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

January 5, 2022 updated by: Blythedale Children's Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Valhalla, New York, United States, 10595
        • Blythedale Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From before intervention to immediately after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From before intervention to immediately after intervention
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.
From before intervention to immediately after intervention
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.
From before intervention to immediately after intervention
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.
From before intervention to immediately after intervention
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.
From before intervention to immediately after intervention
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
From before intervention to immediately after intervention
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.
From before intervention to immediately after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Blythedale Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 7, 2017

Primary Completion (ACTUAL)

January 6, 2022

Study Completion (ACTUAL)

January 6, 2022

Study Registration Dates

First Submitted

December 7, 2017

First Submitted That Met QC Criteria

December 21, 2017

First Posted (ACTUAL)

December 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 10, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-1206TS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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