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Physical Capacity and Rehabilitation of Patients With Multiple Sclerosis (REHABSEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02352194
Recruitment Status : Unknown
Verified May 2014 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : February 2, 2015
Last Update Posted : February 2, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The purpose of this study is to assess the physical capacity of patients with multiple sclerosis and the effects of rehabilitation, encompassing physical therapy and physical activity as it is carried out in the day hospital of (the Physical and Rehabilitation Medicine department) at Garches Hospital. We will compare the results of assessments carried out before and after a standard rehabilitation program.

Condition or disease Intervention/treatment
Multiple Sclerosis (MS) Other: Rehabilitation

Detailed Description:

Single center, retrospective and prospective study.

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Official Title: Observational Study of the Physical Capacity of Patients With Multiple Sclerosis and Evaluation of the Effects of Usual Rehabilitation in the Day Hospital
Study Start Date : July 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

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)
Other: Rehabilitation
Physiotherapy and physical activity




Primary Outcome Measures :
  1. Assessment of the strength and fatigue [ Time Frame: Within 10 weeks from the start of the rehabilitation program ]
    Assessment realised with an isokinetic dynamometer


Secondary Outcome Measures :
  1. 6 minutes walking test [ Time Frame: Within 10 weeks from the start of the rehabilitation program ]
    Patients were instructed to walk as far as possible in a 50 meters corridor during 6 minutes

  2. Evaluation of aerobic capacity during an effort test [ Time Frame: Within 10 weeks from the start of the rehabilitation program ]
    Aerobic capacity (VO2max)

  3. Assessment of the balance of patients [ Time Frame: Within 10 weeks from the start of the rehabilitation program ]
    Berg Balance Scale

  4. Assessment of Spasticity with the Modified Ashworth Scale (MAS), [ Time Frame: Within 10 weeks from the start of the rehabilitation program ]
  5. 10 meters Walk test [ Time Frame: Within 10 weeks from the start of the rehabilitation ]
    Patients have to walk over a 14 meter walkway and time required to traverse the middle 10 meters of the walk was recorded to avoid acceleration and deceleration effects

  6. Timed up and go test [ Time Frame: Within 10 weeks from the start of the rehabilitation ]
    Patients have to get up from a chair, walk 3 meters, turn around and return to sitting as quickly as possible

  7. Time to ascend and descend stairs [ Time Frame: Within 10 weeks from the start of the rehabilitation ]
    Participants were instructed to ascend and descend 10 stairs using the hand rail

  8. Assessment of Strength with the Medical Research Council (MRC), [ Time Frame: Within 10 weeks from the start of the rehabilitation ]
  9. Assessment of Quality of Life with SEP-59 Scale [ Time Frame: Within 10 weeks from the start of the rehabilitation ]
  10. Assessment of the balance of patients [ Time Frame: Within 10 weeks from the start of the rehabilitation ]
    Postural control assessment : eyes opened and eyes closed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients diagnosed with MS since at least 3 months
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352194


Contacts
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Contact: Djamel Bensmail, MD, PhD +33147107060 djamel.bensmail@rpc.aphp.fr

Locations
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France
Raymond Poincaré Hospital Recruiting
Garches, France, 92380
Contact: Djamel Bensmail, MD,PhD    +33147107060    djamel.bensmail@rpc.aphp.fr   
Contact: Hameau Sophie    +33171144921    sophie.hameau@rpc.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Djamel Bensmail, MD,PhD Physical and Rehabilitation Medicine department, Raymond Poincaré Hospital,
Study Director: Raphael Zory, PhD LAMHESS Laboratory, Faculty of Sports Science, 06205 Nice, France
Study Director: Sophie Hameau Physical and Rehabilitation Medicine department, Raymond Poincaré Hospital,
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02352194    
Other Study ID Numbers: 14-REHABSEP
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: May 2014
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Multiple Sclerosis, Physical therapy, Physical capacity, Fatigue
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases