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

Cerebral Palsy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03386968
• Other study ID #: 17-1206TS
• Status: Completed
• Phase: N/A
• Start date: December 7, 2017
• Est. completion date: January 6, 2022

Study information

• Verified date: January 2022
• Source: Blythedale Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: January 6, 2022
• Est. primary completion date: January 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Cerebral Palsy
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Blythedale Children's Hospital	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
Blythedale Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test	The PEDI-CAT measures abilities in three functional domains: Daily Activities, Mobility and Social/Cognitive.	From before intervention to immediately after intervention
Secondary	Change in 10 Meter walk test	Measures time taken for a participant to walk 10 meters	From before intervention to immediately after intervention
Secondary	Change in Gross Motor Function Measure (GMFM) subtest D and E	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
Secondary	Change in Four Square Step Test	Measures how well a patient can change directions while stepping.	From before intervention to immediately after intervention
Secondary	Change in Functional Gait Assessment (FGA)	10-item test that assesses dynamic balance and postural stability during gait.	From before intervention to immediately after intervention
Secondary	Change in Motor Free Visual Perceptual Test (MVPT)-4	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
Secondary	Change in Visually guided weight shift ability as measured by the Smart Balance Master®	Force platform system that tests balance	From before intervention to immediately after intervention
Secondary	Change in Children's Assessment of Participation and Enjoyment	Self-report measures of children's participation in recreation and leisure activities outside of mandated school activities.	From before intervention to immediately after intervention