Comparative Utility of Clinical Balance Measures in Traumatic Brain Injury

NCT ID: NCT02696538

Last Updated: 2018-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-11

Study Completion Date

2018-02-16

Brief Summary

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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

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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.

Conditions

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Traumatic Brain Injury Acquired Brain Injury Accidental Falls

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental

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Group Type EXPERIMENTAL

Functional Gait Assessment

Intervention Type OTHER

Balance assessment

mini-Balance Evaluation Systems Test

Intervention Type OTHER

Balance assessment

Berg Balance Scale

Intervention Type OTHER

Balance assessment

Interventions

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Functional Gait Assessment

Balance assessment

Intervention Type OTHER

mini-Balance Evaluation Systems Test

Balance assessment

Intervention Type OTHER

Berg Balance Scale

Balance assessment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Texas Woman's University

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Marissa Lyon

Physical Therapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marissa F Lyon, DPT

Role: PRINCIPAL_INVESTIGATOR

Memorial Hermann

Locations

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Marissa Lyon

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-MH-15-0656

Identifier Type: -

Identifier Source: org_study_id

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