NCT01871818

Brief 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. Another purpose is to assess the length of the benefits of the combined program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 23, 2018

Status Verified

November 1, 2017

Enrollment Period

3.9 years

First QC Date

May 24, 2013

Last Update Submit

October 22, 2018

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosisRehabilitationChronic evolutive diseasePhysiotherapyResistance trainingEndurance training

Outcome Measures

Primary Outcomes (1)

  • 6 Minute Walk Test

    6 Minute Walk Test (6MWT) at the end of the rehabilitation program (Time Frame : at one month M1)

    6 Minutes

Secondary Outcomes (6)

  • Functional tests

    20 Minutes

  • Aerobic capacity

    1h

  • Strength and fatigue of the knee flexors and extensors

    45 min

  • Clinical assessment

    45 min

  • Balance (Berg Balance scale) and postural control assessment

    15 min

  • +1 more secondary outcomes

Study Arms (2)

Combined program

EXPERIMENTAL

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

Behavioral: Combined program

Physiotherapy

ACTIVE COMPARATOR

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

Behavioral: Physiotherapy in private practice

Interventions

Combined programBEHAVIORAL

Combined program with physiotherapy, endurance training and resistance training

Combined program
Physiotherapy in private practiceBEHAVIORAL

Physiotherapy in private practice

Physiotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE

Garches, Hauts DE Seine, 92380, France

Location

Related Publications (1)

  • 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.

    PMID: 39818009DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Physical Therapy ModalitiesPrivate Practice

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationProfessional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Djamel Bensmail, MD

    Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2013

First Posted

June 7, 2013

Study Start

May 1, 2013

Primary Completion

April 1, 2017

Study Completion

October 1, 2017

Last Updated

October 23, 2018

Record last verified: 2017-11

Locations

FR(1)