Comparative Utility of Clinical Balance Measures in Traumatic Brain Injury

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Completed

CT.gov ID

NCT02696538

Collaborator

Texas Woman's University (Other)

Enrollment

Location

Arm

23.2

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research study is to investigate how useful three balance tests are in predicting fall risk in the individual with traumatic brain injury (TBI). These tests are the Functional Gait Assessment (FGA), the Berg Balance Scale (BBS), and the mini-Balance Evaluation Systems Test (mini-BESTest).

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury Acquired Brain Injury Accidental Falls	Other: Functional Gait Assessment Other: mini-Balance Evaluation Systems Test Other: Berg Balance Scale	N/A

Detailed Description

The purpose of the proposed study is to investigate the reliability and predictive validity of three balance measures, the Berg Balance Scale (BBS), the Functional Gait Assessment (FGA) and the mini-Balance Evaluation Systems Test (mini-BESTest), among individuals with history of traumatic brain injury. Participants will complete a health history questionnaire and six-month fall history. When available, fall history will be corroborated with a family member that resides with the participant. Participants will complete the Montreal Cognitive Assessment. Each participant will then participate in a 45-minute evaluation using the three performance-based outcome measures, with order randomized, with two blinded assessors. Six and 12 month follow-up of number of falls will occur via telephone. Statistical analysis with investigate the inter-rater reliability, predictive validity of fall risk and to determine cut off scores for fallers vs. non fallers in the population.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Comparative Utility of the Mini-BESTest, Berg Balance Scale, and Functional Gait Assessment to Predict Falls in Individuals After Traumatic Brain Injury

Actual Study Start Date :

Mar 11, 2016

Actual Primary Completion Date :

Feb 16, 2018

Actual Study Completion Date :

Feb 16, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental All participants included in this group and will complete all three outcomes assessment	Other: Functional Gait Assessment Balance assessment Other: mini-Balance Evaluation Systems Test Balance assessment Other: Berg Balance Scale Balance assessment

Arm

Intervention/Treatment

Experimental: Experimental

All participants included in this group and will complete all three outcomes assessment

Other: Functional Gait Assessment

Balance assessment

Other: mini-Balance Evaluation Systems Test

Balance assessment

Other: Berg Balance Scale

Balance assessment

Outcome Measures

Primary Outcome Measures

total score on Functional Gait Assessment [Baseline]
total score on Berg Balance Scale [Baseline]
total on mini-Balance Evaluation System Test [Baseline]
reported fall history [six month]
a fall is defined as unplanned and unexpected contact with the floor or lower surface not due to medical emergency (stroke, seizure, cardiac event) or environmental hazards (chair collapsing, earthquake)
reported fall history [twelve month]
a fall is defined as unplanned and unexpected contact with the floor or lower surface not due to medical emergency (stroke, seizure, cardiac event) or environmental hazards (chair collapsing, earthquake)