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

NCT ID: NCT04754555

Last Updated: 2021-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-09
• Study Completion Date: 2023-02-09

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.

Detailed Description

Assessment of the upper limb post-stroke should be standardized and holistic, representative of multidimensional consequences according the International Classification of Function and Disability (CIF). Measures should demonstrate established psychometric properties, in terms of validity, reproducibility and responsiveness to change. The ArmA allows standardized measurement of both passive and active functions of the upper limb in terms of perceived performance under the activity level of the CIF. To date there is no measure that allows assessment of both upper limb functions of perceived performance in the French language.

Prior to this study, a translation and cross-cultural adaptation (TCCA) of the ArmA was performed in accordance with study objectives and identified gap in the literature. TCCA was conducted in accordance with guidelines for subjective outcome measures contributing to evidence-based practice (Beaton et al., 2000). A six-step translation procedure for self-reported outcome measures was relevant of clinical use in a foreign language. A multidisciplinary team ensured a forwards-backwards translation and cross-cultural adaptation.

An observational, single-center, cross-sectional study design will be implemented to determine the psychometric properties of the French ArmA.

Participants will be from a post-stroke rehabilitation service (as part of their usual care). For the analysis of reliability properties, participants will be hospitalized as part of routine care and participation in the protocol (T0, T1 and T2 assessments) will add 1 to 2 hours of assessment to routine care.

Assessors will be trained Occupational Therapists having participated in the development of the measure.

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

subacute phase

between 7 days and 6 months post-stroke;

Arm Activity Measure (ArmA) in french

Intervention Type: OTHER

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

chronic phase

minimum 6 months post-stroke

Arm Activity Measure (ArmA) in french

Intervention Type: OTHER

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

Interventions

Arm Activity Measure (ArmA) in french

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claire VILLEPINTE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

UHToulouse

Toulouse, , France

Countries

France

Other Identifiers

RC31/19/0209

Identifier Type: -

Identifier Source: org_study_id