- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04568070
Turkish Version of the Mini-BESTest: Transcultural Adaptation and Validation Study in Stroke Patients
September 28, 2020 updated by: Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
"mini-BESTest (Turkish version)", "Berg Balance Test", "Timed Up and Go Test" and "Functional Reach Test" will be used for balance measurement in patients and the correlation of the mini-BEST with these tests will be checked.
Study Overview
Status
Unknown
Conditions
Detailed Description
The first part of the study is the Turkish translation of mini-BESTest.
After the translation process, "mini-BESTest (Turkish version)", "Berg Balance Test", "Timed Up and Go Test" and "Functional Reach Test" will be used for balance measurement in patients and the correlation of the mini-BEST with these tests will be checked.
All tests will be applied by 2 researchers on the same day, 2 times with 10 minutes intervals.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bilinç Karatekin
- Phone Number: +905368308709
- Email: bilincdogruoz@hotmail.com
Study Contact Backup
- Name: Afitap Icagasioglu
- Phone Number: +905324129373
- Email: afitapi@gmail.com
Study Locations
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-
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Istanbul, Turkey, 34732
- Recruiting
- Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department
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Sub-Investigator:
- Afitap Icagasioglu, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Chronic stroke patients
- Patients who can execute commands
- Patients who are ambulatory enough to complete most balance tasks
- Patients participating in the study voluntarily
Exclusion Criteria:
- Acute stroke patients
- Patients who cannot execute commands
- Non-ambulatory patients
- Pediatric patients and pregnant patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stroke
Stroke patients who applied to the Physical Medicine and Rehabilitation outpatient clinic, met the inclusion criteria and volunteered to participate in the study
|
Balance evaluation test that has 14 tasks leading to a total possible score of 28 points requires only 10 to 15 minutes to conduct.
The scale is a 14-item objective measure designed to assess static balance and fall risk in adult populations.
It is a simple test used to assess a person's mobility and requires both static and dynamic balance.
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
The Functional Reach Test is a single item test developed as a quick screen for balance problems in older adults.
A score of 6 or less indicates a significant increased risk for falls.
A score between 6-10 inches indicates a moderate risk for falls.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mini-BESTest
Time Frame: 3 months
|
Balance evaluation test that has 14 tasks leading to a total possible score of 28 points.
|
3 months
|
Berg Balance Scale
Time Frame: 3 months
|
The scale is a 14-item objective measure designed to assess static balance and fall risk in adult populations
|
3 months
|
Timed Up and Go Test
Time Frame: 3 months
|
It is a test used to assess a person's mobility and requires both static and dynamic balance
|
3 months
|
Functional Reach Test
Time Frame: 3 months
|
The Functional Reach Test is a single item test developed as a quick screen for balance problems in older adults
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bilinç Karatekin, Istanbul Medeniyet University Physical Therapy And Rehabilitation Department
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 24, 2020
Primary Completion (Anticipated)
December 24, 2020
Study Completion (Anticipated)
December 30, 2020
Study Registration Dates
First Submitted
September 24, 2020
First Submitted That Met QC Criteria
September 28, 2020
First Posted (Actual)
September 29, 2020
Study Record Updates
Last Update Posted (Actual)
September 29, 2020
Last Update Submitted That Met QC Criteria
September 28, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMU Stroke
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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