Virtual Reality (VR) Treatment for Balance Problems in Traumatic Brain Injury (TBI)

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Craig Hospital

Status

Completed

Conditions

Traumatic Brain Injury

Treatments

Behavioral: Standard Exercise
Behavioral: Virtual Reality Based Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT01794585
H133A120032-2

Details and patient eligibility

About

The purpose of this study is to evaluate the effectivenes of a home-based physical therapy program designed to improve balance following traumatic brain injury by incorporating the use of a virtual reality system.

Enrollment

62 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Has sustained a documented TBI that required an inpatient rehabilitation program;
  • is at least one year post TBI;
  • is at least 18 and no more than 64 years of age at the time of enrollment;
  • is English or Spanish speaking
  • is at least three months beyond completion of formal PT, including acute inpatient rehabilitation, outpatient and home-based therapy;
  • provides written medical clearance for participation in an in-home balance exercise program;
  • ambulates independently within the home (with assistive devices and/or orthotics as needed);
  • has active range of motion of bilateral upper extremities of at least 90 degrees of abduction to allow for control of the VR system;
  • completes a 15 minute trial using a VR system in the absence of a negative physical or behavioral reaction;
  • self-reports ongoing balance deficits and demonstrate such deficits by scoring at or below one standard deviation above the mean (75 or below) on the CB&M; and
  • provides informed consent, or has a guardian available to provide consent.

Exclusion criteria

  • has a history of another medical illness or neurological disorder which may affect balance;
  • has experienced a seizure within the last year;
  • has a history of psychiatric disorder requiring hospitalization;
  • is currently participating in another RCT;
  • is currently using VR technology to address specific balance goals;
  • is unable to travel to Craig for assessments throughout the study period;
  • is unable to communicate effectively to complete standardized assessments;
  • has cognitive impairment that precludes completion of baseline testing;
  • is unavailable to participate in 12 continuous weeks of therapy;
  • has no access to television able to connect to VR-gaming system; and
  • reports inadequate space required for VR-gaming system sensors.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

62 participants in 2 patient groups

Virtual Reality Based Exercise
Experimental group
Treatment:
Behavioral: Virtual Reality Based Exercise
Standard Exercise
Active Comparator group
Treatment:
Behavioral: Standard Exercise

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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