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

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).

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury; Acquired Brain Injury; Accidental Falls
• Intervention / Treatment: Other: Functional Gait Assessment; Other: mini-Balance Evaluation Systems Test; Other: Berg Balance Scale

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Marissa Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; All participants included in this group and will complete all three outcomes assessment	Other: Functional Gait Assessment; Balance assessment; Other: mini-Balance Evaluation Systems Test; Balance assessment; Other: Berg Balance Scale; Balance assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total score on Functional Gait Assessment		Baseline
total score on Berg Balance Scale		Baseline
total on mini-Balance Evaluation System Test		Baseline
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment	assessment of mild cognitive deficits	Baseline

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Texas Woman's University
• Investigators: Principal Investigator: Marissa F Lyon, DPT, Memorial Hermann

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2016
• Primary Completion (Actual): February 16, 2018
• Study Completion (Actual): February 16, 2018

Study Registration Dates

• First Submitted: February 26, 2016
• First Submitted That Met QC Criteria: February 26, 2016
• First Posted (Estimate): March 2, 2016

Study Record Updates

• Last Update Posted (Actual): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Validity; Physical Therapy; Montreal Cognitive Assessment; Inter-rater reliability; Fall risk; Berg Balance Scale; Psychometric properties; Rehabiliation; Functional Gait Assessment; mini-Balance Evaluation Systems Test
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: HSC-MH-15-0656

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No