NCT05823298

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

December 15, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

April 9, 2023

Last Update Submit

April 28, 2026

Conditions

Keywords

fugl-meyer assessmentupper extremitylower extremityoutcome assessmentstroke rehabilitationtranslation and cross-cultural adaptationvalidityreliabilitystrokehemiplegia

Outcome Measures

Primary Outcomes (3)

  • Barthel Index

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

    5 minutes

  • Modified Rankin Scale

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

    5 minutes

  • Fugl-Meyer Assessment (Upper and Lower Extremity Form)

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

    45 minutes

Secondary Outcomes (1)

  • Berg Balance Scale

    10 minutes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstinye University Brain Angiography Stroke Center

Istanbul, Esenyurt, 34510, Turkey (Türkiye)

Location

Related Publications (16)

  • 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.

    PMID: 21566236BACKGROUND
  • 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.

    PMID: 11124735BACKGROUND
  • 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.

    PMID: 26515205BACKGROUND
  • 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.

    PMID: 3969398BACKGROUND
  • 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.

    PMID: 16980142BACKGROUND
  • 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.

    PMID: 2947907BACKGROUND
  • 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.

    PMID: 6622535BACKGROUND
  • 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.

    PMID: 1135616BACKGROUND
  • 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.

    PMID: 12234086BACKGROUND
  • 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.

    PMID: 7979930BACKGROUND
  • 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.

    PMID: 10381238BACKGROUND
  • 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.

    PMID: 25880033BACKGROUND
  • 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.

    PMID: 15824050BACKGROUND
  • 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.

    PMID: 23774125BACKGROUND
  • 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.

    PMID: 17161752BACKGROUND
  • 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.

    PMID: 3335877BACKGROUND

Related Links

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lide Z Uz, 1

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 9, 2023

First Posted

April 21, 2023

Study Start

December 15, 2023

Primary Completion

August 15, 2024

Study Completion

December 1, 2024

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations