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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Combined program; Behavioral: Physiotherapy in private practice

Study type: Interventional

Funder types: Other

Identifiers

NCT01871818

P110116

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 2 patient groups

Combined program

Experimental group

Description:

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

Treatment:

Behavioral: Combined program

Physiotherapy

Active Comparator group

Description:

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

Treatment:

Behavioral: Physiotherapy in private practice