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Turkish Version of the Mini-BESTest: Transcultural Adaptation and Validation Study in Stroke Patients

Primary Purpose

Stroke, Balance; Distorted

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

mini-BESTest (Mini-Balance Evaluation Systems Test)

Berg Balance Scale

Timed Up and Go Test

Functional Reach Test

About this trial

This is an interventional diagnostic trial for Stroke focused on measuring balance, stroke, validity, reliability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation DepartmentRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stroke

Arm Description

Stroke patients who applied to the Physical Medicine and Rehabilitation outpatient clinic, met the inclusion criteria and volunteered to participate in the study

Outcomes

Primary Outcome Measures

mini-BESTest

Balance evaluation test that has 14 tasks leading to a total possible score of 28 points.

Berg Balance Scale

The scale is a 14-item objective measure designed to assess static balance and fall risk in adult populations

Timed Up and Go Test

It is a test used to assess a person's mobility and requires both static and dynamic balance

Functional Reach Test

The Functional Reach Test is a single item test developed as a quick screen for balance problems in older adults

Secondary Outcome Measures

Full Information

NCT ID

NCT04568070

First Posted

September 24, 2020

Last Updated

September 28, 2020

Sponsor

Istanbul Medeniyet University

1. Study Identification

Unique Protocol Identification Number

NCT04568070

Brief Title

Turkish Version of the Mini-BESTest: Transcultural Adaptation and Validation Study in Stroke Patients

Official Title

Turkish Version of the Mini-BESTest: Transcultural Adaptation and Validation Study in Stroke Patients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 24, 2020 (Actual)

Primary Completion Date

December 24, 2020 (Anticipated)

Study Completion Date

December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istanbul Medeniyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Balance; Distorted

Keywords

balance, stroke, validity, reliability

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stroke

Arm Type

Experimental

Arm Description

Stroke patients who applied to the Physical Medicine and Rehabilitation outpatient clinic, met the inclusion criteria and volunteered to participate in the study

Intervention Type

Diagnostic Test

Intervention Name(s)

mini-BESTest (Mini-Balance Evaluation Systems Test)

Intervention Description

Balance evaluation test that has 14 tasks leading to a total possible score of 28 points requires only 10 to 15 minutes to conduct.

Intervention Type

Diagnostic Test

Intervention Name(s)

Berg Balance Scale

Intervention Description

The scale is a 14-item objective measure designed to assess static balance and fall risk in adult populations.

Intervention Type

Diagnostic Test

Intervention Name(s)

Timed Up and Go Test

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Functional Reach Test

Intervention Description

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.

Primary Outcome Measure Information:

Title

mini-BESTest

Description

Balance evaluation test that has 14 tasks leading to a total possible score of 28 points.

Time Frame

3 months

Title

Berg Balance Scale

Description

The scale is a 14-item objective measure designed to assess static balance and fall risk in adult populations

Time Frame

3 months

Title

Timed Up and Go Test

Description

It is a test used to assess a person's mobility and requires both static and dynamic balance

Time Frame

3 months

Title

Functional Reach Test

Description

The Functional Reach Test is a single item test developed as a quick screen for balance problems in older adults

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bilinç Karatekin

Phone

+905368308709

bilincdogruoz@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Afitap Icagasioglu

Phone

+905324129373

afitapi@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bilinç Karatekin

Organizational Affiliation

Istanbul Medeniyet University Physical Therapy And Rehabilitation Department

Official's Role

Principal Investigator

Facility Information:

Facility Name

Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department

City

Istanbul

ZIP/Postal Code

34732

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bilinç Doğruöz Karatekin

Phone

+905368308709

bilincdogruoz@hotmail.com

First Name & Middle Initial & Last Name & Degree

Bilinç Doğruöz Karatekin, MD

First Name & Middle Initial & Last Name & Degree

Afitap Icagasioglu, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Turkish Version of the Mini-BESTest: Transcultural Adaptation and Validation Study in Stroke Patients

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