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Comparative Utility of Clinical Balance Measures in Traumatic Brain Injury

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02696538
Enrollment
20
Registered
2016-03-02
Start date
2016-03-11
Completion date
2018-02-16
Last updated
2018-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury, Acquired Brain Injury, Accidental Falls

Keywords

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

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.

Interventions

OTHERFunctional Gait Assessment

Balance assessment

Balance assessment

Sponsors

Texas Woman's University
CollaboratorOTHER
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
total score on Functional Gait AssessmentBaseline
total score on Berg Balance ScaleBaseline
total on mini-Balance Evaluation System TestBaseline
reported fall historysix montha 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

MeasureTime frameDescription
Montreal Cognitive AssessmentBaselineassessment of mild cognitive deficits

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026