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

NCT03386968 | Completed

• 1 other identifier: 17-1206TS
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Acquired Brain Injury

Keywords

virtual reality; hemiplegia; diplegia; video gaming; active video games; Playstation X-Box 360; Rutgers V-Step; Microsoft Kinect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in 10 Meter walk test

  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 Four Square Step Test

  From before intervention to immediately after intervention

• Change in Functional Gait Assessment (FGA)

  From before intervention to immediately after intervention

• Change in Motor Free Visual Perceptual Test (MVPT)-4

  From before intervention to immediately after intervention

Study Arms (2)

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.

Behavioral: Active video gaming

Usual care

ACTIVE COMPARATOR

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

Behavioral: Usual care physical therapy

Interventions

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.

Video gaming

Usual care physical therapy BEHAVIORAL

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

Usual care

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Blythedale Children's Hospital: lead

Study Sites (1)

Blythedale Children's Hospital

Valhalla, New York, 10595, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Brain Injuries; Hemiplegia

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Randomized Block Design will be utilized in order to attempt to "match" subjects according to functional level and diagnosis (cerebral palsy or acquired brain injury). Upon signing consent the subjects will be grouped based on their diagnosis. At that time gait speed for the 10 M Walk Test will be utilized to categorize all participants into a "fast" and "slow" group. (subjects performing the 10 M Walk Test at a speed less than .4 m/s will be placed in the "slow" group, and subjects testing at a speed greater than or equal to .4 m/s will be placed in the "fast" group After this determination is made, subjects will be randomized to "control" (usual care), and "intervention" one therapy session replaced with a session utilizing Active video games and the Rutger's V-step. A minimum of 2 subjects per grouping will be sought in order to analyze for differences.

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 29, 2017
• Study Start: December 7, 2017
• Primary Completion: January 6, 2022
• Study Completion: January 6, 2022
• Last Updated: January 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)