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

Multiple Sclerosis Clinical Trial

— REHABMUSCLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01871818
• Other study ID #: P110116
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: October 2017

Study information

• Verified date: November 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: October 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Combined program
Combined program with physiotherapy, endurance training and resistance training
• Physiotherapy in private practice
Physiotherapy in private practice

Locations

Country	Name	City	State
France	Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE	Garches	Hauts DE Seine

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	20 Minutes
Secondary	Aerobic capacity	Aerobic capacity (V02 max)	1h
Secondary	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	45 min
Secondary	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.	45 min
Secondary	Balance (Berg Balance scale) and postural control assessment		15 min
Secondary	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)	55 min