An interventional study of Combined program and Physiotherapy in private practice in Multiple Sclerosis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-10-23.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
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.
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's planned enrollment of 240 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Combined program with physiotherapy, endurance training and resistance training. 120 patients will receive this combined program
Behavioral: Combined program
Active comparator: physiotherapy in private practice 120 patients will receive this usual rehabilitation
Behavioral: Physiotherapy in private practice
Combined program with physiotherapy, endurance training and resistance training
Physiotherapy in private practice
6 Minute Walk Test
6 Minute Walk Test (6MWT) at the end of the rehabilitation program (Time Frame : at one month M1)
Time frame: 6 Minutes
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
Time frame: 20 Minutes
Aerobic capacity
Aerobic capacity (V02 max)
Time frame: 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
Time frame: 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.
Time frame: 45 min
Balance (Berg Balance scale) and postural control assessment
Time frame: 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)
Time frame: 55 min
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assistance Publique - Hôpitaux de Paris