Comparative Utility of Clinical Balance Measures in Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02696538
• Other study ID #: HSC-MH-15-0656
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Accidental Falls
• Acquired Brain Injury
• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

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