Stroke Clinical Trial
— F-ArmAOfficial title:
Translation and Transcultural Adaptation of the Arm Activity Measure (ArmA) and Motor Activity Log (MAL) to Assess Perceived Performance of the Upper Limb Use in Adults With Subacute and Chronic Stroke. F-ArmA
Verified date | February 2021 |
Source | University Hospital, Toulouse |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Upper limb impairment occurs in approximately 70 to 80 per cent of adults post stroke. These impairments will have consequences on functional performance in activities of daily living and hence quality of life. Assessment of upper limb function is a component of rehabilitation that contributes to the selection of optimal interventions according to patient individualized needs. The Arm Activity Measure (ArmA) provides a standardized assessment of upper limb passive and active perceived performance that is only available in it's English version. The aim of this study is to translate and conduct a cross-cultural adaptation of the ArmA is order to investigate its psychometric properties through a validation study among stroke patients.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | February 9, 2023 |
Est. primary completion date | February 9, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age > 18 with principle diagnosis of first-time ischemic or hemorrhagic stroke at least 7 days since onset and confirmed by MRI or CT; - participant having returned home from hospitalization at least one night if stroke time since onset is <6 months or resides at home if >6 months since stroke onset; - participant can maintain attention for questions for at least 30 minutes; - motivation to participate and having given informed written consent. Exclusion Criteria: - subscale of aphasia severity from the Boston Diagnostic Aphasia Examination =3 indicating insufficient comprehension and expression for testing; - subscale score of =2 on the agnosia Unilateral Negligence Assessment Battery (BEN) indicating unilateral neglect. |
Country | Name | City | State |
---|---|---|---|
France | UHToulouse | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measure OF ArmA inter-rater (test-retest) reproducibility values as measured by intra class coefficients ICC2 | The primary outcome measure will be ArmA inter-rater (test-retest) reproducibility values as measured by intra class coefficients ICC2,1. Data collection on perceived upper limb performance with the two-step F-ArmA measurement (T0 and T1) will allow the primary outcome (ICC2,1) to be calculated to establish inter-rater reproducibility. ArmA and MAL will be administered on 3 separate occasions by 2 separate assessors. |
first day of hospitalisation | |
Primary | Measure OF ArmA inter-rater (test-retest) reproducibility values as measured by intra class coefficients ICC2 | A secondary independent assessor (E2) will assess ArmA and MAL | 2 to 7 days of first assessment (T0) |
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