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

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ClinicalTrials.gov Identifier: NCT04754555
Recruitment Status : Active, not recruiting
First Posted : February 15, 2021
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment
Stroke 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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official 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
Actual Study Start Date : February 9, 2021
Actual Primary Completion Date : February 9, 2021
Estimated Study Completion Date : February 9, 2023

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




Primary Outcome Measures :
  1. Measure OF ArmA inter-rater (test-retest) reproducibility values as measured by intra class coefficients ICC2 [ Time Frame: first day of hospitalisation ]

    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.


  2. Measure OF ArmA inter-rater (test-retest) reproducibility values as measured by intra class coefficients ICC2 [ Time Frame: 2 to 7 days of first assessment (T0) ]
    A secondary independent assessor (E2) will assess ArmA and MAL



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adults with subacute and chronic stroke
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04754555


Locations
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France
UHToulouse
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Claire VILLEPINTE University Hospital, Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04754555    
Other Study ID Numbers: RC31/19/0209
First Posted: February 15, 2021    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases