Clinical trial NCT03386968: Virtual Reality and Active Video Games to Improve Balance in Children With Brain Injury
Official title: Use of Low-Cost Virtual Reality and Active Video Games to Improve Balance and Perceptual Skills in Children With Cerebral Palsy and Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Acquired Brain Injury
Keywords: virtual reality
hemiplegia
diplegia
video gaming
active video games
Playstation X-Box 360
Rutgers V-Step
Microsoft Kinect
Lead sponsor: Blythedale Children's Hospital
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 4
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test
timeFrame: From before intervention to immediately after intervention
Secondary outcomes:
measure: Change in 10 Meter walk test
timeFrame: From before intervention to immediately after intervention
measure: Change in Gross Motor Function Measure (GMFM) subtest D and E
timeFrame: From before intervention to immediately after intervention
measure: Change in Four Square Step Test
timeFrame: From before intervention to immediately after intervention
measure: Change in Functional Gait Assessment (FGA)
timeFrame: From before intervention to immediately after intervention
measure: Change in Motor Free Visual Perceptual Test (MVPT)-4
timeFrame: From before intervention to immediately after intervention
measure: Change in Visually guided weight shift ability as measured by the Smart Balance Master®
timeFrame: From before intervention to immediately after intervention
measure: Change in Children's Assessment of Participation and Enjoyment
timeFrame: From before intervention to immediately after intervention
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: Blythedale Children's Hospital
state: New York
Study officials:
References: