Physical Capacity and Rehabilitation of Patients With Multiple Sclerosis (REHABSEP)
|ClinicalTrials.gov Identifier: NCT02352194|
Recruitment Status : Unknown
Verified May 2014 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Recruiting
First Posted : February 2, 2015
Last Update Posted : February 2, 2015
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis (MS)||Other: Rehabilitation|
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:
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.
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.
- 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|
|Estimated Enrollment :||60 participants|
|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|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||October 2015|
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.
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)
Physiotherapy and physical activity
- Assessment of the strength and fatigue [ Time Frame: Within 10 weeks from the start of the rehabilitation program ]Assessment realised with an isokinetic dynamometer
- 6 minutes walking test [ Time Frame: Within 10 weeks from the start of the rehabilitation program ]Patients were instructed to walk as far as possible in a 50 meters corridor during 6 minutes
- Evaluation of aerobic capacity during an effort test [ Time Frame: Within 10 weeks from the start of the rehabilitation program ]Aerobic capacity (VO2max)
- Assessment of the balance of patients [ Time Frame: Within 10 weeks from the start of the rehabilitation program ]Berg Balance Scale
- Assessment of Spasticity with the Modified Ashworth Scale (MAS), [ Time Frame: Within 10 weeks from the start of the rehabilitation program ]
- 10 meters Walk test [ Time Frame: Within 10 weeks from the start of the rehabilitation ]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
- Timed up and go test [ Time Frame: Within 10 weeks from the start of the rehabilitation ]Patients have to get up from a chair, walk 3 meters, turn around and return to sitting as quickly as possible
- Time to ascend and descend stairs [ Time Frame: Within 10 weeks from the start of the rehabilitation ]Participants were instructed to ascend and descend 10 stairs using the hand rail
- Assessment of Strength with the Medical Research Council (MRC), [ Time Frame: Within 10 weeks from the start of the rehabilitation ]
- Assessment of Quality of Life with SEP-59 Scale [ Time Frame: Within 10 weeks from the start of the rehabilitation ]
- Assessment of the balance of patients [ Time Frame: Within 10 weeks from the start of the rehabilitation ]Postural control assessment : eyes opened and eyes closed
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352194
|Contact: Djamel Bensmail, MD, PhDfirstname.lastname@example.org|
|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,|