Clinical trial NCT05823298: Turkish Adaptation and Psychometric Properties of Fugl-Meyer Assessment in Acute Stroke Patients
Official title: Cultural Adaptation of Fugl-Meyer Assessment to Turkish and Evaluation of Psychometric Properties in Acute Stroke Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Acute
Cerebrovascular; Disorder, Acute
Keywords: acute stroke
fugl-meyer assessment
upper extremity
lower extremity
outcome assessment
stroke rehabilitation
translation and cross-cultural adaptation
validity
reliability
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients who were hospitalized in Istinye University Liv Hospital Brain Angiography Stroke Center between May 2023 to December 2023.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients who diagnosed with stroke
* Less than 1 month passed after onset of stroke
* Upper and lower extremity motor involvement between Brunnstrom stages 2 and 5
* Voluntarily accepting to participate in this research

Exclusion Criteria:

* Visual and hearing impairment
* Upper or lower extremity amputation
* Significant cognitive impairment (Mini Mental State Test Score \< 18)
* Mental disorders affecting daily life functioning
* Global aphasia
* Other unstable conditions that may affect participation

Primary outcomes:
measure: Barthel Index
timeFrame: 5 minutes
measure: Modified Rankin Scale
timeFrame: 5 minutes
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstinye University Brain Angiography Stroke Center
state: Esenyurt
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Lide Z Uz, 1
role: PRINCIPAL_INVESTIGATOR
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