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Clinical Trials/NCT02696538
NCT02696538
Completed
Not Applicable

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

The University of Texas Health Science Center, Houston1 site in 1 country20 target enrollmentMarch 11, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
20
Locations
1
Primary Endpoint
total on mini-Balance Evaluation System Test
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 11, 2016
End Date
February 16, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marissa Lyon

Physical Therapist

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

Outcomes

Primary Outcomes

total on mini-Balance Evaluation System Test

Time Frame: Baseline

total score on Berg Balance Scale

Time Frame: Baseline

total score on Functional Gait Assessment

Time Frame: Baseline

reported fall history

Time Frame: 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 Outcomes

  • Montreal Cognitive Assessment(Baseline)

Study Sites (1)

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