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Multiple Sclerosis (MS)REHABSEPNCT02352194

Physical Capacity and Rehabilitation of Patients With Multiple Sclerosis

An observational study of Multiple Sclerosis (MS), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Multiple Sclerosis (MS)
What is being tested?
Rehabilitation
How many people
60 participants
Where
1 siteFrance
Study dates
Jul 2014to Oct 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients diagnosed with MS since at least 3 months

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Djamel Bensmail, MD, PhD contact

+33147107060

djamel.bensmail@rpc.aphp.fr

France1 site, 1 recruiting

  • Raymond Poincaré Hospital

    Garches, 92380

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

    Hameau Sophie, +33171144921, sophie.hameau@rpc.aphp.fr

    Recruiting

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Rehabilitation
Keywords
Multiple Sclerosis, Physical therapy, Physical capacity, Fatigue
Medical subject headings
Multiple Sclerosis, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RehabilitationOther

    Physiotherapy and physical activity

Study groups in NCT02352194
Study groupRoleWhat they receive
AssessmentOne 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.
RehabilitationA 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)
Receives: Other: Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of the strength and fatigue

    Assessment realised with an isokinetic dynamometer

    Measured: Within 10 weeks from the start of the rehabilitation program

Secondary outcomes (10)

  1. 6 minutes walking test

    Patients were instructed to walk as far as possible in a 50 meters corridor during 6 minutes

    Measured: Within 10 weeks from the start of the rehabilitation program

  2. Evaluation of aerobic capacity during an effort test

    Aerobic capacity (VO2max)

    Measured: Within 10 weeks from the start of the rehabilitation program

  3. Assessment of the balance of patients

    Berg Balance Scale

    Measured: Within 10 weeks from the start of the rehabilitation program

  4. Assessment of Spasticity with the Modified Ashworth Scale (MAS),

    Measured: Within 10 weeks from the start of the rehabilitation program

  5. 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

    Measured: Within 10 weeks from the start of the rehabilitation

  6. 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

    Measured: Within 10 weeks from the start of the rehabilitation

  7. Time to ascend and descend stairs

    Participants were instructed to ascend and descend 10 stairs using the hand rail

    Measured: Within 10 weeks from the start of the rehabilitation

  8. Assessment of Strength with the Medical Research Council (MRC),

    Measured: Within 10 weeks from the start of the rehabilitation

  9. Assessment of Quality of Life with SEP-59 Scale

    Measured: Within 10 weeks from the start of the rehabilitation

  10. Assessment of the balance of patients

    Postural control assessment : eyes opened and eyes closed

    Measured: Within 10 weeks from the start of the rehabilitation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2015 (estimated)
  2. Study startJul 2014
  3. Primary completionJul 2015 (estimated)
  4. Study completionOct 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02352194
Sponsor's protocol ID
14-REHABSEP
Acronym
REHABSEP
Status last verified
May 2014
First submitted
20 Jan 2015
Last updated
2 Feb 2015
Results posted
No
Data monitoring committee
No

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.

    PubMed 28130080

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis (MS), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Djamel Bensmail, MD, PhD (+33147107060, djamel.bensmail@rpc.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of the strength and fatigue (time frame: Within 10 weeks from the start of the rehabilitation program). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02352194, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2015.

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