Back to resultsVirtual Reality and Active Video Games to Improve Balance in Children With Brain Injury
Primary Purpose
Cerebral Palsy, Acquired Brain Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active video gaming
Usual care physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring virtual reality, hemiplegia, diplegia, video gaming, active video games, Playstation X-Box 360, Rutgers V-Step, Microsoft Kinect
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
Sites / Locations
- Blythedale Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Video gaming
Usual care
Arm Description
A child's usual physical therapy session will be replaced with a session utilizing Active video games and the Rutger's V-step.
Children will receive their usual care in the physical therapy program at Blythedale.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in 10 Meter walk test
Measures time taken for a participant to walk 10 meters
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.
Change in Four Square Step Test
Measures how well a patient can change directions while stepping.
Change in Functional Gait Assessment (FGA)
10-item test that assesses dynamic balance and postural stability during gait.
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.
Change in Visually guided weight shift ability as measured by the Smart Balance Master®
Force platform system that tests balance
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.
Full Information
NCT ID
NCT03386968
First Posted
December 7, 2017
Last Updated
January 5, 2022
Sponsor
Blythedale Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03386968
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 7, 2017 (Actual)
Primary Completion Date
January 6, 2022 (Actual)
Study Completion Date
January 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Blythedale Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Acquired Brain Injury
Keywords
virtual reality, hemiplegia, diplegia, video gaming, active video games, Playstation X-Box 360, Rutgers V-Step, Microsoft Kinect
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Video gaming
Arm Type
Experimental
Arm Description
A child's usual physical therapy session will be replaced with a session utilizing Active video games and the Rutger's V-step.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Children will receive their usual care in the physical therapy program at Blythedale.
Intervention Type
Behavioral
Intervention Name(s)
Active video gaming
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care physical therapy
Intervention Description
Children will attend their usual care physical therapy appointments at Blythedale.
Primary Outcome Measure Information:
Title
Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test
Description
The PEDI-CAT measures abilities in three functional domains: Daily Activities, Mobility and Social/Cognitive.
Time Frame
From before intervention to immediately after intervention
Secondary Outcome Measure Information:
Title
Change in 10 Meter walk test
Description
Measures time taken for a participant to walk 10 meters
Time Frame
From before intervention to immediately after intervention
Title
Change in Gross Motor Function Measure (GMFM) subtest D and E
Description
The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy.
Time Frame
From before intervention to immediately after intervention
Title
Change in Four Square Step Test
Description
Measures how well a patient can change directions while stepping.
Time Frame
From before intervention to immediately after intervention
Title
Change in Functional Gait Assessment (FGA)
Description
10-item test that assesses dynamic balance and postural stability during gait.
Time Frame
From before intervention to immediately after intervention
Title
Change in Motor Free Visual Perceptual Test (MVPT)-4
Description
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.
Time Frame
From before intervention to immediately after intervention
Title
Change in Visually guided weight shift ability as measured by the Smart Balance Master®
Description
Force platform system that tests balance
Time Frame
From before intervention to immediately after intervention
Title
Change in Children's Assessment of Participation and Enjoyment
Description
Self-report measures of children's participation in recreation and leisure activities outside of mandated school activities.
Time Frame
From before intervention to immediately after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Blythedale Children's Hospital
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Reality and Active Video Games to Improve Balance in Children With Brain Injury
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