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

Assistance Publique - Hôpitaux de Paris240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

240

Conditions

Multiple Sclerosis

Interventions

Combined programBEHAVIORAL

Combined program with physiotherapy, endurance training and resistance training

Physiotherapy in private practiceBEHAVIORAL

Physiotherapy in private practice

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE

Garches, Hauts DE Seine, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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