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

27 de janeiro de 2015 atualizado por: 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.

Visão geral do estudo

Status

Desconhecido

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Observacional

Inscrição (Antecipado)

60

Contactos e Locais

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Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Adult patients diagnosed with MS since at least 3 months

Descrição

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)

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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)
Outro: Rehabilitation
Physiotherapy and physical activity

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Assessment of the strength and fatigue
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
6 minutes walking test
Prazo: 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
Prazo: 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
Prazo: 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),
Prazo: Within 10 weeks from the start of the rehabilitation program
Within 10 weeks from the start of the rehabilitation program
10 meters Walk test
Prazo: 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
Prazo: 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
Prazo: 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),
Prazo: 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
Prazo: Within 10 weeks from the start of the rehabilitation
Within 10 weeks from the start of the rehabilitation
Assessment of the balance of patients
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Assistance Publique - Hôpitaux de Paris

Investigadores

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

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de julho de 2014

Conclusão Primária (Antecipado)

1 de julho de 2015

Conclusão do estudo (Antecipado)

1 de outubro de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

20 de janeiro de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de janeiro de 2015

Primeira postagem (Estimativa)

2 de fevereiro de 2015

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

2 de fevereiro de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de janeiro de 2015

Última verificação

1 de maio de 2014

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 14-REHABSEP

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