Abstract
BackgroundCerebral palsy (CP) is the most common developmental motor disorder in children. Individuals with CP demonstrate abnormal muscle tone and motor control. Within the population of children with CP, between 4% and 17% present dystonic symptoms that may manifest as large errors in movement tasks, high variability in movement trajectories, and undesired movements at rest. These symptoms of dystonia typically worsen with physical intervention exercises.ObjectiveThe aim of this study is to establish the effect of haptic feedback in a virtual reality (VR) game intervention on movement outcomes of children with dystonic CP.MethodsThe protocol describes a randomized controlled trial that uses a VR game-based intervention incorporating fully automated robotic haptic feedback. The study consists of face-to-face assessments of movement before, after, and 1 month following the completion of the 6-session game-based intervention. Children with dystonic CP, aged between 7 and 17 years, will be recruited for this study through posted fliers and laboratory websites along with a group of typically developing (TD) children in the same age range. We anticipate to recruit a total of 68 participants, 34 each with CP and TD. 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.ResultsThe trial has not started and is pending local institutional review board approval.ConclusionsMovement outcomes will be examined for changes in muscle activation and clinical measures in children with dystonic CP and TD children. Paired t tests will be conducted on movement outcomes for both groups of children independently. Positive and negative results will be reported and addressed.Trial RegistrationClinicalTrials.gov NCT03744884; https://clinicaltrials.gov/ct2/show/NCT03744884 (Archived by WebCite at http://www.webcitation.org/74RSvmbZP)International Registered Report Identifier (IRRID)PRR1-10.2196/11470
Highlights
BackgroundCerebral palsy (CP) is the most common developmental motor disorder in children, present in 3.6 of every 1000 live births in the United States [1]
Movement outcomes will be examined for changes in muscle activation and clinical measures in children with dystonic CP and typically developing (TD) children
Paired t tests will be conducted on movement outcomes for both groups of children independently
Summary
All procedures will take place at 2 sites: the Neuroscience of Dance in Health and Disability laboratory located at the University of Illinois at Urbana-Champaign (UIUC) or the Children’s Hospital of Illinois/OSF Saint Francis Medical Center. Participants in the control group will be assessed at a study site approximately 6 times, each lasting a maximum of 1.5 hours. Participants will attend a total of approximately 9 hours for the assessments involved in the study. The accelerometry data will be used to assess smoothness of movement during the execution of a prescribed movement and measures muscle activation patterns during assessments involving the robot-force transducer unit used to measure force and torque outputs within the reachable space of the upper limbs of the participant. Given the wide age range and motor impairment characteristics in the eligibility criteria for this study, we propose a sample size of n=17 with a total number of 68 participants. Physicians involved in the experiment from the Children’s Hospital of Illinois/OSF Saint Francis Medical Center will assist in referring participants and may distribute flyers with contact information regarding the study. JMIR Res Protoc 2019 | vol 8 | iss. 1 | e11470 | p. 8 (page number not for citation purposes)
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