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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03655093
Acronym
MS-SEP
Enrollment
200
Registered
2018-08-31
Start date
2017-04-25
Completion date
2017-07-03
Last updated
2018-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis, Self-questionnaire, Measurement tools

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.

Interventions

OTHERValidation 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.

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Validate the French version of the AMSQ self-questionnaire in a population of MS patientsAt inclusionEvaluate item fit of the French version of the AMSQ using the graded response model, developed by Samejima (cf. reference)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026