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Clinical Trials/NCT02696538
NCT02696538CompletedNot 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, Houston2 sites in 1 country20 target enrollmentStarted: March 11, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
total on mini-Balance Evaluation System Test

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Experimental

Experimental

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

Intervention: Berg Balance Scale (Other)

Experimental

Experimental

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

Intervention: Functional Gait Assessment (Other)

Experimental

Experimental

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

Intervention: mini-Balance Evaluation Systems Test (Other)

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marissa Lyon

Physical Therapist

The University of Texas Health Science Center, Houston

Study Sites (2)

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