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

Multiple Sclerosis Clinical Trial

— MS-SEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03655093
• Other study ID #: 35RC17_3063
• Secondary ID: 2017-A00788-45
• Status: Completed
• Start date: April 25, 2017
• Est. completion date: July 3, 2017

Study information

• Verified date: August 2018
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 3, 2017
• Est. primary completion date: July 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validate the French version of the AMSQ self-questionnaire in a population of MS patients	Evaluate item fit of the French version of the AMSQ using the graded response model, developed by Samejima (cf. reference)	At inclusion