StrokeNCT04568070
Turkish Version of the Mini-BESTest: Transcultural Adaptation and Validation Study in Stroke Patients
A study testing mini-BESTest (Mini-Balance Evaluation Systems Test), Berg Balance Scale and Timed Up and Go Test in people with Stroke and Balance; Distorted, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
"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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Balance; Distorted
- What is being tested?
- mini-BESTest (Mini-Balance Evaluation Systems Test), Berg Balance Scale and Timed Up and Go Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Sep 2020to 30 Dec 2020
- 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
- Chronic stroke patients
- Patients who can execute commands
- Patients who are ambulatory enough to complete most balance tasks
- Patients participating in the study voluntarily
Who cannot join
- Acute stroke patients
- Patients who cannot execute commands
- Non-ambulatory patients
- Pediatric patients and pregnant patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department
Istanbul, 34732
Bilinç Doğruöz Karatekin, +905368308709, bilincdogruoz@hotmail.com
Bilinç Doğruöz Karatekin, MD
About this study
"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.
Read the 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.
- Conditions
- Stroke, Balance; Distorted
- Being tested
- mini-BESTest (Mini-Balance Evaluation Systems Test), Berg Balance Scale, Timed Up and Go Test, Functional Reach Test
- Keywords
- balance, stroke, validity, reliability
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mini-BESTest (Mini-Balance Evaluation Systems Test)Diagnostic test
Balance evaluation test that has 14 tasks leading to a total possible score of 28 points requires only 10 to 15 minutes to conduct.
Berg Balance ScaleDiagnostic test
The scale is a 14-item objective measure designed to assess static balance and fall risk in adult populations.
Timed Up and Go TestDiagnostic test
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.
Functional Reach TestDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Stroke | Experimental | Stroke patients who applied to the Physical Medicine and Rehabilitation outpatient clinic, met the inclusion criteria and volunteered to participate in the study Receives: Diagnostic Test: mini-BESTest (Mini-Balance Evaluation Systems Test); Diagnostic Test: Berg Balance Scale; Diagnostic Test: Timed Up and Go Test; Diagnostic Test: Functional Reach Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
mini-BESTest
Balance evaluation test that has 14 tasks leading to a total possible score of 28 points.
Measured: 3 months
Berg Balance Scale
The scale is a 14-item objective measure designed to assess static balance and fall risk in adult populations
Measured: 3 months
Timed Up and Go Test
It is a test used to assess a person's mobility and requires both static and dynamic balance
Measured: 3 months
Functional Reach Test
The Functional Reach Test is a single item test developed as a quick screen for balance problems in older adults
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start24 Sep 2020
- Primary completion24 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
- Investigators
- Bilinç Karatekin, Principal investigator, Istanbul Medeniyet University Physical Therapy And Rehabilitation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568070
- Sponsor's protocol ID
- IMU Stroke
- Status last verified
- Sep 2020
- First submitted
- 24 Sep 2020
- Last updated
- 29 Sep 2020
- 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 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Version of the Mini-BESTest: Transcultural Adaptation and Validation Study in Stroke Patients
- ClinicalTrials.gov ID
- NCT04568070
- Acronym / sponsor ID
- IMU Stroke
- Conditions
- Stroke, Balance; Distorted
- Keywords
- balance, stroke, validity, reliability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 24 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 29 Sep 2020 (actual)
- 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.
"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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke | Experimental | Diagnostic Test: mini-BESTest (Mini-Balance Evaluation Systems Test), Diagnostic Test: Berg Balance Scale, Diagnostic Test: Timed Up and Go Test, Diagnostic Test: Functional Reach TestStroke patients who applied to the Physical Medicine and Rehabilitation outpatient clinic, met the inclusion criteria and volunteered to participate in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic stroke patients
- Patients who can execute commands
- Patients who are ambulatory enough to complete most balance tasks
- Patients participating in the study voluntarily
Key exclusion criteria (4 listed)
- Acute stroke patients
- Patients who cannot execute commands
- Non-ambulatory patients
- Pediatric patients and pregnant patients
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 |
|---|---|---|
| mini-BESTest (Mini-Balance Evaluation Systems Test)Balance evaluation test that has 14 tasks leading to a total possible score of 28 points requires only 10 to 15 minutes to conduct. | Diagnostic test | Stroke |
| Berg Balance ScaleThe scale is a 14-item objective measure designed to assess static balance and fall risk in adult populations. | Diagnostic test | Stroke |
| Timed Up and Go TestIt 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. | Diagnostic test | Stroke |
| Functional Reach TestThe 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. | Diagnostic test | Stroke |
Primary outcome
mini-BESTest
Time frame: 3 months
Balance evaluation test that has 14 tasks leading to a total possible score of 28 points.
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Bilinç Karatekin principal investigator
Istanbul Medeniyet University Physical Therapy And Rehabilitation Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mini-BESTest (Mini-Balance Evaluation Systems Test), Berg Balance Scale and Timed Up and Go Test in people with Stroke and Balance; Distorted, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Sep 2020. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bilinç Karatekin (+905368308709, bilincdogruoz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mini-BESTest (time frame: 3 months). The study lists 4 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 29 Sep 2020.