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Stroke PatientsNCT04268446

Turkish Version of the Brief-BESTest Scale

An observational study of Stroke Patients, run by Kırıkkale University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Stroke Patients
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
29 Mar 2019to 30 Jun 2020
Phase
Observational
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Kırıkkale University

    Kirikkale, 71000

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Turkish Version, Validity and Reliability of Brief-BESTest Scale in Stroke Patients

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.

Read the detailed description

Brief Balance Evaluation Systems Test (Brief-BESTest) is a short version of the Balance evaluation systems test (BESTest). Balance assessment systems test (BESTest) The balance assessment systems test developed by Horak consists of 6 sub-sections that evaluate the systems related to balance; 1) biomechanical limitations, 2) stability limit, 3) postural responses, 4) intuitive postural adjustments, 5) sensory orientation and 6) walking. It consists of 36 tests in total. Each question is rated between 0-3. The highest score that can be obtained is 108. Low test scores show that the balance is disturbed. BESTest has been found to be reliable among raters evaluating a cohort of individuals with and without various neurological diagnoses. In studies conducted, it was stated that BESTest is reliable when compared to other scales evaluating balance.

The necessary permissions have been obtained from the authors for Short BESTest, whose validity and reliability features will be tested, and the translation process to Turkish has been completed and the survey has been finalized. The basis for the use of special tools such as the scale is to prove the usability of the tool in the sample group to which it will be applied. The first step for this is the translation stage from the original language to the other language.

At the stage of translation into Turkish, two experts who knew a good level of English translated the questionnaire from English into Turkish. These translations have been translated back into Turkish by two native speakers of English and distant medical subjects. In addition, these translations were re-examined by the researchers and turned into a single form. This form was sent to five specialists in the field, checking the content and compliance with Turkish was evaluated. With the opinion of experts, the scale was finalized.

The study will include individuals over 40 years of age who have been diagnosed with an ischemic or hemorhagic stroke, who applied to the Kırıkkale University Faculty of Medicine Physical Therapy and Rehabilitation Hospital.

Conditions
Stroke Patients
Keywords
brief BESTest, stroke patients, Turkish version

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 15 minutes

  2. 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.

    Measured: 5 minutes

  3. 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.

    Measured: 5 minutes

  4. 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.

    Measured: 3 minutes

  5. 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.

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2020
  2. Study start29 Mar 2019
  3. Primary completion30 May 2020
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04268446
Sponsor's protocol ID
turkishbriefBESTest
Status last verified
Nov 2020
First submitted
11 Feb 2020
Last updated
6 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22677295

  • 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.

    PubMed 15573838

  • 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.

    PubMed 12692769

  • 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.

    PubMed 24925073

  • 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.

    PubMed 22288658

  • 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.

    PubMed 26183191

  • 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.

    PubMed 20461334

  • 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.

    PubMed 19329772

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke Patients, run by Kırıkkale 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 2 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: finished, as of the sponsor's last update on 6 Nov 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Berg Balance Test (time frame: 15 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04268446, which also lists 8 linked publications.

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 6 Nov 2020.

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