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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02696538
Other study ID # HSC-MH-15-0656
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 11, 2016
Est. completion date February 16, 2018

Study information

Verified date October 2018
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date February 16, 2018
Est. primary completion date February 16, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Other:
Functional Gait Assessment
Balance assessment
mini-Balance Evaluation Systems Test
Balance assessment
Berg Balance Scale
Balance assessment

Locations

Country Name City State
United States Marissa Lyon Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston Texas Woman's University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary total score on Functional Gait Assessment Baseline
Primary total score on Berg Balance Scale Baseline
Primary total on mini-Balance Evaluation System Test Baseline
Primary 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
Primary 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 Montreal Cognitive Assessment assessment of mild cognitive deficits Baseline
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