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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01871818
First received: May 24, 2013
Last updated: January 20, 2014
Last verified: November 2012
  Purpose

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.


Condition Intervention
Primary Progressive Multiple Sclerosis,
Secondary Progressive Multiple Sclerosis
Relapsing-remitting Multiple Sclerosis,
Demyelinating Autoimmune Diseases,
Nervous System Diseases
Behavioral: Combined program
Behavioral: Physiotherapy in private practice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-centre Randomised Controlled Trial to Compare the Effectiveness of Two Rehabilitation Programs in Patients With Multiple Sclerosis.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 6 Minute Walk Test [ Time Frame: 6 Minutes ] [ Designated as safety issue: Yes ]
    6 Minute Walk Test (6MWT) at the end of the rehabilitation program (Time Frame : at one month M1)


Secondary Outcome Measures:
  • Functional tests [ Time Frame: 20 Minutes ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    Aerobic capacity (V02 max)

  • Strength and fatigue of the knee flexors and extensors [ Time Frame: 45 min ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Quality of Life assessment [ Time Frame: 55 min ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 240
Study Start Date: May 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combined program

Combined program with physiotherapy, endurance training and resistance training.

120 patients will receive this combined program

Behavioral: Combined program
Combined program with physiotherapy, endurance training and resistance training
Active Comparator: Physiotherapy
Active comparator: physiotherapy in private practice 120 patients will receive this usual rehabilitation
Behavioral: Physiotherapy in private practice
Physiotherapy in private practice

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01871818

Contacts
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

Locations
France
Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE Recruiting
Garches, Hauts de Seine, France, 92380
Contact: DJAMEL BENSMAIL, MD    +33 (0)1 47 10 70 60    djamel.bensmail@rpc.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Djamel Bensmail, MD Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01871818     History of Changes
Other Study ID Numbers: P110116
Study First Received: May 24, 2013
Last Updated: January 20, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Multiple sclerosis
Rehabilitation
Chronic evolutive disease
Physiotherapy
Resistance training
Endurance training

Additional relevant MeSH terms:
Autoimmune Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Nervous System Diseases
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 01, 2014