fNIRS for Monitoring Cortical Activity in Stroke Recovery
Functional Near-infrared Spectroscopy (fNIRS) is an Ideal Tool to Monitor Cortical Brain Activity and Understand the Mechanism Underlying Recovery Following Stroke
This clinical trial aims to investigate the mechanisms of brain reorganization underlying motor recovery following end-effector (EE) and exoskeleton (Exo) robot-assisted hand training in individuals with stroke. Using functional near-infrared spectroscopy (fNIRS), the study will (1) investigate brain activation patterns during EE and Exo robot-assisted hand movements in healthy adults and individuals with stroke and (2) examine longitudinal changes in brain activation and motor recovery over a 6-week intervention.
For Part 1, a cross-sectional observational study will be conducted to examine brain activation using fNIRS while participants perform EE and Exo robot-assisted movements. Healthy adults and individuals with stroke will each perform one session of each type of robot-assisted movement.
For Part 2, an evaluator-blinded randomized controlled design will be used. Participants will be stratified based on the level of motor impairment and the side of the brain lesion and then randomly assigned to either the EE or Exo robot-assisted training group. Both groups will receive training 3 times per week, with each session lasting 60 minutes, for a total of 6 weeks. Each session will include 40 minutes of robot-assisted therapy and 20 minutes of functional training.
Outcome assessments will be conducted at four time points: prior to the intervention (baseline), mid-intervention (during weeks 3-4 of the intervention), immediately after the intervention, and at the 3-month post-trial follow-up. These assessments will be used to evaluate motor recovery and longitudinal changes in brain function.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Chieh_ling Yang
- Número de telefone: 3058 03-2118800
- E-mail: chieh-ling.yang@cgu.edu.tw
Locais de estudo
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Taoyuan, Taiwan, 333
- Recrutamento
- Chang Gung Memorial Hospital
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Contato:
- Chieh-ling Yang
- Número de telefone: 3058 03-2118800
- E-mail: chieh-ling.yang@cgu.edu.tw
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Stroke participants
Inclusion Criteria:
- unilateral stroke onset ≥ 3 months
- Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score between 18 to 56 - modified Ashworth scale ≤ 3 in proximal joints and modified Ashworth scale ≤ 2 in distal joints
- able to follow 2-step instructions
- without excessive spasticity in any of the UE joints.
Exclusion Criteria:
- orthopedic conditions affecting the arm/hand or other neurological conditions
- severe pain that prevents movement in the affected arm and hand
- implanted cardiac pacemakers and cardioverter-defibrillators
- osteoporosis, fracture, or severe ataxia
- unstable medical status
- participating in other rehabilitation or drug studies simultaneously
- receiving Botulinum toxin injections within 3 months
Healthy participants
- have no neurological conditions
- have no musculoskeletal disorders affecting the UE
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: End-Effector (EE) robot-assisted training group
Robot-assisted therapy (EE system) and functional training
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Each group will receive intervention 3 times per week, 60 minutes per session, for a total duration of 6 weeks.
The intervention will consist of 40 minutes of robot-assisted therapy and 20 minutes of functional training.
For the robot-assisted therapy, participants will receive training using either the EE or EXO system according to group allocation.
The functional training component will be conducted without robotic assistance and will focus on task-oriented activities to facilitate the transfer of motor learning to functional performance.
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Experimental: Exoskeleton (EXO) robot-assisted training group.
Robot-assisted therapy (EXO system) and functional training
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Each group will receive intervention 3 times per week, 60 minutes per session, for a total duration of 6 weeks.
The intervention will consist of 40 minutes of robot-assisted therapy and 20 minutes of functional training.
For the robot-assisted therapy, participants will receive training using either the EE or EXO system according to group allocation.
The functional training component will be conducted without robotic assistance and will focus on task-oriented activities to facilitate the transfer of motor learning to functional performance.
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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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Task-related changes in oxyhemoglobin (HbO) concentration measured using functional near-infrared spectroscopy (fNIRS)
Prazo: Assessments will be conducted at baseline, mid-intervention (during weeks 3-4 of the intervention), immediately after the intervention, and at the 3-month post-trial follow-up.
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Cortical activation will be quantified as task-related changes in oxyhemoglobin (HbO) measured using functional near-infrared spectroscopy (fNIRS) during robot-assisted movements and upper extremity functional tasks (e.g., shoulder abduction, finger extension, and grasping).
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Assessments will be conducted at baseline, mid-intervention (during weeks 3-4 of the intervention), immediately after the intervention, and at the 3-month post-trial follow-up.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Chieh-ling Yang, Chang Gung University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 202400386B0
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