Virtual Reality and Active Video Games to Improve Balance in Children With Brain Injury

Study Overview
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Brief Summary
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The purpose of this pilot feasibility study is to assess the feasibility of using the Playstation Xbox 360 and Rutgers V-step via a Kinect Sensor with active video game software as a part of a physical therapy intervention to improve obstacle negotiation, gait speed, and stair negotiation in ambulatory children with Cerebral Palsy (CP) hemiparesis or spastic diplegia, or non-progressive brain injury (BI). Children will be assessed using perceptual, balance, functional and gait assessments.

Official Title
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Use of Low-Cost Virtual Reality and Active Video Games to Improve Balance and Perceptual Skills in Children With Cerebral Palsy and Brain Injury

Conditions
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Cerebral Palsy, Acquired Brain Injury

Intervention / Treatment
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* Behavioral: Active video gaming
* Behavioral: Usual care physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 7-17 Diagnosis of Cerebral Palsy or Diagnosis of Acquired Brain Injury Ambulatory with or without an assistive device x 150 feet Cognition and attention ability sufficient to be successful in video game play and to follow instructions of the investigator. Able to complete testing process. Current patient at Blythedale Children's Hospital program (Expected Length of Stay/availability for study of approximately 8 weeks) Exclusion Criteria: Any history of photosensitive epilepsy or seizures triggered by exposure to flashing lights, television or video games Attention or behavior problems that prevent the successful completion of game play Any acute musculoskeletal injury that limits weight bearing on one lower extremity (due to orthopedist concerns for fracture or injury) Any medical condition that prevents the child from tolerating exercise due to cardiovascular conditions

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Randomized Block Design will be utilized in order to attempt to match subjects according to functional level and diagnosis (cerebral palsy or acquired brain injury). Upon signing consent the subjects will be grouped based on their diagnosis. At that time gait speed for the 10 M Walk Test will be utilized to categorize all participants into a fast and slow group. (subjects performing the 10 M Walk Test at a speed less than .4 m/s will be placed in the slow group, and subjects testing at a speed greater than or equal to .4 m/s will be placed in the fast group After this determination is made, subjects will be randomized to control (usual care), and intervention one therapy session replaced with a session utilizing Active video games and the Rutger's V-step. A minimum of 2 subjects per grouping will be sought in order to analyze for differences.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video gaming<br>A child's usual physical therapy session will be replaced with a session utilizing Active video games and the Rutger's V-step. | Behavioral: Active video gaming<br>* Children will visit Blythedale for 8 sessions, one 45-session visit per week, in place of one of the child's typical physical therapy sessions. During each session, children will play a video game on the X-Box Kinect system, using the games Kinect Adventures and Kinect Sports. The child will first play a Kinect Adventures game, which requires ambulating, ducking, and dodging one's way through an obstacle course.<br>|
| Active Comparator: Usual care<br>Children will receive their usual care in the physical therapy program at Blythedale. | Behavioral: Usual care physical therapy<br>* Children will attend their usual care physical therapy appointments at Blythedale.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test | The PEDI-CAT measures abilities in three functional domains: Daily Activities, Mobility and Social/Cognitive. | From before intervention to immediately after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 10 Meter walk test | Measures time taken for a participant to walk 10 meters | From before intervention to immediately after intervention | 
| Change in Gross Motor Function Measure (GMFM) subtest D and E | The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. | From before intervention to immediately after intervention | 
| Change in Four Square Step Test | Measures how well a patient can change directions while stepping. | From before intervention to immediately after intervention | 
| Change in Functional Gait Assessment (FGA) | 10-item test that assesses dynamic balance and postural stability during gait. | From before intervention to immediately after intervention | 
| Change in Motor Free Visual Perceptual Test (MVPT)-4 | The MVPT-4 assesses five categories of visual perception: Visual Discrimination: Ability to discriminate dominant features of different objects, including the ability to discriminate position, shapes, and forms. | From before intervention to immediately after intervention | 
| Change in Visually guided weight shift ability as measured by the Smart Balance Master® | Force platform system that tests balance | From before intervention to immediately after intervention | 
| Change in Children's Assessment of Participation and Enjoyment | Self-report measures of children's participation in recreation and leisure activities outside of mandated school activities. | From before intervention to immediately after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality, hemiplegia, diplegia, video gaming, active video games, Playstation X-Box 360, Rutgers V-Step, Microsoft Kinect