Rehabilitación de Mejora de la Coordinación Neuro-Inter-Muscular (NICE) Guiada por EMG a través de la Interacción Humano-Máquina (NICE)
15 de junio de 2026 actualizado por: Jinsook Roh, University of Houston
Rehabilitación de Mejora de la Coordinación Neuro-Muscular (NICE)
El objetivo de este estudio es desarrollar la rehabilitación de Mejora de la Coordinación Neuro-Muscular (NICE), una estrategia novedosa guiada por señales de control neuromuscular que guía visualmente a pacientes con ictus para activar individualmente grupos de músculos sinérgicos mediante la interacción humano-máquina.
En última instancia, el desarrollo conducirá a una mejor recuperación motora clínica, una mejor calidad de vida y una reducción de los costes sanitarios asociados a la discapacidad.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
El ictus es la principal causa de discapacidad grave a largo plazo, que afecta a 9,4 millones de estadounidenses. Cada año, alrededor de 800.000 personas sufren un ictus incluso en Estados Unidos. La discapacidad motora crónica de la extremidad superior es un factor importante que contribuye a la discapacidad; el uso funcional de la extremidad superior afectada en la vida diaria es un factor clave para aumentar la independencia, la vuelta al trabajo y la calidad de vida en general. Por lo tanto, un tratamiento eficaz e innovador para abordar la discapacidad a largo plazo es tanto una necesidad importante de salud pública como una necesidad económica.
El estudio desarrollará una plataforma innovadora de interacción humano-máquina para dirigir y mejorar la coordinación entre articulaciones y la función motora mediante la mejora de la coordinación muscular en la extremidad superior. En este estudio, en total, 38 supervivientes de ictus crónico serán asignados aleatoriamente a dos estrategias de rehabilitación: ejercicio guiado por coordinación neuromuscular (NICE; grupo de terapia) o ejercicio guiado por fuerza (grupo de control). Los criterios de inclusión consisten principalmente en: (1) haber experimentado un ictus isquémico o hemorrágico al menos 6 meses antes (ictus crónico); (2) tener entre 21 y 80 años de edad; (3) no haber recibido tratamiento con toxina botulínica en el brazo afectado en los últimos 3 meses; y (4) no tener deterioros cognitivos que afecten la comprensión de las tareas o la capacidad de dar consentimiento informado.
Este estudio evaluará los efectos de ambos ejercicios de rehabilitación en la coordinación muscular, las puntuaciones clínicas estandarizadas, la cinética y el electroencefalograma.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
48
Fase
- Fase temprana 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Jinsook Roh, PhD
- Número de teléfono: 7137432578
- Correo electrónico: jroh@Central.UH.EDU
Ubicaciones de estudio
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Texas
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Houston, Texas, Estados Unidos, 77045
- University of Houston
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Contacto:
- JIN-SOOK ROH, PhD
- Número de teléfono: 6173680050
- Correo electrónico: jsroh@central.uh.edu
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Investigador principal:
- Jinsook Roh, PhD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Criterios de inclusión:
- Accidente cerebrovascular isquémico o hemorrágico
- Edad comprendida entre 21 y 80 años
- No haber recibido toxina botulínica en el brazo afectado en los últimos 3 meses
- MAS ≤ 3 alrededor del codo y el hombro
Criterios de exclusión:
- Tener un trastorno ortopédico que afecte a las extremidades superiores;
- Deterioro cognitivo suficiente para interferir con el consentimiento informado o la finalización exitosa del protocolo (puntuación en la Evaluación Cognitiva de Montreal (MoCA) ≤ 26);
- Antecedentes de otra enfermedad neurológica;
- Anestesia del sentido de posición articular en las extremidades superiores;
- Estar embarazada o tener posibilidad de estarlo (autodeclarado);
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
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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. |
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Comparador activo: 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.
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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).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Fugl-Meyer Assessment (FMA) score
Periodo de tiempo: Baseline, six- week, 10-week, and 18-week follow-ups.
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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.
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Baseline, six- week, 10-week, and 18-week follow-ups.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Similarity Score of Intermuscular Coordination Patterns (or Motor Modules)
Periodo de tiempo: Baseline, six- week, 10-week, and 18-week follow-ups.
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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.
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Baseline, six- week, 10-week, and 18-week follow-ups.
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Kinematic Synergy Similarity Score
Periodo de tiempo: Baseline, six-week, 10-week, and 18-week follow-ups.
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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.
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Baseline, six-week, 10-week, and 18-week follow-ups.
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Pairwise joint angle-to-angle correlation value
Periodo de tiempo: Baseline, six- week, 10-week, and 18-week follow-ups.
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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.
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Baseline, six- week, 10-week, and 18-week follow-ups.
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Active range of motion
Periodo de tiempo: Baseline, six-week, 10-week, and 18-week follow-ups.
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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.
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Baseline, six-week, 10-week, and 18-week follow-ups.
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EEG Spectral power ratios
Periodo de tiempo: Baseline and six-week follow-up.
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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.
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Baseline and six-week follow-up.
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EEG-derived Brain Symmetry Index
Periodo de tiempo: Baseline and six-week follow-up.
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The revised brain symmetry index with EEG signals will be computed in the resting state during eyes open and closed conditions.
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Baseline and six-week follow-up.
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Cortico-muscular connectivity
Periodo de tiempo: Baseline and six-week follow-up.
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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.
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Baseline and six-week follow-up.
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Cortico-cortical connectivity
Periodo de tiempo: Baseline and six-week follow-up.
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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).
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Baseline and six-week follow-up.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Participant recruitment rate
Periodo de tiempo: From participant recruitment beginning to enrollment completion
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Recruitment rate will be calculated as the number of participants enrolled per month during the recruitment period.
This is a feasibility outcome.
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From participant recruitment beginning to enrollment completion
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Participant intervention adherence
Periodo de tiempo: Throughout the 6-week intervention period.
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Intervention adherence will be calculated as the percentage of scheduled intervention sessions completed by each participant.
This is a feasibility outcome.
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Throughout the 6-week intervention period.
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Participant Tolerance of the Intervention
Periodo de tiempo: Throughout the 6-week intervention period.
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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.
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Throughout the 6-week intervention period.
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Intervention fidelity
Periodo de tiempo: Throughout the 6-week intervention period.
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Intervention fidelity will be calculated as the percentage of intervention sessions delivered according to the study protocol.
This is a feasibility outcome.
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Throughout the 6-week intervention period.
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Dose equivalence between the intervention groups
Periodo de tiempo: Throughout the 6-week intervention period.
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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.
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Throughout the 6-week intervention period.
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NICE-specific training feasibility
Periodo de tiempo: Throughout the 6-week intervention period.
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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.
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Throughout the 6-week intervention period.
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Participant retention rate
Periodo de tiempo: Baseline, six-week, 10-week, and 18- week follow-ups and throughout the 6-week intervention period.
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Retention rate will be calculated as the percentage of enrolled participants who complete each scheduled follow-up assessment.
This is a feasibility outcome.
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Baseline, six-week, 10-week, and 18- week follow-ups and throughout the 6-week intervention period.
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Successful acquisition of study data
Periodo de tiempo: Baseline, six-week, 10-week, and 18- week follow-ups and throughout the 6-week intervention period.
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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.
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Baseline, six-week, 10-week, and 18- week follow-ups and throughout the 6-week intervention period.
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Box and Block Test (BBT) score
Periodo de tiempo: Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
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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.
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Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
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Modified Ashworth Scale (MAS) score
Periodo de tiempo: Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
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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.
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Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
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Wolf Motor Function Test (WMFT) score
Periodo de tiempo: Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
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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.
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Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jinsook Roh, PhD, University of Houston
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2027
Finalización primaria (Estimado)
1 de agosto de 2032
Finalización del estudio (Estimado)
1 de agosto de 2032
Fechas de registro del estudio
Enviado por primera vez
22 de octubre de 2025
Primero enviado que cumplió con los criterios de control de calidad
8 de abril de 2026
Publicado por primera vez (Actual)
15 de abril de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
15 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00001333-NICE
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .