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

NCT03655093 | Completed

• 2 other identifiers: 35RC17_30632017-A00788-45
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Self-questionnaire; Measurement tools

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with multiple sclerosis

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

Other: Validation of AMSQ questionnaire

Interventions

Validation of AMSQ questionnaire 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.

Patients with multiple sclerosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with MS according to the diagnostic criteria of 2010

You may qualify if:

• Patient with MS according to the diagnostic criteria of 2010
• Age ≥18 years
• Patients seen in consultation at the SEP reference center in Rennes

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, 35000, France

Location

Related Publications (1)

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

  BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Anne Kerbrat, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: August 31, 2018
• Study Start: April 25, 2017
• Primary Completion: July 3, 2017
• Study Completion: July 3, 2017
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

FR (1)