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

Craig Hospital62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Traumatic Brain Injury

Interventions

Virtual Reality Based ExerciseBEHAVIORAL

A structured, individually tailored, protocol driven, reproducible therapeutic intervention. The study intervention will consist of individually prescribed selections from three off-the-shelf VR games that target the type and severity of balance deficits elicited during the completion of a baseline assessment. Participants randomized to receive this intervention will be assigned a home balance program that utilizes an Xbox Kinect system to provide balance activities.

Standard ExerciseBEHAVIORAL

An individualized home balance exercise program that also targets identified balance system-specific deficits, however, utilizes no VR components.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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.

Locations (1)

Craig Hospital

Englewood, Colorado, United States

Outcomes

Primary Outcomes

Change from Baseline on Community Balance and Mobility (CB&M)

Specifically developed to assess balance function for individuals with TBI. Includes 13 balance based activites such as single leg standing, tandem walking, hopping, running, descending stairs.

Time frame: Baseline, 6-weeks, 12 weeks, 24weeks

Secondary Outcomes

Change from Baseline on Balance Evaluation Systems Test (BESTest)

Used to evaluate balance system function. Movement characteristics and timed criteria are used to rate 36 items on a scale of 0 (maximum limitation) to 3 (within normal limits).

Time frame: Baseline, 6weeks, 12weeks, 24weeks

Change from Baseline on Activity-specific, Behavior Confidence Scale (ABC)

Used to assess fear of falling, the ABC scale includes 16 items that describe everyday community activities and which are scored on a scale of 0 (no confidence) to 100 (complete confidence).

Time frame: Baseline, 6weeks, 12weeks, 24weeks

Change from Baseline on Participation Assessment with Recombined Tools-Objective (PART-O)

This 17-item assessment of community participation will be used to measure overall societal participation.

Time frame: Baseline, 6 weeks, 12weeks, 24weeks

Data from ClinicalTrials.gov

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