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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02352194 |
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Date of registration:
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20/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Physical Capacity and Rehabilitation of Patients With Multiple Sclerosis
REHABSEP |
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Scientific title:
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Observational Study of the Physical Capacity of Patients With Multiple Sclerosis and Evaluation of the Effects of Usual Rehabilitation in the Day Hospital |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02352194 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Djamel Bensmail, MD, PhD |
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Address:
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Telephone:
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+33147107060 |
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Email:
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djamel.bensmail@rpc.aphp.fr |
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Affiliation:
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Name:
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Djamel Bensmail, MD,PhD |
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Address:
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Telephone:
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+33147107060 |
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Email:
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djamel.bensmail@rpc.aphp.fr |
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Affiliation:
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Name:
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Raphael Zory, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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LAMHESS Laboratory, Faculty of Sports Science, 06205 Nice, France |
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Name:
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Djamel Bensmail, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Physical and Rehabilitation Medicine department, Raymond Poincaré Hospital, |
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Name:
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Sophie Hameau |
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Address:
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Telephone:
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Email:
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Affiliation:
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Physical and Rehabilitation Medicine department, Raymond Poincaré Hospital, |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Multiple Sclerosis with EDSS = 6 (Expanded Disability Status Scale)
- Patient = 18 years old
- Patient able to comply with the recommended monitoring
- No relapse within the last three months
- More than six months elapsed since last medical care in day hospital
- No recent modification (six month) of medications for MS
- More than three months elapsed since last change of associated treatments (Fampyra,
botulinum toxin)
Exclusion Criteria:
- Patients under any form of guardianship or curatorship
- Breastfeeding
- Orthopedic complications with repercussions on walking activities
- No affiliation to a social security scheme (beneficiary or assignee)
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis (MS)
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Intervention(s)
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Other: Rehabilitation
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Primary Outcome(s)
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Assessment of the strength and fatigue
[Time Frame: Within 10 weeks from the start of the rehabilitation program]
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Secondary Outcome(s)
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Assessment of Quality of Life with SEP-59 Scale
[Time Frame: Within 10 weeks from the start of the rehabilitation]
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6 minutes walking test
[Time Frame: Within 10 weeks from the start of the rehabilitation program]
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Assessment of Spasticity with the Modified Ashworth Scale (MAS),
[Time Frame: Within 10 weeks from the start of the rehabilitation program]
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Assessment of the balance of patients
[Time Frame: Within 10 weeks from the start of the rehabilitation program]
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10 meters Walk test
[Time Frame: Within 10 weeks from the start of the rehabilitation]
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Assessment of the balance of patients
[Time Frame: Within 10 weeks from the start of the rehabilitation]
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Time to ascend and descend stairs
[Time Frame: Within 10 weeks from the start of the rehabilitation]
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Assessment of Strength with the Medical Research Council (MRC),
[Time Frame: Within 10 weeks from the start of the rehabilitation]
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Evaluation of aerobic capacity during an effort test
[Time Frame: Within 10 weeks from the start of the rehabilitation program]
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Timed up and go test
[Time Frame: Within 10 weeks from the start of the rehabilitation]
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Secondary ID(s)
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14-REHABSEP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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