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- Ensaio Clínico NCT03271125
Intensive Multimodal Training for Persons With MS (Treadmill)
Intensive Multimodal Training for Persons With Multiple Sclerosis: Random Controlled Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Persons with multiple sclerosis can have various deficits, affecting many aspects of physical and cognitive functioning often leading to low levels of physical activity in daily life. These include poor endurance, muscle weakness, incoordination and poor balance and cognitive deficits that can all lead to persistent mobility difficulties in daily life.
Given the importance of exercise and physical activity for persons with multiple sclerosis that are already moderately to severely hampered by their locomotor ability and balance, the setting up of intense functional mobility training that targets the main deficits, in adjunction to a clinical rehabilitation usual care and under close supervision, may be a viable way of increasing the level of physiological health and give a basis for the persons to start their own activity pursuit outside of the rehabilitation clinic. Treadmill walking has several benefits for mobility rehabilitation. First, it is a everyday task, walking. Second it lends itself well to a dual task paradigm where other aspects of mobility, such as equilibrium and cognitive factors can be addressed during walking. Third, even persons with severe walking limitations can train walking at various speeds when on treadmill, holding onto handrails and using safety harnesses that minimize the possibility of adverse events during training. Further, the treadmill paradigm lends itself well to training with progressive task difficulty, numerous rhythmic repetitions, and importantly it can include an aerobic component to improve cardiorespiratory fitness. All of which should lead to improved submaximal exercise tolerance and endurance, more functional mobility and consequently increased ability to carry out activities of daily living.
Methods: A consecutive sample of 42 People with Multiple Sclerosis (PwMS) were recruited from the outpatient/inpatient rehabilitation service of the Don Gnocchi Foundation. The study was conducted in accordance with the Declaration of Helsinki and was approved by the ethics committee of the Don Gnocchi Foundation. Subjects signed an informed consent form before the beginning of the study.
The study design was a two arm randomized 2:1 controlled trial (see study flow chart in Figure 1).
The participants were assessed before and after the rehabilitation period by researchers blinded to group assignment.
Participants in both groups received 15- 20 treatments sessions lasting 30 minutes 5 times per week by experienced physical therapists trained for the study. All participants also followed their usual rehabilitation care protocols as planned.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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MI
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Milan, MI, Itália, 20148
- Fondazione Don Carlo Gnocchi IRCCS
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Diagnosis of multiple sclerosis according to McDonald's criteria (Polman et al. Ann Neurology 2011)
- EDSS score <= 7
- Free from relapses and steroid treatment for at least 1 month)
- Able to stand 30 seconds,
- Able to walk at least 10 meters independently or with a cane
- Able to understand and follow instructions
- Stable neurological conditions and willingness to participate in the study.
Exclusion Criteria:
- Cardiac pacemaker
- Any pre-existing conditions that affected walking function
- diagnosis of depression or psychotic disorder
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Treadmill group
Participants in the experimental group received supervised treadmill training
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Participants in the experimental group received supervised treadmill training, 4-5 sessions per week.
The treatment protocol was aimed at improving participants' resistance, walking velocity, balance and cognitive functions during motor and cognitive (dual) tasks.
The treadmill training was carried out without body weight support but if needed the participants were attached to a safety harness.
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Comparador Ativo: Resistance group
Participants in the control group were treated with Resistance exercises.
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Participants in the control group were treated with Resistance exercises, 4-5 sessions per week.
The treatment protocol was aimed at improving strength in muscles involved in walking (hip abductors, quadriceps, plantar flexors, dorsal flexors) according to current guidelines from the American College of Sports Medicine (2009).
Three sets of 10 repetitions were performed bilaterally with appropriate weights for each exercise
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Two minute walking test
Prazo: Two minutes
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The subjects were instructed to walk at their usual speed for 2 minutes while the distance they covered in 2 minutes was recorded in meters.
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Two minutes
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Timed up and go test
Prazo: 1 minute
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The Timed Up & Go test (TUG) is a simple functional test that requires a person to stand up, walk 3m, turn back, and sit down again while being timed.
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1 minute
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
The Frontal Assessment Battery
Prazo: 10 minutes
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The Frontal Assessment Battery (FAB) is a short cognitive and behavioral six-subtest battery for the bedside screening of a global executive dysfunction.
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10 minutes
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Ten meter walking test
Prazo: 2 minutes
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The 10 meters walking test (10MWT) is a test in which the participant is timed while walking 10m at their comfortable speed.
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2 minutes
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The Berg Balance Scale
Prazo: 15 minutes
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The Berg Balance Scale (BBS) is a 14-item scale widely used to assess balance disorders in PwMS.
BBS provides information about patient's balance-related abilities.
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15 minutes
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Dynamic Gait Index
Prazo: 15 minutes
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The Dynamic Gait Index (DGI) measures gait function and dynamic balance.
The eight tasks of this scale include walking, walking with head turns, pivoting, walking over objects, walking around objects, and going upstairs.
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15 minutes
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The Short Form-12 questionnaire (SF-12)
Prazo: 10 minutes
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The SF12 is comprised of two domains, physical and mental and gives two composite scores that reflect the perceived health of the participant.
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10 minutes
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Treadmill MS
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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Ensaios clínicos em Treadmill
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Assaf-Harofeh Medical CenterBen-Gurion University of the NegevDesconhecidoParalisia Cerebral (PC)Israel