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OpenTrials
Completed

NCT Number: NCT02696538

Comparative Utility of Clinical Balance Measures in 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marissa Lyon

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional Gait Assessment

Other

Balance assessment

Mini-Balance Evaluation Systems Test

Other

Balance assessment

Berg balance scale

Other

Balance assessment

Primary outcomes

  1. total score on Functional Gait Assessment

    Time frame: Baseline

  2. total score on Berg Balance Scale

    Time frame: Baseline

  3. total on mini-Balance Evaluation System Test

    Time frame: Baseline

  4. reported fall history

    Time frame: six month

    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)

  5. reported fall history

    Time frame: twelve month

    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)

Secondary outcomes

  1. Montreal Cognitive Assessment

    Time frame: Baseline

    assessment of mild cognitive deficits

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Texas Woman's University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 2, 2016
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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