Comparative Utility of Clinical Balance Measures in Traumatic Brain Injury

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Traumatic Brain Injury, Acquired Brain Injury, Accidental Falls

Intervention / Treatment
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* Other: Functional Gait Assessment
* Other: mini-Balance Evaluation Systems Test
* Other: Berg Balance Scale


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | six month | 
| reported fall history | 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) | twelve month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment | assessment of mild cognitive deficits | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fall risk, Rehabiliation, Physical Therapy, Functional Gait Assessment, mini-Balance Evaluation Systems Test, Berg Balance Scale, Psychometric properties, Validity, Inter-rater reliability, Montreal Cognitive Assessment