通过人机交互实现肌电图引导的神经肌肉协调增强（NICE）康复 (NICE)
2026年6月15日 更新者：Jinsook Roh、University of Houston
神经-肌肉协调增强（NICE）康复
本研究的目标是开发神经肌肉协调增强（NICE）康复疗法，这是一种新颖的神经肌肉控制信号引导策略，通过人机交互视觉引导中风患者独立激活协同肌群。
最终，这一发展将带来更好的临床运动功能恢复、更高的生活质量，并降低与损伤相关的医疗成本。
研究概览
地位
尚未招聘
条件
详细说明
中风是导致严重长期残疾的主要原因，影响940万美国人。 即使在美国，每年约有80万人遭受中风。 慢性上肢运动障碍是导致残疾的主要因素；日常生活中受影响上肢的功能性使用是提高独立性、重返工作岗位和整体生活质量的关键因素。 因此，有效且创新的治疗来解决长期残疾既是主要的公共卫生需求，也是经济上的必要。
本研究将开发一个创新的人机交互平台，通过增强上肢的肌肉协调，以针对和改善关节间协调和运动功能。 本研究总共将38名慢性中风幸存者随机分配到两种康复策略之一：神经肌肉协调引导运动（NICE；治疗组）或力量引导运动（对照组）。 纳入标准主要包括：（1）至少6个月前经历过缺血性或出血性中风（慢性中风）；（2）年龄在21至80岁之间；（3）在过去3个月内未在受影响的手臂接受过肉毒杆菌毒素治疗；（4）没有影响任务理解或提供知情同意能力的认知障碍。
本研究将评估两种康复运动对肌肉协调、标准化临床评分、动力学和脑电图的影响。
研究类型
介入性
注册 (估计的)
48
阶段
- 第一阶段早期
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jinsook Roh, PhD
- 电话号码：7137432578
- 邮箱：jroh@Central.UH.EDU
学习地点
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Texas
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Houston、Texas、美国、77045
- University of Houston
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接触：
- JIN-SOOK ROH, PhD
- 电话号码：6173680050
- 邮箱：jsroh@central.uh.edu
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首席研究员：
- Jinsook Roh, PhD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
纳入标准：
- 缺血性或出血性卒中
- 年龄在21至80岁之间
- 受损手臂在3个月内未接受肉毒毒素治疗
- 肘部和肩部MAS评分≤3
排除标准：
- 患有涉及上肢的骨科疾病；
- 认知障碍足以影响知情同意或方案的成功完成（蒙特利尔认知评估（MoCA）评分≤26）；
- 有另一种神经系统疾病史；
- 上肢关节位置觉缺失；
- 怀孕或有可能怀孕（自我报告）；
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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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有源比较器：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Fugl-Meyer Assessment (FMA) score
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Similarity Score of Intermuscular Coordination Patterns (or Motor Modules)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Participant recruitment rate
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jinsook Roh, PhD、University of Houston
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2027年8月1日
初级完成 (估计的)
2032年8月1日
研究完成 (估计的)
2032年8月1日
研究注册日期
首次提交
2025年10月22日
首先提交符合 QC 标准的
2026年4月8日
首次发布 (实际的)
2026年4月15日
研究记录更新
最后更新发布 (实际的)
2026年6月18日
上次提交的符合 QC 标准的更新
2026年6月15日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.