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

27 gennaio 2015 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Anticipato)

60

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Adult patients diagnosed with MS since at least 3 months

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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)
Altro: Rehabilitation
Physiotherapy and physical activity

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Assessment of the strength and fatigue
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
6 minutes walking test
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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),
Lasso di tempo: Within 10 weeks from the start of the rehabilitation program
Within 10 weeks from the start of the rehabilitation program
10 meters Walk test
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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),
Lasso di tempo: 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
Lasso di tempo: Within 10 weeks from the start of the rehabilitation
Within 10 weeks from the start of the rehabilitation
Assessment of the balance of patients
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigatori

  • Investigatore principale: Djamel Bensmail, MD,PhD, Physical and Rehabilitation Medicine department, Raymond Poincaré Hospital,
  • Direttore dello studio: Raphael Zory, PhD, LAMHESS Laboratory, Faculty of Sports Science, 06205 Nice, France
  • Direttore dello studio: Sophie Hameau, Physical and Rehabilitation Medicine department, Raymond Poincaré Hospital,

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2014

Completamento primario (Anticipato)

1 luglio 2015

Completamento dello studio (Anticipato)

1 ottobre 2015

Date di iscrizione allo studio

Primo inviato

20 gennaio 2015

Primo inviato che soddisfa i criteri di controllo qualità

27 gennaio 2015

Primo Inserito (Stima)

2 febbraio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

2 febbraio 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 gennaio 2015

Ultimo verificato

1 maggio 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 14-REHABSEP

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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