Physical Capacity and Rehabilitation of Patients With Multiple Sclerosis
NCT ID: NCT02352194
Last Updated: 2015-02-02
Study Results
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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UNKNOWN
60 participants
OBSERVATIONAL
2014-07-31
2015-10-31
Brief Summary
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Detailed Description
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In order to assess the efficiency of the of usual rehabilitation proposed to patients in the day hospital, assessments are systematically performed before and after the rehabilitation program:
1. Assessment of muscular strength and fatigue:
Assessments of voluntary force will be those usually performed in the context of the evaluation of patients. The isokinetic dynamometer CON-TREX ® is a device that provides a quantified result of the torque developed in a predetermined joint area with a constant speed which is also defined in advance.
The assessment includes an assessment of the strength in isometric contraction (at 40 and 90 degrees of knee flexion) and concentric contraction (30, 60 and 90 degrees per second). Fatigue is evaluated by two self-administered questionnaires: the Fatigue Severity Scale and Modified Fatigue Impact Scale.
2. Effort test:
The aerobic capacity of patients will be assessed by a triangular maximal exercise test.
The effort test is performed on a cycle ergometer from a triangular incremental exercise. Beforehand, blood pressure and ECG are recorded to establish that the patient can safely achieve a gradual stress test. Heart rate, blood pressure, oxygen consumption, the feeling (Borg scale) and ECG are recorded immediately before and immediately after the end of the test and every minute for at least 5-10 minutes during the recovery phase.
3. Clinical assessment:
The Timed Up and Go test will be used to assess the patient's capacity of postural transition.
This is a timed quantitative assessment of the duration needed to change from sitting in a chair, get up and walk three meters, make a U-turn and come back to sit down.
The 10 meters test quantifies the walking speed of patients (meters / second) over 10 meters A test of ascending and descending10 stairs is also performed, as well as the 6 minutes walking test.
In addition to these functional assessments, clinical tests are conventionally performed such as the measurement of muscle strength (Medical Research Council scale), range of motion, spasticity (modified Ashworth scale) and an assessment of the balance and posture.
The SEP-59 questionnaire will be used to assess the patients quality of life.
Conditions
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Study Design
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COHORT
Study Groups
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Assessment
One part of this study is to quantify physical capacity of patients with Multiple sclerosis.
Thirty patients will be enrolled in this study and performed assessments.
No interventions assigned to this group
Rehabilitation
A second part of this study is to quantify the benefit of a usual rehabilitation program in the day hospital. Thirty patients will be enrolled in this study and receive rehabilitation. They will be assessed before and after the rehabilitation program (physiotherapy and physical activity)
Rehabilitation
Physiotherapy and physical activity
Interventions
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Rehabilitation
Physiotherapy and physical activity
Eligibility Criteria
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Inclusion Criteria
* 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
* Breastfeeding
* Orthopedic complications with repercussions on walking activities
* No affiliation to a social security scheme (beneficiary or assignee)
18 Years
80 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Djamel Bensmail, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Physical and Rehabilitation Medicine department, Raymond Poincaré Hospital,
Raphael Zory, PhD
Role: STUDY_DIRECTOR
LAMHESS Laboratory, Faculty of Sports Science, 06205 Nice, France
Sophie Hameau
Role: STUDY_DIRECTOR
Physical and Rehabilitation Medicine department, Raymond Poincaré Hospital,
Locations
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Raymond Poincaré Hospital
Garches, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Hameau S, Bensmail D, Roche N, Zory R. Fatigability in Patients With Multiple Sclerosis During Maximal Concentric Contractions. Arch Phys Med Rehabil. 2017 Jul;98(7):1339-1347. doi: 10.1016/j.apmr.2016.12.014. Epub 2017 Jan 25.
Other Identifiers
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14-REHABSEP
Identifier Type: -
Identifier Source: org_study_id
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