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

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

Sponsors

Lead sponsor: Rennes University Hospital

Source 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.

Overall Status Completed
Start Date April 25, 2017
Completion Date July 3, 2017
Primary Completion Date July 3, 2017
Study Type Observational
Primary Outcome
Measure Time Frame
Validate the French version of the AMSQ self-questionnaire in a population of MS patients At inclusion
Enrollment 200
Condition
Intervention

Intervention type: Other

Intervention name: Validation of AMSQ questionnaire

Description: 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.

Arm group label: Patients with multiple sclerosis

Eligibility

Sampling method: Non-Probability Sample

Criteria:

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: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Anne Kerbrat, MD Principal Investigator Rennes University Hospital
Location
facility
Rennes University Hospital
Location Countries

France

Verification Date

August 2018

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Patients with multiple sclerosis

Description: Patients with MS according to the diagnostic criteria of 2010 Validation of AMSQ questionnaire

Acronym MS-SEP
Patient Data Undecided
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov