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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Combined program
Physiotherapy in private practice
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Rehabilitation, Chronic evolutive disease, Physiotherapy, Resistance training, Endurance training

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined program

Physiotherapy

Arm Description

Combined program with physiotherapy, endurance training and resistance training. 120 patients will receive this combined program

Active comparator: physiotherapy in private practice 120 patients will receive this usual rehabilitation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Aerobic capacity
Aerobic capacity (V02 max)
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
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.
Balance (Berg Balance scale) and postural control assessment
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)

Full Information

First Posted
May 24, 2013
Last Updated
October 22, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01871818
Brief Title
A Trial to Compare the Effectiveness of Two Rehabilitation Programs for Multiple Sclerosis Patients
Acronym
REHABMUSCLE
Official Title
A Multi-centre Randomised Controlled Trial to Compare the Effectiveness of Two Rehabilitation Programs in Patients With Multiple Sclerosis.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, Rehabilitation, Chronic evolutive disease, Physiotherapy, Resistance training, Endurance training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined program
Arm Type
Experimental
Arm Description
Combined program with physiotherapy, endurance training and resistance training. 120 patients will receive this combined program
Arm Title
Physiotherapy
Arm Type
Active Comparator
Arm Description
Active comparator: physiotherapy in private practice 120 patients will receive this usual rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Combined program
Intervention Description
Combined program with physiotherapy, endurance training and resistance training
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapy in private practice
Intervention Description
Physiotherapy in private practice
Primary Outcome Measure Information:
Title
6 Minute Walk Test
Description
6 Minute Walk Test (6MWT) at the end of the rehabilitation program (Time Frame : at one month M1)
Time Frame
6 Minutes
Secondary Outcome Measure Information:
Title
Functional tests
Description
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
Time Frame
20 Minutes
Title
Aerobic capacity
Description
Aerobic capacity (V02 max)
Time Frame
1h
Title
Strength and fatigue of the knee flexors and extensors
Description
Assessment of maximal voluntary strength using an isokinetic dynamometer or assessment of maximal voluntary strength using the 1-RM estimation
Time Frame
45 min
Title
Clinical assessment
Description
Spasticity assessment (Modified Ashworth Scale), passive range of motion of lower limb joint, lower limb strength (Medical Research Council scale), self questionnaire of pain.
Time Frame
45 min
Title
Balance (Berg Balance scale) and postural control assessment
Time Frame
15 min
Title
Quality of Life assessment
Description
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)
Time Frame
55 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Djamel Bensmail, MD
Organizational Affiliation
Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE
City
Garches
State/Province
Hauts DE Seine
ZIP/Postal Code
92380
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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