomplete (ref. 1 and 5). The choice of early mobilization and sensory stimulation to facilitate the outcome of TBI subjects and particularly the recovery of consciousness is poorly motivated and explained.
The reasons to investigate these rehabilitative intervention are poorly addressed and the introduction is predominantly conceived and organized in relation to one reference.
The authors should highlight the role and the effect of mobilization on the recovery and focus the aim of study based on recent literature data. Indeed, a lot of studies about early mobilization in critically ill patients has been published in particular to prevent muscular weakness (1), but several questions remain unsolved about early mobilization in neurological ICU patients(Bartolo M, et al., 2017[Ref 1]), (Maia TFLD, et al., 2024[Ref 2]).
The authors affirmed that inclusion criteria were: patients aged 35 to 60 years old with mild to moderate traumatic brain injury with or without craniotomy and a Glasgow Coma Scale (GCS) score of 13.
In this respect is not clear the reason to employ CRS as measure. Indeed, this scale is generally used in subjects unresponsive or in coma, but inclusion criteria considered only subjects with moderate or mild TBI or subjects graded to GCS 13. This score generally is observed in awake, responsive patients. The choice of CRS is conflicting and unclear.
Likewise, the use of sensory stimulation in responsive subjects is unclear given that those are awake (GCS 13) and might be conscious, even if confusion and agitation might be observed.
However, the authors described the delivery of sensory stimulation (auditory, visual, tactile, etc.) as if subject was unresponsive. Furthermore is unclear the timing of start the early mobilization.
The authors affirmed that the mobility program start when the patient can participate in therapy minimally, has a stable hemodynamic status, and is obtaining adequate oxygen levels.
The patient should be transported to a sitting posture and out of bed onto a wheelchair as soon as they are medically stable. However, this condition might occur late during ICU stay opposing the early mobilization.
Early or late mobilization is debated. Recent literature show different modality to early mobilization (Huebner L, et al., 2024[Ref 3]). No clinical and neurological variable commonly occurring during ICU stay that can act on the recovery is considered.
Likewise, no previous clinical or neurological disease that can bias the finding has been considered in exclusion criteria.

Is the rationale for, and objectives of, the study clearly described?

No
Is the study design appropriate for the research question?

No
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

References

1. Bartolo M, Bargellesi S, Castioni CA, Intiso D, et al.: Mobilization in early rehabilitation in intensive care unit patients with severe acquired brain injury: An observational study.J Rehabil Med. 2017; 49 (9): 715-722 PubMed Abstract | Publisher Full Text
2. Maia TFLD, Magalhães PAF, Santos DTS, de Brito Gomes JL, et al.: Current Concepts in Early Mobilization of Critically Ill Patients Within the Context of Neurologic Pathology.Neurocrit Care. 2024. PubMed Abstract | Publisher Full Text
3. Huebner L, Warmbein A, Scharf C, Schroeder I, et al.: Effects of robotic-assisted early mobilization versus conventional mobilization in intensive care unit patients: prospective interventional cohort study with retrospective control group analysis.Crit Care. 2024; 28 (1): 112 PubMed Abstract | Publisher Full Text
4. Ruo Yu L, Jia Jia W, Meng Tian W, Tian Cha H, et al.: Optimal timing for early mobilization initiatives in intensive care unit patients: A systematic review and network meta-analysis.Intensive Crit Care Nurs. 2024; 82: 103607 PubMed Abstract | Publisher Full Text

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

severe acquired brain injury, rehabilitation, spasticity, stroke, critical illness polyneuropathy and myopathy

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

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Effectiveness of sensory stimulation and early mobility on consciousness, mental state, RLA stage, and hospital stay in patients with Traumatic brain injury: A research protocol

Abstract

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Introduction

Aims

Objectives

Protocol

Procedure

Study procedure

Group A – Participants in this group will receive Sensory stimulation with early mobility

Sensory stimulation

Outcome measures

Ranchos Los amigos scale for cognitive functioning

Study Reference article

Dissemination

Study status

Discussion

Conclusion

Acknowledgements

References

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