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

NCT ID: NCT03386968

Last Updated: 2022-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-07

Study Completion Date

2022-01-06

Brief Summary

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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

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Conditions

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Cerebral Palsy Acquired Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Active video gaming

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Usual care physical therapy

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Usual care physical therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Blythedale Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Blythedale Children's Hospital

Valhalla, New York, United States

Site Status

Countries

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United States

Other Identifiers

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17-1206TS

Identifier Type: -

Identifier Source: org_study_id

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