Physical Capacity and Rehabilitation of Patients With Multiple Sclerosis (REHABSEP)

Observational Study of the Physical Capacity of Patients With Multiple Sclerosis and Evaluation of the Effects of Usual Rehabilitation in the Day Hospital

The purpose of this study is to assess the physical capacity of patients with multiple sclerosis and the effects of rehabilitation, encompassing physical therapy and physical activity as it is carried out in the day hospital of (the Physical and Rehabilitation Medicine department) at Garches Hospital. We will compare the results of assessments carried out before and after a standard rehabilitation program.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis (MS)
• Intervention / Treatment: Other: Rehabilitation

Detailed Description

Single center, retrospective and prospective study.

In order to assess the efficiency of the of usual rehabilitation proposed to patients in the day hospital, assessments are systematically performed before and after the rehabilitation program:

1. Assessment of muscular strength and fatigue:

   Assessments of voluntary force will be those usually performed in the context of the evaluation of patients. The isokinetic dynamometer CON-TREX ® is a device that provides a quantified result of the torque developed in a predetermined joint area with a constant speed which is also defined in advance.

   The assessment includes an assessment of the strength in isometric contraction (at 40 and 90 degrees of knee flexion) and concentric contraction (30, 60 and 90 degrees per second). Fatigue is evaluated by two self-administered questionnaires: the Fatigue Severity Scale and Modified Fatigue Impact Scale.

2. Effort test:

   The aerobic capacity of patients will be assessed by a triangular maximal exercise test.

   The effort test is performed on a cycle ergometer from a triangular incremental exercise. Beforehand, blood pressure and ECG are recorded to establish that the patient can safely achieve a gradual stress test. Heart rate, blood pressure, oxygen consumption, the feeling (Borg scale) and ECG are recorded immediately before and immediately after the end of the test and every minute for at least 5-10 minutes during the recovery phase.

3. Clinical assessment:

The Timed Up and Go test will be used to assess the patient's capacity of postural transition.

This is a timed quantitative assessment of the duration needed to change from sitting in a chair, get up and walk three meters, make a U-turn and come back to sit down.

The 10 meters test quantifies the walking speed of patients (meters / second) over 10 meters A test of ascending and descending10 stairs is also performed, as well as the 6 minutes walking test.

In addition to these functional assessments, clinical tests are conventionally performed such as the measurement of muscle strength (Medical Research Council scale), range of motion, spasticity (modified Ashworth scale) and an assessment of the balance and posture.

The SEP-59 questionnaire will be used to assess the patients quality of life.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• France
  • Garches, France, 92380
    • Recruiting
    • Raymond Poincaré Hospital
    • Contact: Djamel Bensmail, MD,PhD; Phone Number: +33147107060; Email: djamel.bensmail@rpc.aphp.fr
    • Contact: Hameau Sophie; Phone Number: +33171144921; Email: sophie.hameau@rpc.aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with MS since at least 3 months

Description

Inclusion Criteria:

• Multiple Sclerosis with EDSS ≤ 6 (Expanded Disability Status Scale)
• Patient ≥ 18 years old
• Patient able to comply with the recommended monitoring
• No relapse within the last three months
• More than six months elapsed since last medical care in day hospital
• No recent modification (six month) of medications for MS
• More than three months elapsed since last change of associated treatments (Fampyra, botulinum toxin)

Exclusion Criteria:

• Patients under any form of guardianship or curatorship
• Breastfeeding
• Orthopedic complications with repercussions on walking activities
• No affiliation to a social security scheme (beneficiary or assignee)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Assessment; One part of this study is to quantify physical capacity of patients with Multiple sclerosis. Thirty patients will be enrolled in this study and performed assessments.
Rehabilitation; A second part of this study is to quantify the benefit of a usual rehabilitation program in the day hospital. Thirty patients will be enrolled in this study and receive rehabilitation. They will be assessed before and after the rehabilitation program (physiotherapy and physical activity)	Other: Rehabilitation; Physiotherapy and physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the strength and fatigue	Assessment realised with an isokinetic dynamometer	Within 10 weeks from the start of the rehabilitation program

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minutes walking test	Patients were instructed to walk as far as possible in a 50 meters corridor during 6 minutes	Within 10 weeks from the start of the rehabilitation program
Evaluation of aerobic capacity during an effort test	Aerobic capacity (VO2max)	Within 10 weeks from the start of the rehabilitation program
Assessment of the balance of patients	Berg Balance Scale	Within 10 weeks from the start of the rehabilitation program
Assessment of Spasticity with the Modified Ashworth Scale (MAS),		Within 10 weeks from the start of the rehabilitation program
10 meters Walk test	Patients have to walk over a 14 meter walkway and time required to traverse the middle 10 meters of the walk was recorded to avoid acceleration and deceleration effects	Within 10 weeks from the start of the rehabilitation
Timed up and go test	Patients have to get up from a chair, walk 3 meters, turn around and return to sitting as quickly as possible	Within 10 weeks from the start of the rehabilitation
Time to ascend and descend stairs	Participants were instructed to ascend and descend 10 stairs using the hand rail	Within 10 weeks from the start of the rehabilitation
Assessment of Strength with the Medical Research Council (MRC),		Within 10 weeks from the start of the rehabilitation
Assessment of Quality of Life with SEP-59 Scale		Within 10 weeks from the start of the rehabilitation
Assessment of the balance of patients	Postural control assessment : eyes opened and eyes closed	Within 10 weeks from the start of the rehabilitation

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Djamel Bensmail, MD,PhD, Physical and Rehabilitation Medicine department, Raymond Poincaré Hospital,; Study Director: Raphael Zory, PhD, LAMHESS Laboratory, Faculty of Sports Science, 06205 Nice, France; Study Director: Sophie Hameau, Physical and Rehabilitation Medicine department, Raymond Poincaré Hospital,

Publications and helpful links

General Publications

• Hameau S, Bensmail D, Roche N, Zory R. Fatigability in Patients With Multiple Sclerosis During Maximal Concentric Contractions. Arch Phys Med Rehabil. 2017 Jul;98(7):1339-1347. doi: 10.1016/j.apmr.2016.12.014. Epub 2017 Jan 25.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: January 20, 2015
• First Submitted That Met QC Criteria: January 27, 2015
• First Posted (Estimate): February 2, 2015

Study Record Updates

• Last Update Posted (Estimate): February 2, 2015
• Last Update Submitted That Met QC Criteria: January 27, 2015
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Multiple Sclerosis, Physical therapy, Physical capacity, Fatigue
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 14-REHABSEP