Traumatic Brain InjuryNCT02696538
Comparative Utility of Clinical Balance Measures in Traumatic Brain Injury
A study testing Functional Gait Assessment, mini-Balance Evaluation Systems Test and Berg Balance Scale in people with Traumatic Brain Injury and Acquired Brain Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Acquired Brain Injury, Accidental Falls
- What is being tested?
- Functional Gait Assessment, mini-Balance Evaluation Systems Test and Berg Balance Scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2016to 16 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- presence of partial or non-weight bearing on a lower extremity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Being tested
- Functional Gait Assessment, mini-Balance Evaluation Systems Test, Berg Balance Scale
- 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
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Gait AssessmentOther
Balance assessment
mini-Balance Evaluation Systems TestOther
Balance assessment
Berg Balance ScaleOther
Balance assessment
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | All participants included in this group and will complete all three outcomes assessment Receives: Other: Functional Gait Assessment; Other: mini-Balance Evaluation Systems Test; Other: Berg Balance Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
total score on Functional Gait Assessment
Measured: Baseline
total score on Berg Balance Scale
Measured: Baseline
total on mini-Balance Evaluation System Test
Measured: 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)
Measured: 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)
Measured: twelve month
Secondary outcomes (1)
Montreal Cognitive Assessment
assessment of mild cognitive deficits
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study start11 Mar 2016
- Primary completion16 Feb 2018
- Study completion16 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Woman's University
- Responsible party
- Principal investigator, Marissa Lyon, The University of Texas Health Science Center, Houston
- Investigators
- Marissa F Lyon, DPT, Principal investigator, Memorial Hermann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696538
- Sponsor's protocol ID
- HSC-MH-15-0656
- Status last verified
- Oct 2018
- First submitted
- 26 Feb 2016
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Utility of the Mini-BESTest, Berg Balance Scale, and Functional Gait Assessment to Predict Falls in Individuals After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02696538
- Acronym / sponsor ID
- HSC-MH-15-0656
- Keywords
- Fall risk, Rehabiliation, Physical Therapy, Functional Gait Assessment, mini-Balance Evaluation Systems Test, Berg Balance Scale, Psychometric properties, Validity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Texas Woman's University
- Study start
- 11 Mar 2016 (actual)
- Primary completion
- 16 Feb 2018 (actual)
- Study completion
- 16 Feb 2018 (actual)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Functional Gait Assessment, Other: mini-Balance Evaluation Systems Test, Other: Berg Balance ScaleAll participants included in this group and will complete all three outcomes assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- presence of partial or non-weight bearing on a lower extremity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Gait AssessmentBalance assessment | Other | Experimental |
| mini-Balance Evaluation Systems TestBalance assessment | Other | Experimental |
| Berg Balance ScaleBalance assessment | Other | Experimental |
Primary outcome
total score on Functional Gait Assessment
Time frame: Baseline
total score on Berg Balance Scale
Time frame: Baseline
total on mini-Balance Evaluation System Test
Time frame: Baseline
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)
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)
1 secondary outcome
Montreal Cognitive Assessment
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Traumatic Brain Injury
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marissa F Lyon, DPT principal investigator
Memorial Hermann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Gait Assessment, mini-Balance Evaluation Systems Test and Berg Balance Scale in people with Traumatic Brain Injury and Acquired Brain Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total score on Functional Gait Assessment (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.