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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 3, 2017

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.

Interventions

  • Other: Validation of AMSQ questionnaire
    • Participation in the study will be proposed to any patient meeting the inclusion criteria and consulting a neurologist from the SEP reference center of the University Hospital of Rennes. The neurologist will explain the purpose of the study to the patient, give him the information form. Without opposition from the patient, the neurologist will give him the self-questionnaire. The patient will fill it during the consultation. In case of disability to the upper limbs making it impossible to fill the questionnaire by the patient, it will be filled by the neurologist or the patient’s companion, according to the answers given by the patient. While the patient completes the questionnaire, a record of clinical information will be filled in by the neurologist. No additional act will be performed except the questionnaire, which result will not change the patient’s management.

Arms, Groups and Cohorts

  • Patients with multiple sclerosis
    • Patients with MS according to the diagnostic criteria of 2010 Validation of AMSQ questionnaire

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rennes University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anne Kerbrat, MD, Principal Investigator, Rennes University Hospital

References

Samejima F. Estimation of latent ability using a response pattern of graded scores. Richmond, VA: The Psychometric Society, 1969.

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