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Completed

NCT Number: NCT05823298

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

İstinye University Liv Hospital Stroke Center

Istanbul, Esenyurt, 34517, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: 45 minutes

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

  2. Barthel Index

    Time frame: 5 minutes

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

  3. Modified Rankin Scale

    Time frame: 5 minutes

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

Secondary outcomes

  1. Berg Balance Scale

    Time frame: 10 minutes

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

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Acronym: FMA-TR

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 21, 2023
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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