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

NCT ID: NCT03655093

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-25

Study Completion Date

2017-07-03

Brief Summary

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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

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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

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Multiple Sclerosis

Keywords

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Multiple sclerosis Self-questionnaire Measurement tools

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with multiple sclerosis

Patients with MS according to the diagnostic criteria of 2010 Validation of AMSQ questionnaire

Validation of AMSQ questionnaire

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Kerbrat, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

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Rennes University Hospital

Rennes, , France

Site Status

Countries

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France

References

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

Reference Type BACKGROUND

Other Identifiers

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2017-A00788-45

Identifier Type: OTHER

Identifier Source: secondary_id

35RC17_3063

Identifier Type: -

Identifier Source: org_study_id