NCT04268446

Brief Summary

The aim of this study is to investigate the validity and reliability of the Turkish version of the brief-BESTest (short BESTest) scale in stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 29, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

1.2 years

First QC Date

February 11, 2020

Last Update Submit

November 5, 2020

Conditions

Keywords

brief BESTeststroke patientsTurkish version

Outcome Measures

Primary Outcomes (5)

  • Berg Balance Test

    It is a 14-item scale that evaluates the tasks used in daily life activities.Standing up without support, standing without support, sitting without support, standing up, transfers, standing with feet, standing with legs while standing, reaching out while standing, picking up from the ground, looking back, 360 degree rotation, firm side standing on the stool, one foot standstill and standstill functions are evaluated.Each item is planned between 0-4; 0 is unable to fulfill the task, 4 is to fulfill the task successfully. The total score of the test is between 0-56.0-20 points: wheelchair dependent, 21-40: assisted walking, 41-56: means independent ambulation.

    15 minutes

  • Functional Reach Test

    Subjects will asked to stand comfortably, to make a fist, and to raise their arm until it was parallel to the yardstick (position 1). The placement of the end of the third metacarpal along the yardstick will recorded. Subjects will then asked to reach as far forward as they could without losing their balance (position 2), and the position of the end of the third metacarpal along the yardstick will again recorded. No attempt will make to control the subject's method of reach, but if he will touch the wall or took a step during the maneuver, that trial will consider invalid and repeated.

    5 minutes

  • Time Up and Go Test

    This test is applied to assess the risk of falling and mobility.This test starts with the individual leaving the chair without receiving arm support by giving the go command while sitting in a chair.The distance of 3 meters is asked to return and sit again in the chair.The elapsed time is recorded in seconds.

    5 minutes

  • 10 Meter Walk Tests

    Walking speed are measure by timing subjects over 10 meters with a stopwatch. To avoid the effects of acceleration and deceleration, measurements take over the middle 10 meters of a 14-meter walkway. It is repeated 2 times.

    3 minutes

  • Falls Efficacy Scale

    FES is a 10-item scale and these items are; To enter and get out of bed, to sit and stand on the chair, to take a bath or shower, to dress and undress, to lie on the shelves, to walk in the house, to answer the door or phone, to prepare food without lifting heavy objects and to do simple shopping. Individuals score between 0 (not safe) and 10 (very safe) for each question, and when all scores are summed, a total score between 0 and 100 is obtained.

    5 minutes

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who are able to walk 10 m independently with or without a device over 40 years old with a diagnosis of stroke.

You may qualify if:

  • Being 40 years old or older,
  • Diagnosis of stroke,
  • No cooperation and communication problems
  • To be able to walk 10 m independently with or without an auxiliary device

You may not qualify if:

  • Another neurological or orthopedic problem other than stroke that will affect functionality and balance
  • Individuals with advanced contraindications for cardiovascular disease and mobilization will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale University

Kırıkkale, 71000, Turkey (Türkiye)

Location

Related Publications (8)

  • Padgett PK, Jacobs JV, Kasser SL. Is the BESTest at its best? A suggested brief version based on interrater reliability, validity, internal consistency, and theoretical construct. Phys Ther. 2012 Sep;92(9):1197-207. doi: 10.2522/ptj.20120056. Epub 2012 Jun 7.

    PMID: 22677295BACKGROUND
  • Smith PS, Hembree JA, Thompson ME. Berg Balance Scale and Functional Reach: determining the best clinical tool for individuals post acute stroke. Clin Rehabil. 2004 Nov;18(7):811-8. doi: 10.1191/0269215504cr817oa.

    PMID: 15573838BACKGROUND
  • Schmidt S, Bullinger M. Current issues in cross-cultural quality of life instrument development. Arch Phys Med Rehabil. 2003 Apr;84(4 Suppl 2):S29-34. doi: 10.1053/apmr.2003.50244.

    PMID: 12692769BACKGROUND
  • Chinsongkram B, Chaikeeree N, Saengsirisuwan V, Viriyatharakij N, Horak FB, Boonsinsukh R. Reliability and validity of the Balance Evaluation Systems Test (BESTest) in people with subacute stroke. Phys Ther. 2014 Nov;94(11):1632-43. doi: 10.2522/ptj.20130558. Epub 2014 Jun 12.

    PMID: 24925073BACKGROUND
  • Bergstrom M, Lenholm E, Franzen E. Translation and validation of the Swedish version of the mini-BESTest in subjects with Parkinson's disease or stroke: a pilot study. Physiother Theory Pract. 2012 Oct;28(7):509-14. doi: 10.3109/09593985.2011.653707. Epub 2012 Jan 30.

    PMID: 22288658BACKGROUND
  • O'Hoski S, Sibley KM, Brooks D, Beauchamp MK. Construct validity of the BESTest, mini-BESTest and briefBESTest in adults aged 50 years and older. Gait Posture. 2015 Sep;42(3):301-5. doi: 10.1016/j.gaitpost.2015.06.006. Epub 2015 Jun 25.

    PMID: 26183191BACKGROUND
  • Franchignoni F, Horak F, Godi M, Nardone A, Giordano A. Using psychometric techniques to improve the Balance Evaluation Systems Test: the mini-BESTest. J Rehabil Med. 2010 Apr;42(4):323-31. doi: 10.2340/16501977-0537.

    PMID: 20461334BACKGROUND
  • Horak FB, Wrisley DM, Frank J. The Balance Evaluation Systems Test (BESTest) to differentiate balance deficits. Phys Ther. 2009 May;89(5):484-98. doi: 10.2522/ptj.20080071. Epub 2009 Mar 27.

    PMID: 19329772BACKGROUND

Study Officials

  • Saniye Aydoğan Arslan

    Kırıkkale University

    STUDY DIRECTOR
  • Kübra Uğurlu

    Kırıkkale University

    PRINCIPAL INVESTIGATOR
  • Cevher Demirci

    Balikesir University

    PRINCIPAL INVESTIGATOR
  • Zekiye İpek Katırcı Kırmacı

    Sanko University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 13, 2020

Study Start

March 29, 2019

Primary Completion

May 30, 2020

Study Completion

June 30, 2020

Last Updated

November 6, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations