Physical Capacity and Rehabilitation of Patients With Multiple Sclerosis (REHABSEP)
Observational Study of the Physical Capacity of Patients With Multiple Sclerosis and Evaluation of the Effects of Usual Rehabilitation in the Day Hospital
Přehled studie
Detailní popis
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:
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.
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.
- 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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
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Garches, Francie, 92380
- Nábor
- Raymond Poincaré Hospital
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Kontakt:
- Djamel Bensmail, MD,PhD
- Telefonní číslo: +33147107060
- E-mail: djamel.bensmail@rpc.aphp.fr
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Kontakt:
- Hameau Sophie
- Telefonní číslo: +33171144921
- E-mail: sophie.hameau@rpc.aphp.fr
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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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. |
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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)
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Physiotherapy and physical activity
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Assessment of the strength and fatigue
Časové okno: Within 10 weeks from the start of the rehabilitation program
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Assessment realised with an isokinetic dynamometer
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Within 10 weeks from the start of the rehabilitation program
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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6 minutes walking test
Časové okno: Within 10 weeks from the start of the rehabilitation program
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Patients were instructed to walk as far as possible in a 50 meters corridor during 6 minutes
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Within 10 weeks from the start of the rehabilitation program
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Evaluation of aerobic capacity during an effort test
Časové okno: Within 10 weeks from the start of the rehabilitation program
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Aerobic capacity (VO2max)
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Within 10 weeks from the start of the rehabilitation program
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Assessment of the balance of patients
Časové okno: Within 10 weeks from the start of the rehabilitation program
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Berg Balance Scale
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Within 10 weeks from the start of the rehabilitation program
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Assessment of Spasticity with the Modified Ashworth Scale (MAS),
Časové okno: Within 10 weeks from the start of the rehabilitation program
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Within 10 weeks from the start of the rehabilitation program
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10 meters Walk test
Časové okno: Within 10 weeks from the start of the rehabilitation
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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
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Within 10 weeks from the start of the rehabilitation
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Timed up and go test
Časové okno: Within 10 weeks from the start of the rehabilitation
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Patients have to get up from a chair, walk 3 meters, turn around and return to sitting as quickly as possible
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Within 10 weeks from the start of the rehabilitation
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Time to ascend and descend stairs
Časové okno: Within 10 weeks from the start of the rehabilitation
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Participants were instructed to ascend and descend 10 stairs using the hand rail
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Within 10 weeks from the start of the rehabilitation
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Assessment of Strength with the Medical Research Council (MRC),
Časové okno: Within 10 weeks from the start of the rehabilitation
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Within 10 weeks from the start of the rehabilitation
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Assessment of Quality of Life with SEP-59 Scale
Časové okno: Within 10 weeks from the start of the rehabilitation
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Within 10 weeks from the start of the rehabilitation
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Assessment of the balance of patients
Časové okno: Within 10 weeks from the start of the rehabilitation
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Postural control assessment : eyes opened and eyes closed
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Within 10 weeks from the start of the rehabilitation
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Djamel Bensmail, MD,PhD, Physical and Rehabilitation Medicine department, Raymond Poincaré Hospital,
- Ředitel studie: Raphael Zory, PhD, LAMHESS Laboratory, Faculty of Sports Science, 06205 Nice, France
- Ředitel studie: Sophie Hameau, Physical and Rehabilitation Medicine department, Raymond Poincaré Hospital,
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 14-REHABSEP
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