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

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 Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Validation of AMSQ questionnaire

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • Rennes University Hospital

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: Non-Probability Sample

Study Population

Patients with MS according to the diagnostic criteria of 2010

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Anne Kerbrat, MD, Rennes University Hospital

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2017
• Primary Completion (Actual): July 3, 2017
• Study Completion (Actual): July 3, 2017

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Multiple sclerosis; Self-questionnaire; Measurement tools
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 35RC17_3063; 2017-A00788-45 (Other Identifier: ID RCB)

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