Effectiveness of Different Approaches for the Rehabilitation of Gait in Patients With Parkinson's Disease (Tr-T-VR)
Evaluation of the Effectiveness of Three Different Approaches for the Rehabilitation of Gait in Patients With Parkinson's Disease: Treadmill Versus Treadmill-plus Versus Virtual Reality
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Gait disorders represent one of principal hallmark of Parkinson's disease (PD). Typically, PD patients demonstrate reduced stride length and walking speed during free ambulation, while double support duration and cadence rate are increased. Gait disorders are generally poorly responsive to dopaminergic treatments and are related to reduced quality of life and augmented risk of falls. Different rehabilitation techniques based on compensatory and learning strategies, which principally exploit the use of cues to bypass the defective basal ganglia and to ameliorate performance through practice, have been demonstrated to be effective in improving gait in patients with PD. Cueing techniques represent the central core for the rehabilitation of parkinsonian gait. In this context, it has been demonstrated that treadmill training can improve gait performance in PD patients. It probably acts as an external cue exerting a normalizing effect on the spatiotemporal gait parameters and leading to an enhanced gait rhythmicity and a reduced gait variability. The use of a treadmill with visual and auditory cues (treadmill-plus) seems to lead to a better improvement in gait parameters when compared to treadmill alone. Recently, the application of virtual reality (VR) has been introduced in the rehabilitation of PD. The use of VR is based on the interaction of the person with a virtual environment with the aim to promote motor learning through enhanced perceptions (visual, auditory, and haptic inputs).
It has been widely demonstrated that a multidisciplinary, intensive, goal-based, motor-cognitive and aerobic treatment (MIRT), specifically designed for PD patients, provide parkinsonians with motor and functional benefits. Nevertheless, the contribution provided by treadmill, treadmill-plus and VR on gait parameters has not been previously addressed within MIRT.
This study aims at investigating the superiority or the non-inferiority of these different devices in improving gait in PD patients in the context of MIRT.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Como
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Gravedona ed Uniti, Como, Itália, 22015
- Recrutamento
- "Moriggia-Pelascini" Hospital
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Contato:
- Davide Ferrazzoli, MD
- Número de telefone: +393318643163
- E-mail: davideferrazzoli@gmail.com
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Contato:
- Ilaria Zivi, MD
- Número de telefone: +393805468322
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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 "probable" idiopathic Parkinson's disease according to Gelb et al (Gelb, 1999);
- Mild to moderate stage of disease (stage 2-3) according to Hoehn & Yahr scale;
- Ability to walk on treadmill;
- Visual and hearing capacity sufficient to perceive the cues;
- No cognitive impairment (Mini-Mental State Examination score ≥ 26);
- Stable pharmacological treatment since 2 weeks before admission and during rehabilitation;
Exclusion Criteria:
- Diagnosis of atypical or vascular Parkinsonism;
- Occurrence of cardiovascular, orthopaedic, peripheral nerves, musculoskeletal and vestibular disorders which could affect patient's locomotion or balance;
- Neuropsychiatric disturbances;
- Severe dyskinesia;
- Severe freezing of gait;
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: MIRT + Treadmill
In the context of MIRT, the gait training in this group will be performed by using a treadmill without cues.
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PD patients will undergo a 4-week MIRT.
All patients in the MIRT+Treadmill Plus group will undergo 10-minutes treadmill training twice per day, 5 times a week, for 4 weeks.
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Experimental: MIRT + Treadmill Plus
In the context of MIRT, the gait training in this group will be performed by using a treadmill with visual and auditory cues.
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PD patients will undergo a 4-week MIRT.
All patients in the MIRT+Treadmill Plus group will undergo 10-minutes treadmill-plus training (with visual and auditory cues) twice per day, 5 times a week, for 4 weeks.
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Experimental: MIRT + Virtual Reality
In the context of MIRT, the gait training in this group will be performed by using Virtual Reality with enhanced perceptions (visual, auditory, and haptic inputs).
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PD patients will undergo a 4-week MIRT.
All patients in the MIRT+Virtual Reality (VR) group will undergo 10-minutes VR training with enhanced perceptions (visual, auditory, and haptic inputs), twice per day, 5 times a week, for 4 weeks.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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6-minute walking test (6MWT)
Prazo: 4 weeks
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Patient is first familiarized with the test by letting him/her go once forward and backward along a straight 15-m line on the ground in a gymnasium.
Then, after 15 minutes rest, he/she is instructed to walk from end to end of the line for 6 minutes and to cover as much distance as possible.
No encouragement is offered during the test and no cues are used.
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4 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Average length of right and left steps
Prazo: 4 weeks
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The average length of right and left steps (expressed in centimetres and calculated by averaging the length of all the right steps and left steps, respectively).
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4 weeks
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Coefficient of variance
Prazo: 4 weeks
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coefficient of variance (CoV) of both right and left steps (which expresses the amount of variation occurring between footfalls).
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4 weeks
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Step cycle
Prazo: 4 weeks
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Step cycle (cycle/s), calculated by averaging the step cycles during the exercise.
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4 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Frazzitta Giuseppe, MD, "Moriggia-Pelascini" Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- OGZonaMP-PD Gait Rehab
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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