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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Combined program; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Hauts DE Seine
    • Garches, Hauts DE Seine, France, 92380
      • Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 Minute Walk Test	6 Minute Walk Test (6MWT) at the end of the rehabilitation program (Time Frame : at one month M1)	6 Minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional tests	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	20 Minutes
Aerobic capacity	Aerobic capacity (V02 max)	1h
Strength and fatigue of the knee flexors and extensors	Assessment of maximal voluntary strength using an isokinetic dynamometer or assessment of maximal voluntary strength using the 1-RM estimation	45 min
Clinical assessment	Spasticity assessment (Modified Ashworth Scale), passive range of motion of lower limb joint, lower limb strength (Medical Research Council scale), self questionnaire of pain.	45 min
Balance (Berg Balance scale) and postural control assessment		15 min
Quality of Life assessment	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)	55 min

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Djamel Bensmail, MD, Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: May 24, 2013
• First Submitted That Met QC Criteria: June 4, 2013
• First Posted (Estimate): June 7, 2013

Study Record Updates

• Last Update Posted (Actual): October 23, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Rehabilitation; Multiple sclerosis; Physiotherapy; Endurance training; Resistance training; Chronic evolutive disease
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: P110116