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

Not Applicable

Completed

• Conditions: Acquired Brain Injury; Cerebral Palsy
• Interventions: Behavioral: Active video gaming; Behavioral: Usual care physical therapy

• Registration Number: NCT03386968
• Lead Sponsor: Blythedale Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-07
• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-21
• Study First Posted: 2017-12-29
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-05
• Primary Completion: 2022-01-06
• Study Completion: 2022-01-06
• Last Update Posted: 2022-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video gaming	Active 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.
Usual care	Usual care physical therapy	Children will receive their usual care in the physical therapy program at Blythedale.

Primary Outcome Measures

Name	Time	Method
Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test	From before intervention to immediately after intervention	The PEDI-CAT measures abilities in three functional domains: Daily Activities, Mobility and Social/Cognitive.

Secondary Outcome Measures

Name	Time	Method
Change in Functional Gait Assessment (FGA)	From before intervention to immediately after intervention	10-item test that assesses dynamic balance and postural stability during gait.
Change in 10 Meter walk test	From before intervention to immediately after intervention	Measures time taken for a participant to walk 10 meters
Change in Four Square Step Test	From before intervention to immediately after intervention	Measures how well a patient can change directions while stepping.
Change in Visually guided weight shift ability as measured by the Smart Balance Master®	From before intervention to immediately after intervention	Force platform system that tests balance
Change in Gross Motor Function Measure (GMFM) subtest D and E	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 Motor Free Visual Perceptual Test (MVPT)-4	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 Children's Assessment of Participation and Enjoyment	From before intervention to immediately after intervention	Self-report measures of children's participation in recreation and leisure activities outside of mandated school activities.

Trial Locations

Locations (1)

Blythedale Children's Hospital; 🇺🇸 Valhalla, New York, United States