A Multi-centre Randomised Controlled Trial to Compare the Effectiveness of Two Rehabilitation Programs in Patients With Multiple Sclerosis.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- 6 Minute Walk Test
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Aerobic capacity(1h)
- Strength and fatigue of the knee flexors and extensors(45 min)
- Quality of Life assessment(55 min)
- Functional tests(20 Minutes)
- Clinical assessment(45 min)
- Balance (Berg Balance scale) and postural control assessment(15 min)