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

27 janvier 2015 mis à jour par: Assistance Publique - Hôpitaux de Paris

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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Anticipé)

60

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Adult patients diagnosed with MS since at least 3 months

La 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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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)
Autre: Rehabilitation
Physiotherapy and physical activity

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Assessment of the strength and fatigue
Délai: Within 10 weeks from the start of the rehabilitation program
Assessment realised with an isokinetic dynamometer
Within 10 weeks from the start of the rehabilitation program

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
6 minutes walking test
Délai: 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
Within 10 weeks from the start of the rehabilitation program
Evaluation of aerobic capacity during an effort test
Délai: Within 10 weeks from the start of the rehabilitation program
Aerobic capacity (VO2max)
Within 10 weeks from the start of the rehabilitation program
Assessment of the balance of patients
Délai: Within 10 weeks from the start of the rehabilitation program
Berg Balance Scale
Within 10 weeks from the start of the rehabilitation program
Assessment of Spasticity with the Modified Ashworth Scale (MAS),
Délai: Within 10 weeks from the start of the rehabilitation program
Within 10 weeks from the start of the rehabilitation program
10 meters Walk test
Délai: 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
Within 10 weeks from the start of the rehabilitation
Timed up and go test
Délai: 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
Within 10 weeks from the start of the rehabilitation
Time to ascend and descend stairs
Délai: Within 10 weeks from the start of the rehabilitation
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),
Délai: Within 10 weeks from the start of the rehabilitation
Within 10 weeks from the start of the rehabilitation
Assessment of Quality of Life with SEP-59 Scale
Délai: Within 10 weeks from the start of the rehabilitation
Within 10 weeks from the start of the rehabilitation
Assessment of the balance of patients
Délai: Within 10 weeks from the start of the rehabilitation
Postural control assessment : eyes opened and eyes closed
Within 10 weeks from the start of the rehabilitation

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Assistance Publique - Hôpitaux de Paris

Les enquêteurs

  • Chercheur principal: Djamel Bensmail, MD,PhD, Physical and Rehabilitation Medicine department, Raymond Poincaré Hospital,
  • Directeur d'études: Raphael Zory, PhD, LAMHESS Laboratory, Faculty of Sports Science, 06205 Nice, France
  • Directeur d'études: Sophie Hameau, Physical and Rehabilitation Medicine department, Raymond Poincaré Hospital,

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juillet 2014

Achèvement primaire (Anticipé)

1 juillet 2015

Achèvement de l'étude (Anticipé)

1 octobre 2015

Dates d'inscription aux études

Première soumission

20 janvier 2015

Première soumission répondant aux critères de contrôle qualité

27 janvier 2015

Première publication (Estimation)

2 février 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

2 février 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 janvier 2015

Dernière vérification

1 mai 2014

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 14-REHABSEP

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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