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AzTrials

StrokeFMA-TRNCT05823298

Translation And Psychometric Testing Of The Turkish Version Of Fugl-Meyer Assessment

An observational study of Stroke and CVA (Cerebrovascular Accident), run by Istanbul University - Cerrahpasa 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 methodological study is to adapt the Fugl-Meyer assessment to Turkish culture and to test its validity and reliability in acute phase stroke patients. Read more about this study

Who is it for?
Ages 18 years and older
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Dec 2023to 1 Dec 2024
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Stroke patients who were hospitalized in Istinye University Liv Hospital Brain Angiography Stroke Center between May 2023 to December 2023.

Who may be able to join

  • Age ≥18 years
  • Hemiparesis or hemiplegia due to ischemic or hemorrhagic stroke within the previous 8 - weeks

Who cannot join

  • Visual or hearing impairment
  • Upper or lower extremity amputation
  • MMSE score ≤21
  • Global aphasia or psychiatric disorder affecting daily life and participation
  • Any unstable medical condition affecting participation

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • İstinye University Liv Hospital Stroke Center

    Istanbul, Esenyurt, 34517

Other trials in Turkey (Türkiye)

About this study

Official title: Translation And Psychometric Evaluation Of The Turkish Fugl-Meyer Assessment For Upper And Lower Extremities

The aim of this methodological study is to adapt the Fugl-Meyer assessment to Turkish culture and to test its validity and reliability in acute phase stroke patients.

Read the detailed description

According to the definition of the World Health Organization, stroke is a clinical syndrome that causes rapid focal (or global) cerebral function loss for no apparent reason other than vascular causes, and symptoms persist for more than 24 hours or lead to death.

To effectively manage the post-stroke processes and establish an effective treatment plan, a comprehensive assessment is necessary. One of the most common motor problems following a stroke is hemiplegia, which makes it challenging for the patient to perform activities of daily living and ambulation. Understanding the mechanisms of motor control and motor learning, which are vital components of stroke rehabilitation, necessitates the assessment of motor function. For evaluating motor function in stroke patients, there are numerous outcome measures available. The Fugl-Meyer Assessment (FMA) stands out when comparison of these assessments in terms of clinical and psychometric values. There is no official FMA version that has been translated into Turkish, even though Fugl-Meyer assessment is used in numerous research in Turkey. The aim of this study is to adapt the Fugl-Meyer assessment to Turkish culture and to test its validity and reliability in acute stroke patients.

Keywords
fugl-meyer assessment, upper extremity, lower extremity, outcome assessment, stroke rehabilitation, translation and cross-cultural adaptation, validity, reliability, stroke, hemiplegia
Medical subject headings
Stroke, Hemiplegia

What is being measured

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

  1. Fugl-Meyer Assessment (Upper and Lower Extremity Form)

    a 3 point ordinal scale that evaluates sensorimotor function, coordination, pROM and pain

    Measured: 45 minutes

  2. Barthel Index

    a scale used to assess functional independence. Points ranging from 0 to 100.

    Measured: 5 minutes

  3. Modified Rankin Scale

    a 6 point disability scale with possible scores ranging from 0 to 5

    Measured: 5 minutes

Secondary outcomes (1)

  1. Berg Balance Scale

    a scale to measure balance in older adults with scores ranging from 0 to 56

    Measured: 10 minutes

Timeline

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

  1. First posted21 Apr 2023
  2. Study start15 Dec 2023
  3. Primary completion15 Aug 2024
  4. Study completion1 Dec 2024

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
Case only
Time perspective
Prospective
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05823298
Sponsor's protocol ID
FMA TURKISH VERSION
Acronym
FMA-TR
Status last verified
May 2026
First submitted
9 Apr 2023
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Baker K, Cano SJ, Playford ED. Outcome measurement in stroke: a scale selection strategy. Stroke. 2011 Jun;42(6):1787-94. doi: 10.1161/STROKEAHA.110.608505. Epub 2011 May 12.

    PubMed 21566236

  • Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.

    PubMed 11124735

  • Bushnell C, Bettger JP, Cockroft KM, Cramer SC, Edelen MO, Hanley D, Katzan IL, Mattke S, Nilsen DM, Piquado T, Skidmore ER, Wing K, Yenokyan G. Chronic Stroke Outcome Measures for Motor Function Intervention Trials: Expert Panel Recommendations. Circ Cardiovasc Qual Outcomes. 2015 Oct;8(6 Suppl 3):S163-9. doi: 10.1161/CIRCOUTCOMES.115.002098.

    PubMed 26515205

  • Carr JH, Shepherd RB, Nordholm L, Lynne D. Investigation of a new motor assessment scale for stroke patients. Phys Ther. 1985 Feb;65(2):175-80. doi: 10.1093/ptj/65.2.175.

    PubMed 3969398

  • de Vet HC, Terwee CB, Knol DL, Bouter LM. When to use agreement versus reliability measures. J Clin Epidemiol. 2006 Oct;59(10):1033-9. doi: 10.1016/j.jclinepi.2005.10.015. Epub 2006 Aug 10.

    PubMed 16980142

  • Deyo RA, Centor RM. Assessing the responsiveness of functional scales to clinical change: an analogy to diagnostic test performance. J Chronic Dis. 1986;39(11):897-906. doi: 10.1016/0021-9681(86)90038-x.

    PubMed 2947907

  • Duncan PW, Propst M, Nelson SG. Reliability of the Fugl-Meyer assessment of sensorimotor recovery following cerebrovascular accident. Phys Ther. 1983 Oct;63(10):1606-10. doi: 10.1093/ptj/63.10.1606.

    PubMed 6622535

  • Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.

    PubMed 1135616

  • Gladstone DJ, Danells CJ, Black SE. The fugl-meyer assessment of motor recovery after stroke: a critical review of its measurement properties. Neurorehabil Neural Repair. 2002 Sep;16(3):232-40. doi: 10.1177/154596802401105171.

    PubMed 12234086

  • Malouin F, Pichard L, Bonneau C, Durand A, Corriveau D. Evaluating motor recovery early after stroke: comparison of the Fugl-Meyer Assessment and the Motor Assessment Scale. Arch Phys Med Rehabil. 1994 Nov;75(11):1206-12. doi: 10.1016/0003-9993(94)90006-x.

    PubMed 7979930

  • Mayo NE, Wood-Dauphinee S, Ahmed S, Gordon C, Higgins J, McEwen S, Salbach N. Disablement following stroke. Disabil Rehabil. 1999 May-Jun;21(5-6):258-68. doi: 10.1080/096382899297684.

    PubMed 10381238

  • Alt Murphy M, Resteghini C, Feys P, Lamers I. An overview of systematic reviews on upper extremity outcome measures after stroke. BMC Neurol. 2015 Mar 11;15:29. doi: 10.1186/s12883-015-0292-6.

    PubMed 25880033

  • Salter K, Jutai JW, Teasell R, Foley NC, Bitensky J. Issues for selection of outcome measures in stroke rehabilitation: ICF Body Functions. Disabil Rehabil. 2005 Feb 18;27(4):191-207. doi: 10.1080/09638280400008537.

    PubMed 15824050

  • See J, Dodakian L, Chou C, Chan V, McKenzie A, Reinkensmeyer DJ, Cramer SC. A standardized approach to the Fugl-Meyer assessment and its implications for clinical trials. Neurorehabil Neural Repair. 2013 Oct;27(8):732-41. doi: 10.1177/1545968313491000. Epub 2013 Jun 17.

    PubMed 23774125

  • Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24.

    PubMed 17161752

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and CVA (Cerebrovascular Accident), run by Istanbul University - Cerrahpasa 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 2 inclusion and 5 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 7 May 2026. 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?

Fugl-Meyer Assessment (Upper and Lower Extremity Form) (time frame: 45 minutes). The study lists 3 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 NCT05823298, which also lists 16 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 7 May 2026.

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