NCT03655093

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-04-25
• Primary completion: 2017-07-03
• Completion: 2017-07-03
• First posted: 2018-08-31
• Last updated: 2018-08-31

Locations

1 site across 1 country: France