NCT04568070

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2020

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

September 24, 2020

Last Update Submit

September 28, 2020

Conditions

StrokeBalance; Distorted

Keywords

balancestrokevalidityreliability

Outcome Measures

Primary Outcomes (4)

  • mini-BESTest

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

    3 months

  • Berg Balance Scale

    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

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

    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

    3 months

Study Arms (1)

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

Diagnostic Test: mini-BESTest (Mini-Balance Evaluation Systems Test)Diagnostic Test: Berg Balance ScaleDiagnostic Test: Timed Up and Go TestDiagnostic Test: Functional Reach Test

Interventions

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.

Stroke
Berg Balance ScaleDIAGNOSTIC_TEST

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

Stroke
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.

Stroke
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.

Stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic stroke patients
  • Patients who can execute commands
  • Patients who are ambulatory enough to complete most balance tasks
  • Patients participating in the study voluntarily

You may not qualify if:

  • Acute stroke patients
  • Patients who cannot execute commands
  • Non-ambulatory patients
  • Pediatric patients and pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Istanbul, 34732, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bilinç Karatekin

    Istanbul Medeniyet University Physical Therapy And Rehabilitation Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bilinç Karatekin

CONTACT

+905368308709bilincdogruoz@hotmail.com

Afitap Icagasioglu

CONTACT

+905324129373afitapi@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 24, 2020

First Posted

September 29, 2020

Study Start

September 24, 2020

Primary Completion

December 24, 2020

Study Completion

December 30, 2020

Last Updated

September 29, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)