Validation of a Self-questionnaire in French on the Use of the Upper Limbs in Patients With Multiple Sclerosis

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Validation of AMSQ questionnaire

• Registration Number: NCT03655093
• Lead Sponsor: Rennes University Hospital

Brief Summary

Multiple sclerosis (MS) is an inflammatory and demyelinating disease of the central nervous system that causes disability in young adults. This disability can take many forms depending on the neurological systems affected: disability walking, cognitive impairment or disability in the upper limbs. The development of validated measurement tools for these different disabilities is essential for the follow-up of patients in clinical routine and for the evaluation of new therapies.

Detailed Description

A specific self-questionnaire for patients with MS has recently been developed and validated in English and Dutch: "The Arm Function in Multiple Sclerosis Questionnaire (AMSQ)". The questionnaire groups 31 items and was created from questionnaires developed for other pathologies. The Dutch team that developed this questionnaire combines biostatisticians and neurologists, experts in the development and validation of disability measurement tools.

This study aims to validate the French version of AMSQ questionnaire. This study is carried out in collaboration with the Amsterdam team, which has carried out the methodology and will conduct the statistical analysis.

Study Timeline

• Study Start: 2017-04-25
• Primary Completion: 2017-07-03
• Study Completion: 2017-07-03
• Status Verified: 2018-08
• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2018-08-29
• Last Update Submitted: 2018-08-29
• Study First Posted: 2018-08-31
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patient with MS according to the diagnostic criteria of 2010
• Age ≥18 years
• Patients seen in consultation at the SEP reference center in Rennes

Exclusion Criteria

• Other neurological or rheumatological pathology hindering the use of the upper limbs
• Inability to understand
• Minors
• Major persons subject to legal protection (legal safeguards, guardianship)
• Persons deprived of their liberty

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with multiple sclerosis	Validation of AMSQ questionnaire	Patients with MS according to the diagnostic criteria of 2010 Validation of AMSQ questionnaire

Primary Outcome Measures

Name	Time	Method
Validate the French version of the AMSQ self-questionnaire in a population of MS patients	At inclusion	Evaluate item fit of the French version of the AMSQ using the graded response model, developed by Samejima (cf. reference)

Trial Locations

Locations (1)

Rennes University Hospital; 🇫🇷 Rennes, France