Validation of a Self-questionnaire in French on the Use of the Upper Limbs in Patients With Multiple Sclerosis (MS-SEP)
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|ClinicalTrials.gov Identifier: NCT03655093|
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis||Other: Validation of AMSQ questionnaire|
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|
|Actual Enrollment :||200 participants|
|Official Title:||Validation of a Self-questionnaire in French on the Use of the Upper Limbs in Patients With Multiple Sclerosis|
|Actual Study Start Date :||April 25, 2017|
|Actual Primary Completion Date :||July 3, 2017|
|Actual Study Completion Date :||July 3, 2017|
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.
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03655093
|Rennes University Hospital|
|Rennes, France, 35000|
|Principal Investigator:||Anne Kerbrat, MD||Rennes University Hospital|