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

27. Januar 2015 aktualisiert von: 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.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

60

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Adult patients diagnosed with MS since at least 3 months

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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)
Sonstiges: Rehabilitation
Physiotherapy and physical activity

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Assessment of the strength and fatigue
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
6 minutes walking test
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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),
Zeitfenster: Within 10 weeks from the start of the rehabilitation program
Within 10 weeks from the start of the rehabilitation program
10 meters Walk test
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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),
Zeitfenster: 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
Zeitfenster: Within 10 weeks from the start of the rehabilitation
Within 10 weeks from the start of the rehabilitation
Assessment of the balance of patients
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Assistance Publique - Hôpitaux de Paris

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juli 2014

Primärer Abschluss (Voraussichtlich)

1. Juli 2015

Studienabschluss (Voraussichtlich)

1. Oktober 2015

Studienanmeldedaten

Zuerst eingereicht

20. Januar 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Januar 2015

Zuerst gepostet (Schätzen)

2. Februar 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

2. Februar 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Januar 2015

Zuletzt verifiziert

1. Mai 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 14-REHABSEP

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