Multiple SclerosisREHABMUSCLENCT01871818
A Trial to Compare the Effectiveness of Two Rehabilitation Programs for Multiple Sclerosis Patients
A study testing Combined program and Physiotherapy in private practice in people with Multiple Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Combined program and Physiotherapy in private practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE
Garches, Hauts DE Seine, 92380
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Combined program, Physiotherapy in private practice
- Keywords
- Multiple sclerosis, Rehabilitation, Chronic evolutive disease, Physiotherapy, Resistance training, Endurance training
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined programBehavioural
Combined program with physiotherapy, endurance training and resistance training
Physiotherapy in private practiceBehavioural
Physiotherapy in private practice
| Study group | Role | What they receive |
|---|---|---|
| Combined program | Experimental | Combined program with physiotherapy, endurance training and resistance training.
120 patients will receive this combined program Receives: Behavioral: Combined program |
| Physiotherapy | Active comparator | Active comparator: physiotherapy in private practice 120 patients will receive this usual rehabilitation Receives: Behavioral: Physiotherapy in private practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Test
6 Minute Walk Test (6MWT) at the end of the rehabilitation program (Time Frame : at one month M1)
Measured: 6 Minutes
Secondary outcomes (6)
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
Measured: 20 Minutes
Aerobic capacity
Aerobic capacity (V02 max)
Measured: 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
Measured: 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.
Measured: 45 min
Balance (Berg Balance scale) and postural control assessment
Measured: 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)
Measured: 55 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionApr 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Djamel Bensmail, MD, Principal investigator, Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871818
- Sponsor's protocol ID
- P110116
- Acronym
- REHABMUSCLE
- Status last verified
- Nov 2017
- First submitted
- 24 May 2013
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bonnyaud C, Hameau S, Zory R, Sznajder M, Heinzlef O, Aymard C, Chenet A, Medee B, Jacota M, Gallien P, Bensmail D; Rehabmuscle Team. Intensive interdisciplinary specialized rehabilitation or regular physiotherapy for multiple sclerosis? A randomised controlled trial with economic evaluation. Ann Phys Rehabil Med. 2025 Mar;68(2):101898. doi: 10.1016/j.rehab.2024.101898. Epub 2025 Jan 15.
PubMed 39818009
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Randomised Controlled Trial to Compare the Effectiveness of Two Rehabilitation Programs in Patients With Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT01871818
- Acronym / sponsor ID
- REHABMUSCLE / P110116
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Rehabilitation, Chronic evolutive disease, Physiotherapy, Resistance training, Endurance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined program | Experimental | Behavioral: Combined programCombined program with physiotherapy, endurance training and resistance training. 120 patients will receive this combined program |
| Physiotherapy | Active comparator | Behavioral: Physiotherapy in private practiceActive comparator: physiotherapy in private practice 120 patients will receive this usual rehabilitation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined programCombined program with physiotherapy, endurance training and resistance training | Behavioural | Combined program |
| Physiotherapy in private practicePhysiotherapy in private practice | Behavioural | Physiotherapy |
Primary outcome
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)
6 secondary outcomes
Functional tests
Time frame: 20 Minutes
Aerobic capacity
Time frame: 1h
Strength and fatigue of the knee flexors and extensors
Time frame: 45 min
Clinical assessment
Time frame: 45 min
Balance (Berg Balance scale) and postural control assessment
Time frame: 15 min
Quality of Life assessment
Time frame: 55 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Derived from this study: PubMed 39818009Bonnyaud C, Hameau S, Zory R, Sznajder M, Heinzlef O, Aymard C, Chenet A, Medee B, Jacota M, Gallien P, Bensmail D; Rehabmuscle Team. Intensive interdisciplinary specialized rehabilitation or regular physiotherapy for multiple sclerosis? A randomised controlled trial with economic evaluation. Ann Phys Rehabil Med. 2025 Mar;68(2):101898. doi: 10.1016/j.rehab.2024.101898. Epub 2025 Jan 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Djamel Bensmail, MD principal investigator
Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined program and Physiotherapy in private practice in people with Multiple Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walk Test (time frame: 6 Minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01871818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.