JMIR Publications

ABSTRACT

Background:

Cerebral palsy is the most common developmental motor disorder in children. Individuals with cerebral palsy demonstrate abnormal muscle tone and motor control. Within this population, between 4% and 17% present dystonic symptoms, which may manifest as large errors in movement tasks, high variability in movement trajectories, and undesired movements at rest. Symptoms of dystonia typically worsen with physical intervention exercises.

Objective:

The aim of this study is to establish the effect of haptic feedback in a virtual reality game intervention on movement outcomes of children with dystonic cerebral palsy.

Methods:

The protocol describes a randomized controlled trial that uses a virtual reality game-based intervention incorporating fully-automated robotic haptic feedback. The study consists of face-to-face assessments of movement before, after, and one-month following the completion of the six-session game-based intervention. Children with dystonic cerebral palsy between the ages of 7 and 17 will be recruited for this study through online and offline methods along with a group of typically developing children in the same age range. We anticipate to recruit a total of 68 participants, 34 with cerebral palsy and 34 typically developing. Both groups of children will be randomly allocated into an intervention or control group using a blocked randomization method. The primary outcome measure will be the smoothness index of the interaction force with the robot and of the accelerometry signals of sensors placed on the upper limb segments. Secondary outcomes include a battery of clinical tests and a quantitative measure of spasticity. Assessors administering clinical measures will be blinded. All sessions will be administered on-site by research personnel.

Results:

The trial has not started and is pending local IRB approval. The trial is in ClinicalTrials.gov, NCT03744884.

Conclusions:

Movement outcomes will be examined for changes in muscle activation and clinical measures in children with dystonic cerebral palsy and typically developing children. Pair t-tests will be conducted on movement outcomes for both groups of children independently. Clinical Trial: Trial Registration: ClinicalTrials.gov, NCT03744884.