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A Trial to Compare the Effectiveness of Two Rehabilitation Programs for Multiple Sclerosis Patients (REHABMUSCLE)

This study is currently recruiting participants.
Verified November 2016 by Assistance Publique - Hôpitaux de Paris
Sponsor:
ClinicalTrials.gov Identifier:
NCT01871818
First Posted: June 7, 2013
Last Update Posted: November 4, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
May 24, 2013
June 7, 2013
November 4, 2016
May 2013
November 2017   (Final data collection date for primary outcome measure)
6 Minute Walk Test [ Time Frame: 6 Minutes ]
6 Minute Walk Test (6MWT) at the end of the rehabilitation program (Time Frame : at one month M1)
Same as current
Complete list of historical versions of study NCT01871818 on ClinicalTrials.gov Archive Site
  • Functional tests [ Time Frame: 20 Minutes ]

    Functional tests: 10 meters Walk Test, Timed up and go test, Time to ascend and descend stairs, 6 Minute Walk Test

    Time frame:10 meters walk test = 2 min ; time up and going test= 4 min ; Time to ascend and descend stairs = 4 min ; et 6min walk = 6min

  • Aerobic capacity [ Time Frame: 1h ]
    Aerobic capacity (V02 max)
  • Strength and fatigue of the knee flexors and extensors [ Time Frame: 45 min ]
    Assessment of maximal voluntary strength using an isokinetic dynamometer or assessment of maximal voluntary strength using the 1-RM estimation
  • Clinical assessment [ Time Frame: 45 min ]
    Spasticity assessment (Modified Ashworth Scale), passive range of motion of lower limb joint, lower limb strength (Medical Research Council scale), self questionnaire of pain.
  • Balance (Berg Balance scale) and postural control assessment [ Time Frame: 15 min ]
  • Quality of Life assessment [ Time Frame: 55 min ]
    Quality of Life assessed by self-reported questionnaire (SEP -59; EQ-5D), mood (HAD), MSIS-29, auto-questionnaire estimating the fatigue (Fatigue Severity Scale, Modified Fatigue Impact Scale)
  • Functional tests [ Time Frame: 20 Minutes ]

    Functional tests: 10 meters Walk Test, Timed up and go test, Time to ascend and descend stairs, 6 Minute Walk Test

    Time frame:10 meters walk test = 2 min ; time up and going test= 4 min ; Time to ascend and descend stairs = 4 min ; et 6min walk = 6min

  • Aerobic capacity [ Time Frame: 1h ]
    Aerobic capacity (V02 max)
  • Strength and fatigue of the knee flexors and extensors [ Time Frame: 45 min ]
    Assessment of maximal voluntary strength using an isokinetic dynamometer or assessment of maximal voluntary strength using the 1-RM estimation
  • Clinical assessment [ Time Frame: 45 min ]
    Spasticity assessment (Modified Ashworth Scale), passive range of motion of lower limb joint, lower limb strength (Medical Research Council scale), self questionnaire of pain.
  • Balance (Berg Balance scale) and postural control assessment [ Time Frame: 15 min ]
  • Quality of Life assessement [ Time Frame: 55 min ]
    Quality of Life assessed by self-reported questionnaire (SEP -59; EQ-5D), mood (HAD), MSIS-29, auto-questionnaire estimating the fatigue (Fatigue Severity Scale, Modified Fatigue Impact Scale)
Not Provided
Not Provided
 
A Trial to Compare the Effectiveness of Two Rehabilitation Programs for Multiple Sclerosis Patients
A Multi-centre Randomised Controlled Trial to Compare the Effectiveness of Two Rehabilitation Programs in Patients With Multiple Sclerosis.
The purpose of this study was to compare the effectiveness of two rehabilitation programs (one month) in patients with multiple sclerosis. The first program is combined with physiotherapy, endurance training and resistance training. The second one is physiotherapy in private practice. Another purpose is to assess the length of the benefits of the combined program.
This study will include 240 patients with a diagnosis of Multiple Sclerosis and with an Expanded Disability Status Scale ≤ 5. Patients will be divided into 2 groups, according to a randomization design. At recruitment (J0), after rehabilitation (M1) and at follow up (M3 and M6) each patient will be tested for the primary and secondary outcomes.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis
  • Behavioral: Combined program
    Combined program with physiotherapy, endurance training and resistance training
  • Behavioral: Physiotherapy in private practice
    Physiotherapy in private practice
  • Experimental: Combined program

    Combined program with physiotherapy, endurance training and resistance training.

    120 patients will receive this combined program

    Intervention: Behavioral: Combined program
  • Active Comparator: Physiotherapy
    Active comparator: physiotherapy in private practice 120 patients will receive this usual rehabilitation
    Intervention: Behavioral: Physiotherapy in private practice
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
May 2018
November 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 year or over
  • Able to walk independently without use of assistance 200 meters Expanded Disability Status Scale ≤5
  • No relapse within the last three months
  • No current or recent (six months) participation in intensive rehabilitation
  • No recent modification (six months) of medications for MS
  • Patients who received and signed information and informed consent

Exclusion Criteria:

  • Cognitive impairments which could interfere with the ability to fully engage the rehabilitation program.
  • Recent involvement (three months) in another interventional research study
  • A complicating medical condition or orthopedic diagnosis that limits rehabilitation
  • Cardiac or respiratory disease that interfere with endurance training
  • Patient with safety measure
  • Pregnant women, breastfeeding
  • No affiliation to a social security
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact: Djamel Bensmail, MD +33 (0) 1 47 10 70 60 djamel.bensmail@rpc.aphp.fr
Contact: Sophie Hameau +33 (0) 1 47 10 79 00 ext 50 25 sophie.hameau@rpc.aphp.fr
France
 
 
NCT01871818
P110116
Yes
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Djamel Bensmail, MD Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France
Assistance Publique - Hôpitaux de Paris
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP