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Completed

NCT Number: NCT01871818

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

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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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE

Garches, Hauts DE Seine, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined program

Behavioral

Combined program with physiotherapy, endurance training and resistance training

Physiotherapy in private practice

Behavioral

Physiotherapy in private practice

Primary outcomes

  1. 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)

Secondary outcomes

  1. Functional tests

    Time frame: 20 Minutes

    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

  2. Aerobic capacity

    Time frame: 1h

    Aerobic capacity (V02 max)

  3. Strength and fatigue of the knee flexors and extensors

    Time frame: 45 min

    Assessment of maximal voluntary strength using an isokinetic dynamometer or assessment of maximal voluntary strength using the 1-RM estimation

  4. Clinical assessment

    Time frame: 45 min

    Spasticity assessment (Modified Ashworth Scale), passive range of motion of lower limb joint, lower limb strength (Medical Research Council scale), self questionnaire of pain.

  5. Balance (Berg Balance scale) and postural control assessment

    Time frame: 15 min

  6. Quality of Life assessment

    Time frame: 55 min

    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)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

A Multi-centre Randomised Controlled Trial to Compare the Effectiveness of Two Rehabilitation Programs in Patients With Multiple Sclerosis.

Acronym: REHABMUSCLE

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jun 7, 2013
Registry last updated
Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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