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NCT05823298 Clinical Trial

Turkish Adaptation and Psychometric Properties of Fugl-Meyer Assessment in Acute Stroke Patients

Stroke, Acute Clinical Trial

— FMD  

Official title:
Cultural Adaptation of Fugl-Meyer Assessment to Turkish and Evaluation of Psychometric Properties in Acute Stroke Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05823298
Other study ID # FMA Acute Stroke
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 15, 2023
Est. completion date June 1, 2024

Study information
Verified date January 2024
Source Istanbul University - Cerrahpasa (IUC)
Contact Lide Z Uz, 1
Phone 5313134380
Email lide.uz@ogr.iuc.edu.tr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date June 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Istinye University Brain Angiography Stroke Center Istanbul Esenyurt

Sponsors (1)
Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

The World Health Organization MONICA Project (monitoring trends and determinants in cardiovascular disease): a major international collaboration. WHO MONICA Project Principal Investigators. J Clin Epidemiol. 1988;41(2):105-14. doi: 10.1016/0895-4356(88)90084-4. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary Barthel Index a scale used to assess functional independence. Points ranging from 0 to 100. 5 minutes
Primary Modified Rankin Scale a 6 point disability scale with possible scores ranging from 0 to 5 5 minutes
Secondary Berg Balance Scale a scale to measure balance in older adults with scores ranging from 0 to 56 10 minutes
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