Reabilitação de Melhoria da Coordenação Neuro-Muscular Guiada por EMG (NICE) Através da Interação Homem-Máquina (NICE)
15 de junho de 2026 atualizado por: Jinsook Roh, University of Houston
Reabilitação de Melhoria da Coordenação Neuro-Inter-Muscular (NICE)
O objetivo deste estudo é desenvolver a reabilitação Neuro-Intermuscular Coordination Enhancement (NICE), uma nova estratégia guiada por sinais de controlo neuromuscular que orienta visualmente os doentes com AVC para ativar individualmente grupos de músculos sinergéticos através da interação homem-máquina.
Em última análise, o desenvolvimento levará a uma melhor recuperação motora clínica, a uma melhor qualidade de vida e à redução dos custos de saúde associados à deficiência.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Descrição detalhada
O acidente vascular cerebral é a principal causa de incapacidade grave a longo prazo, afetando 9,4 milhões de americanos. Todos os anos, cerca de 800.000 pessoas sofrem um AVC, mesmo nos EUA. A deficiência motora crónica do membro superior é um fator importante que contribui para a incapacidade; o uso funcional do membro superior afetado na vida diária é um fator-chave para aumentar a independência, o regresso ao trabalho e a qualidade de vida em geral. Assim, um tratamento eficaz e inovador para abordar a incapacidade a longo prazo é tanto uma necessidade importante de saúde pública como uma necessidade económica.
O estudo desenvolverá uma plataforma inovadora de interação homem-máquina para direcionar e melhorar a coordenação interarticular e a função motora, melhorando a coordenação muscular no membro superior. Este estudo, no total, 38 sobreviventes de AVC crónico serão aleatoriamente distribuídos por duas estratégias de reabilitação: exercício guiado por coordenação neuromuscular (NICE; grupo de terapia) ou exercício guiado por força (grupo de controlo). Os critérios de inclusão consistem principalmente em: (1) ter sofrido um AVC isquémico ou hemorrágico pelo menos 6 meses antes (AVC crónico); (2) ter entre 21 e 80 anos de idade; (3) não ter recebido tratamento com toxina botulínica no braço afetado nos últimos 3 meses; e (4) não ter deficiências cognitivas que afetem a compreensão das tarefas ou a capacidade de dar consentimento informado.
Este estudo avaliará os efeitos de ambos os exercícios de reabilitação na coordenação muscular, nas pontuações clínicas padronizadas, na cinética e no eletroencefalograma.
Tipo de estudo
Intervencional
Inscrição (Estimado)
48
Estágio
- Fase inicial 1
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.
Contato de estudo
- Nome: Jinsook Roh, PhD
- Número de telefone: 7137432578
- E-mail: jroh@Central.UH.EDU
Locais de estudo
-
-
Texas
-
Houston, Texas, Estados Unidos, 77045
- University of Houston
-
Contato:
- JIN-SOOK ROH, PhD
- Número de telefone: 6173680050
- E-mail: jsroh@central.uh.edu
-
Investigador principal:
- Jinsook Roh, PhD
-
-
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
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
Critérios de Inclusão:
- Acidente vascular cerebral isquémico ou hemorrágico
- Idade entre 21 e 80 anos
- Não estar a receber toxina botulínica no braço afetado nos últimos 3 meses
- MAS ≤ 3 à volta do cotovelo e ombro
Critérios de Exclusão:
- ter uma perturbação ortopédica envolvendo os membros superiores;
- défice cognitivo suficiente para interferir com o consentimento informado ou a conclusão bem-sucedida do protocolo (pontuação no Montreal Cognitive Assessment (MoCA) ≤ 26);
- historial de outra doença neurológica;
- anestesia do sentido de posição articular nos membros superiores;
- estar grávida ou haver possibilidade de o estar (auto-declarado);
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: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Neuromuscular coordination enhancement (NICE) intervention
Post-stroke participants will perform a center-out task by activating individual motor modules (generating coordinated isometric contractions of muscles) to move the cursor on a screen while electromyographic (EMG) signals are recorded.
Activation of each muscle (or muscle group) will be mapped to 1 of 4 directions within the multi-dimensional cursor space.
We will derive the cursor position in real time using Motor module activation magnitudes recorded from arm muscles.
|
Neuro-Intermuscular Coordination Enhancement (NICE) is a motor module-guided rehabilitation intervention designed to improve upper-extremity motor recovery after stroke by retraining impaired intermuscular coordination patterns. Participants perform isometric upper-extremity force-generation tasks using a human-machine interface while receiving real-time visual feedback derived from motor module recruitment signals calculated from surface electromyography (EMG). Individualized motor module targets are derived from the participant's less-affected upper extremity and used to guide selective recruitment of impaired coordination patterns in the more-affected upper extremity. Participants will complete 18 one-hour training sessions over six weeks (3 sessions/week). During training, participants perform repetitive target-matching tasks that require preferential recruitment of specific motor modules while minimizing unintended activation of non-target modules. |
|
Comparador Ativo: EMG-amplitude biofeedback exercise
Participants will perform a center-out target matching tasks where individual muscle EMGs are used to move a cursor on the visual feedback display to match one of 4 different targets presented to them.
Here, just the EMG amplitude, and not the coordination is focused on.
|
EMG Amplitude Biofeedback Exercise is an active comparator rehabilitation intervention designed to improve upper-extremity motor function after stroke through targeted muscle activation training.
Participants perform isometric upper-extremity exercises using a human-machine interface with real-time EMG amplitude-based visual feedback.
Individualized muscle activation targets derived from the less-affected upper extremity guide training of the more-affected upper extremity.
Participants will complete 18 one-hour sessions over 6 weeks (3 sessions/week).
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Fugl-Meyer Assessment (FMA) score
Prazo: Baseline, six- week, 10-week, and 18-week follow-ups.
|
Motor impairment after stroke will be measured by upper extremity FMA (UE-FMA).
The maximum UE-FMA motor score is 66 (i.e., 0: complete motor impairment; 66: normal motor performance).
Each item is scored on a 3-point scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).
The FMA score reflects the level of upper extremity motor impairment.
|
Baseline, six- week, 10-week, and 18-week follow-ups.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Similarity Score of Intermuscular Coordination Patterns (or Motor Modules)
Prazo: Baseline, six- week, 10-week, and 18-week follow-ups.
|
Surface EMGs will be recorded from 8 key arm muscles during a 54-target isometric force generation task.
A dimensionality reduction method (non-negative matrix factorization (NNMF)) will be applied to identify intermuscular coordination patterns - operational definition of motor modules in the field of motor neuroscience.
They are mathematically 8-dimensional unit vectors.
Similarity score is the scalar product (or dot product) between a pair of intermuscular coordination patterns in comparison (i.e., motor modules).
We compute the similarity score between the less-affected and the more-affected arms.
Also, surface EMGs will be recorded from 8 key arm muscles during 3D dynamic reaching tasks.
NNMF will be applied to EMGs to identify and compare intermuscular coordination patterns.
Similarity score is the scalar product between motor modules (i.e., intermuscular coordination patters) of the more-affected arm in stroke group and dominant arm in healthy group.
|
Baseline, six- week, 10-week, and 18-week follow-ups.
|
|
Kinematic Synergy Similarity Score
Prazo: Baseline, six-week, 10-week, and 18-week follow-ups.
|
Kinematic synergies are a representation of multi-joint coordination.
It will be identified using NNMF algorithm applied to the joint kinematic data obtained from 3D dynamic point-to-point reaching tasks.
Kinematic synergy similarity between stroke and healthy will be calculated using their scalar product.
|
Baseline, six-week, 10-week, and 18-week follow-ups.
|
|
Pairwise joint angle-to-angle correlation value
Prazo: Baseline, six- week, 10-week, and 18-week follow-ups.
|
Pairwise joint angle-to-angle correlation is a way to see the joint coupling using kinematic data.
It will be calculated using Pearson's correlation coefficient between joint angles during the point-to-point reaching task.
|
Baseline, six- week, 10-week, and 18-week follow-ups.
|
|
Active range of motion
Prazo: Baseline, six-week, 10-week, and 18-week follow-ups.
|
The active range of motion will be calculated from full active range tasks for shoulder flexion/extension, internal/external rotation, abduction/adduction, elbow flexion/extension, and wrist pronation/supination. Kinematic joint positions and angles will be used to calculate the same.
|
Baseline, six-week, 10-week, and 18-week follow-ups.
|
|
EEG Spectral power ratios
Prazo: Baseline and six-week follow-up.
|
EEG-derived spectral power ratios will be calculated, in resting and task conditions, across different frequency bands (delta, theta, alpha, beta, gamma) and different events (onset, successful match, etc.) across four different directions of target match.
|
Baseline and six-week follow-up.
|
|
EEG-derived Brain Symmetry Index
Prazo: Baseline and six-week follow-up.
|
The revised brain symmetry index with EEG signals will be computed in the resting state during eyes open and closed conditions.
|
Baseline and six-week follow-up.
|
|
Cortico-muscular connectivity
Prazo: Baseline and six-week follow-up.
|
Functional connectivity using a directed transfer function will be computed to identify the information flow and coherence among EEG and EMG signals in the desired brain region and muscle activation associated with directional 4-target isometric force generation.
|
Baseline and six-week follow-up.
|
|
Cortico-cortical connectivity
Prazo: Baseline and six-week follow-up.
|
Functional connectivity using a directed transfer function will be computed to identify the information flow and coherence among EEG signals from different regions of interest (sources, e.g., ipsi and contralesional fronto-parietal regions, primary motor cortex and somatosensory cortices).
|
Baseline and six-week follow-up.
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Participant recruitment rate
Prazo: From participant recruitment beginning to enrollment completion
|
Recruitment rate will be calculated as the number of participants enrolled per month during the recruitment period.
This is a feasibility outcome.
|
From participant recruitment beginning to enrollment completion
|
|
Participant intervention adherence
Prazo: Throughout the 6-week intervention period.
|
Intervention adherence will be calculated as the percentage of scheduled intervention sessions completed by each participant.
This is a feasibility outcome.
|
Throughout the 6-week intervention period.
|
|
Participant Tolerance of the Intervention
Prazo: Throughout the 6-week intervention period.
|
Participant tolerance will be measured as the number and percentage of participants who complete intervention sessions without stopping due to discomfort, fatigue, pain, or other intolerance-related reasons.
This is a feasibility outcome.
|
Throughout the 6-week intervention period.
|
|
Intervention fidelity
Prazo: Throughout the 6-week intervention period.
|
Intervention fidelity will be calculated as the percentage of intervention sessions delivered according to the study protocol.
This is a feasibility outcome.
|
Throughout the 6-week intervention period.
|
|
Dose equivalence between the intervention groups
Prazo: Throughout the 6-week intervention period.
|
Dose equivalence will be assessed by comparing total intervention dose between groups, measured as total minutes of training and/or number of completed sessions per participant.
This is a feasibility outcome.
|
Throughout the 6-week intervention period.
|
|
NICE-specific training feasibility
Prazo: Throughout the 6-week intervention period.
|
NICE-specific feasibility will be assessed as the percentage of NICE intervention sessions in which the NICE training system/protocol is successfully implemented as intended.
This is a feasibility outcome.
|
Throughout the 6-week intervention period.
|
|
Participant retention rate
Prazo: Baseline, six-week, 10-week, and 18- week follow-ups and throughout the 6-week intervention period.
|
Retention rate will be calculated as the percentage of enrolled participants who complete each scheduled follow-up assessment.
This is a feasibility outcome.
|
Baseline, six-week, 10-week, and 18- week follow-ups and throughout the 6-week intervention period.
|
|
Successful acquisition of study data
Prazo: Baseline, six-week, 10-week, and 18- week follow-ups and throughout the 6-week intervention period.
|
Successful data acquisition will be calculated as the percentage of expected EMG, EEG, kinematic, and clinical outcome datasets successfully collected and usable for analysis.
This is a feasibility outcome.
|
Baseline, six-week, 10-week, and 18- week follow-ups and throughout the 6-week intervention period.
|
|
Box and Block Test (BBT) score
Prazo: Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
|
The gross manual dexterity and upper extremity coordination will be assessed through BBT, which involves transfer of blocks from one compartment of a box to the other within 60 seconds.
The score is the number of blocks successfully transferred to the other side within 60 seconds.
|
Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
|
|
Modified Ashworth Scale (MAS) score
Prazo: Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
|
The increase in muscle tone will be assessed through MAS around the elbow and shoulder.
MAS score ranges from 0 to 5. The MAS score reflects the severity of muscle spasticity.
|
Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
|
|
Wolf Motor Function Test (WMFT) score
Prazo: Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
|
Motor function will be assessed through WMFT, which evaluates both the time and quality of performance across 17 tasks that range from simple joint movements to complex functional activities (like lifting a can or folding a towel).
Performance Time (sec) is measured, with a maximum time limit (usually 120 seconds).
Functional Ability Scale rates the quality of movement, using a 6-point ordinal scale (0 = Does not attempt with the involved arm, 1 = Attempted but cannot complete task, 2 = Completes task with great difficulty or poor movement quality, 3 = Completes task with moderate difficulty or noticeable impairment, 4 = Completes task with minor difficulty or near-normal movement, 5 = Normal movement quality and speed).
The WMFT score assesses upper extremity motor function.
|
Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Jinsook Roh, PhD, University of Houston
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Roh J, Cheung VC, Bizzi E. Modules in the brain stem and spinal cord underlying motor behaviors. J Neurophysiol. 2011 Sep;106(3):1363-78. doi: 10.1152/jn.00842.2010. Epub 2011 Jun 8.
- Dewald JP, Sheshadri V, Dawson ML, Beer RF. Upper-limb discoordination in hemiparetic stroke: implications for neurorehabilitation. Top Stroke Rehabil. 2001 Spring;8(1):1-12. doi: 10.1310/WA7K-NGDF-NHKK-JAGD.
- Nordin AD, Hairston WD, Ferris DP. Faster Gait Speeds Reduce Alpha and Beta EEG Spectral Power From Human Sensorimotor Cortex. IEEE Trans Biomed Eng. 2020 Mar;67(3):842-853. doi: 10.1109/TBME.2019.2921766. Epub 2019 Jun 13.
- Roh J, Beer RF, Lai A, Rho M, Karvelas KR, Nader AM, Kendall MC, Rymer WZ. The Effects of Selective Muscle Weakness on Muscle Coordination in the Human Arm. Appl Bionics Biomech. 2018 Sep 19;2018:5637568. doi: 10.1155/2018/5637568. eCollection 2018.
- Park JH, Lee H, Kwon HJ, Shin JH, Roh J, Park HS. Feasibility of Isokinetic Training to Modify Coupling of Upper Limb Muscle Synergy Activation in Stroke-affected Upper Limb. Annu Int Conf IEEE Eng Med Biol Soc. 2023 Jul;2023:1-4. doi: 10.1109/EMBC40787.2023.10339985.
- Portilla-Jimenez M, Seo G, Houston M, Hong YNG, Li S, Park HS, Zhang Y, Roh J. Improving impaired intermuscular coordination after stroke through synergy-guided human-machine interaction: a pilot study. Annu Int Conf IEEE Eng Med Biol Soc. 2024 Jul;2024:1-4. doi: 10.1109/EMBC53108.2024.10782001.
- Seo G, Park JH, Park HS, Roh J. Developing new intermuscular coordination patterns through an electromyographic signal-guided training in the upper extremity. J Neuroeng Rehabil. 2023 Sep 1;20(1):112. doi: 10.1186/s12984-023-01236-2.
- Seo G, Kishta A, Mugler E, Slutzky MW, Roh J. Myoelectric interface training enables targeted reduction in abnormal muscle co-activation. J Neuroeng Rehabil. 2022 Jul 1;19(1):67. doi: 10.1186/s12984-022-01045-z.
- Li S. Stroke Recovery Is a Journey: Prediction and Potentials of Motor Recovery after a Stroke from a Practical Perspective. Life (Basel). 2023 Oct 15;13(10):2061. doi: 10.3390/life13102061.
Links úteis
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 (Estimado)
1 de agosto de 2027
Conclusão Primária (Estimado)
1 de agosto de 2032
Conclusão do estudo (Estimado)
1 de agosto de 2032
Datas de inscrição no estudo
Enviado pela primeira vez
22 de outubro de 2025
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de abril de 2026
Primeira postagem (Real)
15 de abril de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00001333-NICE
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .