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Clinical Trials/NCT03386968
NCT03386968CompletedNot Applicable

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

Blythedale Children's Hospital1 site in 1 country4 target enrollmentStarted: December 7, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
4
Locations
1
Primary Endpoint
Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
7 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Arms & Interventions

Video gaming

Experimental

A child's usual physical therapy session will be replaced with a session utilizing Active video games and the Rutger's V-step.

Intervention: Active video gaming (Behavioral)

Usual care

Active Comparator

Children will receive their usual care in the physical therapy program at Blythedale.

Intervention: Usual care physical therapy (Behavioral)

Outcomes

Primary Outcomes

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 Outcomes

  • Change in Functional Gait Assessment (FGA)(From before intervention to immediately after intervention)
  • Change in 10 Meter walk test(From before intervention to immediately after intervention)
  • Change in Four Square Step Test(From before intervention to immediately after intervention)
  • Change in Visually guided weight shift ability as measured by the Smart Balance Master®(From before intervention to immediately after intervention)
  • Change in Gross Motor Function Measure (GMFM) subtest D and E(From before intervention to immediately after intervention)
  • Change in Motor Free Visual Perceptual Test (MVPT)-4(From before intervention to immediately after intervention)
  • Change in Children's Assessment of Participation and Enjoyment(From before intervention to immediately after intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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