About this trial
The objective of this study is to develop Neuro-Intermuscular Coordination Enhancement (NICE) rehabilitation, a novel neuromuscular control signal-guided strategy that visually guides stroke patients to individually activate motor modules through human-machine interaction. Ultimately, the development will lead to better clinical motor recovery, better quality of life, and lowered healthcare costs associated with the impairment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Hemiparetic chronic stroke survivors more than 6 months after stroke onset
Adults aged 21-80 years, including both female and male participants
Individuals with a single unilateral ischemic or hemorrhagic stroke
Individuals with Upper Extremity Fugl-Meyer Assessment score between 10 and 59 out of 66
Disqualifiers
Individuals younger than 21 years of age or older than 80 years of age
Individuals with an orthopedic disorder involving the upper limbs
Individuals unable to produce voluntary upper-extremity muscle EMG activity;
Individuals with cognitive impairment sufficient to interfere with informed consent or successful completion of the protocol, assessed using the Montreal Cognitive Assessment or other IRB-approved screening procedures.
Trial design
Parallel
Treatments tested in this trial
Neuromuscular coordination enhancement (NICE) intervention
Other interventionNeuro-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.
EMG Amplitude Biofeedback Exercise
Other interventionEMG 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).
Treatment groups
Trial outcomes
Primary outcomes
Fugl-Meyer Assessment (FMA) score
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.
Secondary outcomes
Similarity Score of Intermuscular Coordination Patterns (or Motor Modules)
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.
Kinematic Synergy Similarity Score
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.
Pairwise joint angle-to-angle correlation value
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.
Active range of motion
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.
Other outcomes
Participant recruitment rate
Recruitment rate will be calculated as the number of participants enrolled per month during the recruitment period. This is a feasibility outcome.
Participant intervention adherence
Intervention adherence will be calculated as the percentage of scheduled intervention sessions completed by each participant. This is a feasibility outcome.
Participant Tolerance of the Intervention
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.
Intervention fidelity
Intervention fidelity will be calculated as the percentage of intervention sessions delivered according to the study protocol. This is a feasibility outcome.
Sponsors and contacts
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University of Houston
Lead sponsor
TIRR Memorial Hermann
Collaborator
The University of Texas Health Science Center, Houston
Collaborator
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