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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2017-10-31

Brief Summary

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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.

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Detailed Description

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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

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Combined program

Combined program with physiotherapy, endurance training and resistance training.

120 patients will receive this combined program

Group Type EXPERIMENTAL

Combined program

Intervention Type BEHAVIORAL

Combined program with physiotherapy, endurance training and resistance training

Physiotherapy

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

Group Type ACTIVE_COMPARATOR

Physiotherapy in private practice

Intervention Type BEHAVIORAL

Physiotherapy in private practice

Interventions

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Combined program

Combined program with physiotherapy, endurance training and resistance training

Intervention Type BEHAVIORAL

Physiotherapy in private practice

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No