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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rennes University Hospital

Rennes, 35000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Validation of AMSQ questionnaire

Other

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.

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: MS-SEP

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Aug 31, 2018
Registry last updated: Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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