Comparative Utility of Clinical Balance Measures in Traumatic Brain Injury

Not Applicable

Completed

• Conditions: Accidental Falls; Traumatic Brain Injury; Acquired Brain Injury
• Interventions: Other: Functional Gait Assessment; Other: mini-Balance Evaluation Systems Test; Other: Berg Balance Scale

• Registration Number: NCT02696538
• Lead Sponsor: The University of Texas Health Science Center, Houston

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).

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 Timeline

• Study First Submitted: 2016-02-26
• Study First Submitted QC: 2016-02-26
• Study First Posted: 2016-03-02
• Study Start: 2016-03-11
• Primary Completion: 2018-02-16
• Study Completion: 2018-02-16
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• community dwelling
• medically stable
• able to stand at least one minute unsupported (with/without assistive device)
• able to ambulate 20 feet (with/without assistance or assistive device)
• able to follow one step instructions or visual demonstrations.

Exclusion Criteria

• presence of partial or non-weight bearing on a lower extremity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Functional Gait Assessment	All participants included in this group and will complete all three outcomes assessment
Experimental	Berg Balance Scale	All participants included in this group and will complete all three outcomes assessment
Experimental	mini-Balance Evaluation Systems Test	All participants included in this group and will complete all three outcomes assessment

Primary Outcome Measures

Name	Time	Method
total on mini-Balance Evaluation System Test	Baseline
total score on Berg Balance Scale	Baseline
total score on Functional Gait Assessment	Baseline
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)

Secondary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment	Baseline	assessment of mild cognitive deficits

Trial Locations

Locations (1)

Marissa Lyon; 🇺🇸 Houston, Texas, United States