Translation and Transcultural Adaptation of the Arm Activity Measure (ArmA) and Motor Activity Log (MAL)

NCT04754555 | Unknown

• 1 other identifier: RC31/19/0209
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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

• 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)

Study Arms (2)

subacute phase

between 7 days and 6 months post-stroke;

Other: Arm Activity Measure (ArmA) in french

chronic phase

minimum 6 months post-stroke

Other: Arm Activity Measure (ArmA) in french

Interventions

Arm Activity Measure (ArmA) in french OTHER

The Arm Activity Measure (ArmA) provides a standardized assessment of upper limb passive and active perceived performance

chronic phase; subacute phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

adults with subacute and chronic stroke

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

UHToulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Claire VILLEPINTE

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 15, 2021
• Study Start: February 9, 2021
• Primary Completion: February 9, 2021
• Study Completion: February 9, 2023
• Last Updated: February 15, 2021

Record last verified: 2021-02

Locations

FR (1)