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Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke

9 de junho de 2017 atualizado por: Roger Gassert
The aim of this project is to clinically evaluate a novel robot-assisted therapeutic approach to train sensorimotor hand function after stroke. It combines the profound experience of the clinic Hildebrand in neurocognitive therapy - involving brain and mind in the task and training both the motor and the sensory system - with the advanced haptic robotic technology of the Rehabilitation Engineering Lab at the Swiss Federal Institute of Technology Zurich (ETH Zurich), allowing unmet interaction with the hand through the simulation of virtual objects with various mechanical properties. In a randomized controlled clinical trial, 10 sub-acute stroke patients will receive four weeks of robotic therapy sessions, integrated seamlessly into their daily rehabilitation program, while 10 other patients will receive conventional therapy. The investigators will assess baseline performance in an initial clinical and robotic assessment, with another assessment at the end of the four-week period, and in follow-ups four weeks and six months later. The contents of the patient-tailored robotic therapy sessions will match those of the conventional therapy as closely as possible. This study will demonstrate the feasibility of including robotic therapy of hand function into the daily rehabilitation program, and investigate the acceptance from patients and therapists. The investigators expect increased training intensity during the robotic therapy session compared to conventional sessions with similar contents, as well as novel insights into the recovery process of both the motor and the sensory system during the four weeks of therapy, through advanced robotic assessments integrated into the training sessions. This project is a first step towards making such robotic therapy available to patients as integration into the conventional individual therapy program (e.g. for self-training), and towards transferring this technology to the home environment.

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Real)

34

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Ticino
      • Brissago, Ticino, Suíça, 6614
        • CLINICA HILDEBRAND CENTRO DI RIABILITAZIONE BRISSAGO

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 90 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • age between 18-90 years old
  • hemisyndrome (central paralysis of the upper extremity, and all degrees of weakness: M0 - M5 on the paresis scale) as a result of a first stroke
  • sub-acute lesion not more than 6 weeks post ictus

Exclusion Criteria:

  • insufficient state of consciousness
  • severe aphasia
  • severe cognitive deficits
  • severe pathologies of the upper extremity of traumatic or rheumatic nature
  • severe pain in the affected arm
  • Patients with pacemakers and other active implants

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

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
Experimental: Robot group

Receive robot-assisted neurocognitive therapy instead of conventional neurocognitive therapy.

(4 x 45 min/week)

2 degrees-of-freedom hand rehabilitation robot to train fine motor skills during grasping and forearm rotation.
Outros nomes:
  • Rehabilitation robot ReHapticKnob
Comparador Ativo: Control group
Receive dose-matched conventional neurocognitive therapy
Use sensory perception (tactile, proprioception but not vision!) to solve a by the therapist guided (passive) or patient controlled (active) therapy task, e.g. discrimination/identification of different spring resistances, sponges, different sized blocks, etc.
Outros nomes:
  • Perfetti-concept

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Motor impairment of the upper limb
Prazo: Change from Baseline in motor impairment of the upper limb at 4 weeks
Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points)
Change from Baseline in motor impairment of the upper limb at 4 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Motor impairment of the upper limb
Prazo: Change from Baseline in motor impairment of the upper limb at 8 weeks
Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points)
Change from Baseline in motor impairment of the upper limb at 8 weeks
Motor impairment of the upper limb
Prazo: Change from Baseline in motor impairment of the upper limb at 6 months
Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points)
Change from Baseline in motor impairment of the upper limb at 6 months
Functional improvement in dexterity
Prazo: Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks
Functional improvement in dexterity is assessed with the Box and Block Test
Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks
Functional improvement in dexterity
Prazo: Change from Baseline in functional improvement of dexterity of the upper limb at 8 weeks
Functional improvement in dexterity is assessed with the Box and Block Test
Change from Baseline in functional improvement of dexterity of the upper limb at 8 weeks
Functional improvement in dexterity
Prazo: Change from Baseline in functional improvement of dexterity of the upper limb at 6 months
Functional improvement in dexterity is assessed with the Box and Block Test
Change from Baseline in functional improvement of dexterity of the upper limb at 6 months
Spasticity level of the upper limb
Prazo: Change from Baseline in spasticity level of the upper limb at 4 weeks
Spasticity level is measured with the Modified Ashworth Scale
Change from Baseline in spasticity level of the upper limb at 4 weeks
Spasticity level of the upper limb
Prazo: Change from Baseline in spasticity level of the upper limb at 8 weeks
Spasticity level is measured with the Modified Ashworth Scale
Change from Baseline in spasticity level of the upper limb at 8 weeks
Spasticity level of the upper limb
Prazo: Change from Baseline in spasticity level of the upper limb at 6 months
Spasticity level is measured with the Modified Ashworth Scale
Change from Baseline in spasticity level of the upper limb at 6 months
Tactile and proprioceptive sensory function of the upper limb
Prazo: Change from Baseline in Tactile and proprioceptive sensory function of the upper limb at 4 weeks
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC (Medical Center) Nottingham Sensory Assessment
Change from Baseline in Tactile and proprioceptive sensory function of the upper limb at 4 weeks
Tactile and proprioceptive sensory function of the upper limb
Prazo: Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 8 weeks
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment
Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 8 weeks
Tactile and proprioceptive sensory function of the upper limb
Prazo: Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment
Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months
Neglect
Prazo: Change from Baseline in neglect at 4 weeks
Neglect is assessed with the Albert's test of neglect
Change from Baseline in neglect at 4 weeks
Neglect
Prazo: Change from Baseline in neglect at 8 weeks
Neglect is assessed with the Albert's test of neglect
Change from Baseline in neglect at 8 weeks
Neglect
Prazo: Change from Baseline in neglect at 6 months
Neglect is assessed with the Albert's test of neglect
Change from Baseline in neglect at 6 months
Cognitive impairment
Prazo: Change from Baseline in cognitive impairment at 4 weeks
Cognitive impairment is assessed with the Mini Mental State Examination
Change from Baseline in cognitive impairment at 4 weeks
Cognitive impairment
Prazo: Change from Baseline in cognitive impairment at 8 weeks
Cognitive impairment is assessed with the Mini Mental State Examination
Change from Baseline in cognitive impairment at 8 weeks
Cognitive impairment
Prazo: Change from Baseline in cognitive impairment at 6 months
Cognitive impairment is assessed with the Mini Mental State Examination
Change from Baseline in cognitive impairment at 6 months
Frontal lobe function
Prazo: Change from Baseline in frontal lobe function at 4 weeks
Frontal lobe function is assessed with the Frontal assessment battery
Change from Baseline in frontal lobe function at 4 weeks
Frontal lobe function
Prazo: Change from Baseline in frontal lobe function at 8 weeks
Frontal lobe function is assessed with the Frontal assessment battery
Change from Baseline in frontal lobe function at 8 weeks
Frontal lobe function
Prazo: Change from Baseline in frontal lobe function at 6 months
Frontal lobe function is assessed with the Frontal assessment battery
Change from Baseline in frontal lobe function at 6 months
Aphasia
Prazo: Change from Baseline in aphasia at 4 weeks
Aphasia is assessed with the Aachener Aphasia Test
Change from Baseline in aphasia at 4 weeks
Aphasia
Prazo: Change from Baseline in aphasia at 8 weeks
Aphasia is assessed with the Aachener Aphasia Test
Change from Baseline in aphasia at 8 weeks
Aphasia
Prazo: Change from Baseline in aphasia at 6 months
Aphasia is assessed with the Aachener Aphasia Test
Change from Baseline in aphasia at 6 months
Attention
Prazo: Change from Baseline in attention at 4 weeks
Attention is assessed with the test to identify attention
Change from Baseline in attention at 4 weeks
Attention
Prazo: Change from Baseline in attention at 8 weeks
Attention is assessed with the test to identify attention
Change from Baseline in attention at 8 weeks
Attention
Prazo: Change from Baseline in attention at 6 months
Attention is assessed with the test to identify attention
Change from Baseline in attention at 6 months

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Diretor de estudo: Roger Gassert, Prof. Dr., Rehabilitation Engineering Lab, ETH Zurich

Publicações e links úteis

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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 (Real)

1 de abril de 2013

Conclusão Primária (Real)

10 de março de 2017

Conclusão do estudo (Real)

9 de junho de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

19 de março de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de março de 2014

Primeira postagem (Estimativa)

26 de março de 2014

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de junho de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de junho de 2017

Última verificação

1 de junho de 2017

Mais Informações

Termos relacionados a este estudo

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