Virtual Reality and Active Video Games to Improve Balance in Children With Brain Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03386968|
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : May 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy Acquired Brain Injury||Behavioral: Active video gaming Behavioral: Usual care physical therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||December 7, 2017|
|Estimated Primary Completion Date :||December 6, 2019|
|Estimated Study Completion Date :||December 6, 2020|
Experimental: Video gaming
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
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.
Active Comparator: Usual care
Children will receive their usual care in the physical therapy program at Blythedale.
Behavioral: Usual care physical therapy
Children will attend their usual care physical therapy appointments at Blythedale.
- Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test [ Time Frame: From before intervention to immediately after intervention ]The PEDI-CAT measures abilities in three functional domains: Daily Activities, Mobility and Social/Cognitive.
- Change in 10 Meter walk test [ Time Frame: From before intervention to immediately after intervention ]Measures time taken for a participant to walk 10 meters
- Change in Gross Motor Function Measure (GMFM) subtest D and E [ Time Frame: From before intervention to immediately after intervention ]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 [ Time Frame: From before intervention to immediately after intervention ]Measures how well a patient can change directions while stepping.
- Change in Functional Gait Assessment (FGA) [ Time Frame: From before intervention to immediately after intervention ]10-item test that assesses dynamic balance and postural stability during gait.
- Change in Motor Free Visual Perceptual Test (MVPT)-4 [ Time Frame: From before intervention to immediately after intervention ]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® [ Time Frame: From before intervention to immediately after intervention ]Force platform system that tests balance
- Change in Children's Assessment of Participation and Enjoyment [ Time Frame: From before intervention to immediately after intervention ]Self-report measures of children's participation in recreation and leisure activities outside of mandated school activities.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386968
|Contact: Teresa Smith, MSPT||914-592-7555 ext firstname.lastname@example.org|
|United States, New York|
|Blythedale Children's Hospital||Recruiting|
|Valhalla, New York, United States, 10595|
|Contact: Linda Fieback, PT 914-592-7138 email@example.com|
|Sub-Investigator: Mark Felsenfeld, PT|
|Sub-Investigator: Teresa Smith, PT|