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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
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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.

Condition or disease Intervention/treatment
Multiple Sclerosis 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.


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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with MS according to the diagnostic criteria of 2010
Criteria

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

Information from the National Library of Medicine

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


Locations
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France
Rennes University Hospital
Rennes, France, 35000
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Anne Kerbrat, MD Rennes University Hospital

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

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03655093     History of Changes
Other Study ID Numbers: 35RC17_3063
2017-A00788-45 ( Other Identifier: ID RCB )
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
Multiple sclerosis
Self-questionnaire
Measurement tools
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases