Clinical trial NCT02696538: Comparative Utility of Clinical Balance Measures in Traumatic Brain Injury
Official title: Comparative Utility of the Mini-BESTest, Berg Balance Scale, and Functional Gait Assessment to Predict Falls in Individuals After Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Texas Woman's University
First posted: 2016-03-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: total score on Functional Gait Assessment
timeFrame: Baseline
measure: total score on Berg Balance Scale
timeFrame: Baseline
measure: total on mini-Balance Evaluation System Test
timeFrame: Baseline
measure: reported fall history
timeFrame: six month
measure: reported fall history
timeFrame: twelve month
Secondary outcomes:
measure: Montreal Cognitive Assessment
timeFrame: Baseline
Other outcomes:
Locations:
city: Houston
country: United States
facility: Marissa Lyon
state: Texas
Study officials:
affiliation: Memorial Hermann
name: Marissa F Lyon, DPT
role: PRINCIPAL_INVESTIGATOR
References: