EMG-guided Neuro-Intermuscular Coordination Enhancement (NICE) Rehabilitation Through Human-Machine Interaction (NICE)

Neuro-Intermuscular Coordination Enhancement (NICE) Rehabilitation

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 groups of synergistic muscles 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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Chronic Stroke; Hemiparetic Stroke
• Intervention / Treatment: Other: Neuromuscular coordination-guided rehabilitative training; Other: Force strengthening-guided rehabilitative training

Detailed Description

Stroke is the leading cause of severe long-term disability, affecting 9.4 million Americans. Each year around 800,000 people suffer a stroke even in the USA. Chronic upper extremity motor impairment is a major contributing factor to disability; functional use of the affected UE in daily life is a key factor for increased independence, return to work, and overall quality of life. Thus, effective and innovative treatment to address long-term disability is both a major public health need and an economic necessity.

The study will develop an innovative human-machine interaction platform to target and improve inter-joint coordination and motor function by enhancing muscular coordination in the UE. This study, in total, 38 chronic stroke survivors will be randomly assigned into two rehabilitation strategies either neuromuscular-coordination guided exercise (NICE; therapy group) or force-guided exercise (control group). The inclusion criteria primarily consist of: (1) having experienced an ischemic or hemorrhagic stroke at least 6 months prior (chronic stroke); (2) being between 21 and 80 years of age; (3) not having received botulinum toxin treatment in the affected arm within the past 3 months; and (4) having no cognitive impairments that would affect task comprehension or the ability to provide informed consent.

This study will evaluate the effects of both rehabilitation exercises on muscle coordination, standardized clinical scores, kinetics, and electroencephalogram.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jinsook Roh, PhD; Phone Number: 7137432578; Email: jroh@Central.UH.EDU

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77045
      • Recruiting
      • University of Houston
      • Contact: JIN-SOOK ROH, PhD; Phone Number: 6173680050; Email: jsroh@central.uh.edu
      • Principal Investigator: Jinsook Roh, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Ischemic or hemorrhagic stroke
• Aged between 21 and 80 years
• Not receiving botulinum toxin on the impaired arm within 3 months
• MAS ≤ 3 around elbow and shoulder

Exclusion Criteria:

• have an orthopedic disorder involving upper limbs;
• cognitive impairment sufficient to interfere with informed consent or successful completion of the protocol (Montreal Cognitive Assessment (MoCA) score =< 26);
• a history of another neurologic disease;
• anesthesia of joint position sense in upper limbs;
• are pregnant or have a chance that they might be (self-reported);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neuromuscular coordination-guided rehabilitative training; Post-stroke participants will perform a center-out task by generating isometric contractions of multiple muscles to move the cursor on a screen while electromyographic (EMG) responses 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 EMGs recorded from multiple arm muscles.	Other: Neuromuscular coordination-guided rehabilitative training; During training exercise, post-stroke participants will be asked to match the targets on the screen. The experimental group will match them by activating a specific set of muscle. During assessment trials, a physical therapist or occupational therapist will rate the functional level of arm impairment using FMA and ARAT.
Active Comparator: Force strengthening-guided rehabilitative training; Post-stroke participants will perform a center-out task by generating isometric force to move the cursor on a screen. Participants will generate isometric force, which will move their cursor on the monitor. They will be trained to match one of the four force targets on display. We will derive the cursor position in real time using three forces (Fx, Fy, and Fz) measured at the load cell.	Other: Force strengthening-guided rehabilitative training; During training exercise, post-stroke participants will be asked to match the targets on the screen. The active comparator group will match them by generating isometric force in a desired target direction. During assessment trials, a physical therapist or occupational therapist will rate the functional level of arm impairment using FMA and ARAT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fugl-Meyer Assessment (FMA) score	To measure severity of motor impairment after stroke, FMA will be performed in the human upper extremity. FMA is commonly used to assess severity of motor impairment and motor recovery. The maximum FMA upper extremity 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).	Pre-Training (baseline), post-training (6-week follow-up), 10-week and 18-week follow ups
Change in similarity score of intermuscular coordination patterns	EMGs will be recorded from 8 muscles. To assess whether muscle-synergy guided and/or force-guided exercise induce changes in the composition of intermuscular coordination patterns (ICoPs), non-negative matrix factorization will be applied to EMGs to identify and compare ICoPs.	Pre-Training (baseline), post-training (6-week follow-up), 10-week and 18-week follow ups

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in kinematic synergy	Kinematic synergies are a representation of multi-joint coordination. It will be identified using NNMF applied to the joint kinematic data obtained from 3D dynamic point-to-point reaching and drinking tasks.	Pre-Training (baseline), post-training (6-week follow-up)
Change in pairwise joint angle-to-angle correlation	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.	Pre-Training (baseline), post-training (6-week follow-up)
Change in similarity score of intermuscular coordination patterns in dynamic task	Surface EMGs will be recorded from 8 key arm muscles during a 3D dynamic task and drinking task. Non-negative matrix factorization will be applied to EMGs to identify and compare intermuscular coordination patterns.	Pre-Training (baseline), post-training (6-week follow-up)
Change in 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.	Pre-Training (baseline), post-training (6-week follow-up)
Changes in EEG-derived spectral powers	EEG-derived spectral powers will be calculated, in resting and task conditions, across different frequency bands and different event-related spectral potentials across four different directions of target match.	Pre-Training (baseline), post-training (6-week follow-up)
Change in Revised Brain Symmetry Index	The revised brain symmetry index with EEG signals will be computed in the resting state during eyes open and closed conditions.	Pre-Training (baseline), post-training (6-week follow-up)
Change in cortico-muscular connectivity	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 (SE, SF, EE, EF) force generation.	Pre-Training (baseline), post-training (6-week follow-up)
Change in cortico-cortical connectivity	Functional connectivity using a directed transfer function will be computed to identify the information flow and coherenceamong EEG signals from different regions of interest (sources, e.g., ipsi and contralesional fronto-parietal regions, primary motor cortex and somatosensory cortices).	Pre-Training (baseline), post-training (6-week follow-up)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Action Research Arm Test (ARAT) score	To measure motor function after stroke, ARAT will be performed in the human upper extremity. 19 Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch, and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally).	Pre-Training (baseline), post-training (6-week follow-up)
Change in Modified Ashworth Scale (MAS)	The increase in muscle tone will be assessed through MAS around the elbow and shoulder. MAS score ranges from 0 to 5.	Pre-Training (baseline), post-training (6-week follow-up)

Collaborators and Investigators

• Sponsor: University of Houston
• Collaborators: The University of Texas Health Science Center, Houston; TIRR Memorial Hermann
• Investigators: Principal Investigator: Jinsook Roh, PhD, University of Houston

Publications and helpful links

General Publications

• Seo G,Kishta A,Mugler E,Slutzky MW,Roh J
• Li S
• 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.

Helpful Links

• Laboratory Webpage

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: October 22, 2025
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Intermuscular Coordination; Electromyogram-guided exercise; Muscle Synergy; Non-invasive Rehabilitation
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: STUDY00001333-NICE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No