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

27. januar 2015 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

60

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Adult patients diagnosed with MS since at least 3 months

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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)
Annen: Rehabilitation
Physiotherapy and physical activity

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Assessment of the strength and fatigue
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
6 minutes walking test
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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),
Tidsramme: Within 10 weeks from the start of the rehabilitation program
Within 10 weeks from the start of the rehabilitation program
10 meters Walk test
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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),
Tidsramme: 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
Tidsramme: Within 10 weeks from the start of the rehabilitation
Within 10 weeks from the start of the rehabilitation
Assessment of the balance of patients
Tidsramme: 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

Samarbeidspartnere og etterforskere

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Sponsor

Assistance Publique - Hôpitaux de Paris

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2014

Primær fullføring (Forventet)

1. juli 2015

Studiet fullført (Forventet)

1. oktober 2015

Datoer for studieregistrering

Først innsendt

20. januar 2015

Først innsendt som oppfylte QC-kriteriene

27. januar 2015

Først lagt ut (Anslag)

2. februar 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

2. februar 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. januar 2015

Sist bekreftet

1. mai 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 14-REHABSEP

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