Back to resultsComparative Utility of Clinical Balance Measures in Traumatic Brain Injury
Primary Purpose
Traumatic Brain Injury, Acquired Brain Injury, Accidental Falls
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional Gait Assessment
mini-Balance Evaluation Systems Test
Berg Balance Scale
Sponsored by
About this trial
This is an interventional diagnostic trial for Traumatic Brain Injury focused on measuring 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
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
Sites / Locations
- Marissa Lyon
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
All participants included in this group and will complete all three outcomes assessment
Outcomes
Primary Outcome Measures
total score on Functional Gait Assessment
total score on Berg Balance Scale
total on mini-Balance Evaluation System Test
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)
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)
Secondary Outcome Measures
Montreal Cognitive Assessment
assessment of mild cognitive deficits
Full Information
NCT ID
NCT02696538
First Posted
February 26, 2016
Last Updated
October 10, 2018
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Texas Woman's University
1. Study Identification
Unique Protocol Identification Number
NCT02696538
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 11, 2016 (Actual)
Primary Completion Date
February 16, 2018 (Actual)
Study Completion Date
February 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Texas Woman's University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
All participants included in this group and will complete all three outcomes assessment
Intervention Type
Other
Intervention Name(s)
Functional Gait Assessment
Intervention Description
Balance assessment
Intervention Type
Other
Intervention Name(s)
mini-Balance Evaluation Systems Test
Intervention Description
Balance assessment
Intervention Type
Other
Intervention Name(s)
Berg Balance Scale
Intervention Description
Balance assessment
Primary Outcome Measure Information:
Title
total score on Functional Gait Assessment
Time Frame
Baseline
Title
total score on Berg Balance Scale
Time Frame
Baseline
Title
total on mini-Balance Evaluation System Test
Time Frame
Baseline
Title
reported fall history
Description
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)
Time Frame
six month
Title
reported fall history
Description
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)
Time Frame
twelve month
Secondary Outcome Measure Information:
Title
Montreal Cognitive Assessment
Description
assessment of mild cognitive deficits
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marissa F Lyon, DPT
Organizational Affiliation
Memorial Hermann
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marissa Lyon
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Utility of Clinical Balance Measures in Traumatic Brain Injury
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