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Physical Capacity and Rehabilitation of Patients With Multiple Sclerosis

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02352194
Acronym
REHABSEP
Enrollment
60
Registered
2015-02-02
Start date
2014-07-31
Completion date
2015-10-31
Last updated
2015-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis (MS)

Keywords

Multiple Sclerosis, Physical therapy, Physical capacity, Fatigue

Brief 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.

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.

Interventions

OTHERRehabilitation

Physiotherapy and physical activity

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Assessment of the strength and fatigueWithin 10 weeks from the start of the rehabilitation programAssessment realised with an isokinetic dynamometer

Secondary

MeasureTime frameDescription
Evaluation of aerobic capacity during an effort testWithin 10 weeks from the start of the rehabilitation programAerobic capacity (VO2max)
Assessment of the balance of patientsWithin 10 weeks from the start of the rehabilitation programBerg Balance Scale
Assessment of Spasticity with the Modified Ashworth Scale (MAS),Within 10 weeks from the start of the rehabilitation program
10 meters Walk testWithin 10 weeks from the start of the rehabilitationPatients 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
6 minutes walking testWithin 10 weeks from the start of the rehabilitation programPatients were instructed to walk as far as possible in a 50 meters corridor during 6 minutes
Time to ascend and descend stairsWithin 10 weeks from the start of the rehabilitationParticipants were instructed to ascend and descend 10 stairs using the hand rail
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 ScaleWithin 10 weeks from the start of the rehabilitation
Timed up and go testWithin 10 weeks from the start of the rehabilitationPatients have to get up from a chair, walk 3 meters, turn around and return to sitting as quickly as possible

Countries

France

Contacts

Primary ContactDjamel Bensmail, MD, PhD
djamel.bensmail@rpc.aphp.fr+33147107060

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026