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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 6, 2022

Interventions

  • 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.
  • Behavioral: Usual care physical therapy
    • Children will attend their usual care physical therapy appointments at Blythedale.

Arms, Groups and Cohorts

  • 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.
  • Active Comparator: Usual care
    • Children will receive their usual care in the physical therapy program at Blythedale.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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 MasterĀ®
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 7 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Blythedale Children’s Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Teresa Smith, MSPT, 914-592-7555, teresas@blythedale.org

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