Skip to main content
OpenTrials
Completed

NCT Number: NCT03386968

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cerebral Palsy Acquired Brain Injury Brain Damage, Chronic Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blythedale Children's Hospital

Valhalla, New York, 10595, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active video gaming

Behavioral

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.

Usual Care Physical Therapy

Behavioral

Children will attend their usual care physical therapy appointments at Blythedale.

Primary outcomes

  1. 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

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

Sponsors and collaborators

Lead sponsor

Blythedale Children's Hospital

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 29, 2017
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.