A Trial to Compare the Effectiveness of Two Rehabilitation Programs for Multiple Sclerosis Patients
- Conditions
- Multiple Sclerosis
- Interventions
- Behavioral: Physiotherapy in private practiceBehavioral: Combined program
- Registration Number
- NCT01871818
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physiotherapy Physiotherapy in private practice Active comparator: physiotherapy in private practice 120 patients will receive this usual rehabilitation Combined program Combined program Combined program with physiotherapy, endurance training and resistance training. 120 patients will receive this combined program
- Primary Outcome Measures
Name Time Method 6 Minute Walk Test 6 Minutes 6 Minute Walk Test (6MWT) at the end of the rehabilitation program (Time Frame : at one month M1)
- Secondary Outcome Measures
Name Time Method Aerobic capacity 1h Aerobic capacity (V02 max)
Strength and fatigue of the knee flexors and extensors 45 min Assessment of maximal voluntary strength using an isokinetic dynamometer or assessment of maximal voluntary strength using the 1-RM estimation
Quality of Life assessment 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 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 = 6minClinical assessment 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 15 min
Trial Locations
- Locations (1)
Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE
🇫🇷Garches, Hauts DE Seine, France