Physical Capacity and Rehabilitation of Patients With Multiple Sclerosis

Multiple Sclerosis (MS) Clinical Trial

— REHABSEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02352194
• Other study ID #: 14-REHABSEP
• Status: Recruiting
• Phase: N/A
• First received: January 20, 2015
• Last updated: January 27, 2015
• Start date: July 2014
• Est. completion date: October 2015

Study information

• Verified date: May 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Djamel Bensmail, MD, PhD
• Phone: +33147107060
• Email: djamel.bensmail[@]rpc.aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis (MS)
• Sclerosis

Intervention

Other:
• Rehabilitation
Physiotherapy and physical activity

Locations

Country	Name	City	State
France	Raymond Poincaré Hospital	Garches

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	Assessment of the strength and fatigue	Assessment realised with an isokinetic dynamometer	Within 10 weeks from the start of the rehabilitation program	No
Secondary	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	No
Secondary	Evaluation of aerobic capacity during an effort test	Aerobic capacity (VO2max)	Within 10 weeks from the start of the rehabilitation program	No
Secondary	Assessment of the balance of patients	Berg Balance Scale	Within 10 weeks from the start of the rehabilitation program	No
Secondary	Assessment of Spasticity with the Modified Ashworth Scale (MAS),		Within 10 weeks from the start of the rehabilitation program	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Assessment of Strength with the Medical Research Council (MRC),		Within 10 weeks from the start of the rehabilitation	No
Secondary	Assessment of Quality of Life with SEP-59 Scale		Within 10 weeks from the start of the rehabilitation	No
Secondary	Assessment of the balance of patients	Postural control assessment : eyes opened and eyes closed	Within 10 weeks from the start of the rehabilitation	No