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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Arm Activity Measure (ArmA) in french

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31000
    • UHToulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

adults with subacute and chronic stroke

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
subacute phase; between 7 days and 6 months post-stroke;	Other: Arm Activity Measure (ArmA) in french; The Arm Activity Measure (ArmA) provides a standardized assessment of upper limb passive and active perceived performance
chronic phase; minimum 6 months post-stroke	Other: Arm Activity Measure (ArmA) in french; The Arm Activity Measure (ArmA) provides a standardized assessment of upper limb passive and active perceived performance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Claire VILLEPINTE, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 9, 2021
• Primary Completion (ACTUAL): February 9, 2021
• Study Completion (ANTICIPATED): February 9, 2023

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (ACTUAL): February 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: RC31/19/0209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No