Neuro-Intermuscular Coordination Enhancement (NICE) Rehabilitation Through Human-Machine Interaction in Chronic Stroke

NCT07531264 | Not Yet Recruiting Early Phase 1

• 1 other identifier: STUDY00001333-NICE
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Stroke-related Upper-extremity Motor Impairment; Motor Module-guided Rehabilitation Targeting Impaired Intermuscular Coordination and Motor Recovery

Keywords

Muscle Synergy; Non-invasive Rehabilitation; Intermuscular Coordination; Stroke; Motor module

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, six- week, 10-week, and 18-week follow-ups.

Secondary Outcomes (8)

• Similarity Score of Intermuscular Coordination Patterns (or Motor Modules)

  Baseline, six- week, 10-week, and 18-week follow-ups.

• Kinematic Synergy Similarity Score

  Baseline, six-week, 10-week, and 18-week follow-ups.

• Pairwise joint angle-to-angle correlation value

  Baseline, six- week, 10-week, and 18-week follow-ups.

• Active range of motion

  Baseline, six-week, 10-week, and 18-week follow-ups.

• EEG Spectral power ratios

  Baseline and six-week follow-up.

Other Outcomes (11)

• Participant recruitment rate

  From participant recruitment beginning to enrollment completion

• Participant intervention adherence

  Throughout the 6-week intervention period.

• Participant Tolerance of the Intervention

  Throughout the 6-week intervention period.

Study Arms (2)

Neuromuscular coordination enhancement (NICE) intervention

EXPERIMENTAL

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.

Other: Neuromuscular coordination enhancement (NICE) intervention

EMG-amplitude biofeedback exercise

ACTIVE COMPARATOR

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.

Other: EMG Amplitude Biofeedback Exercise

Interventions

Neuromuscular coordination enhancement (NICE) intervention OTHER

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.

Neuromuscular coordination enhancement (NICE) intervention

EMG Amplitude Biofeedback Exercise OTHER

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).

EMG-amplitude biofeedback exercise

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Individuals who have not received botulinum toxin injections in the upper extremity within the past 3 months
• Individuals without severe spasticity, defined as Modified Ashworth Scale score ≤3 at the elbow and shoulder

You may not qualify if:

• 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.
• Individuals whose stroke-affected arm has an intermuscular coordination pattern similarity score \>0.80 relative to the non-affected arm
• Healthy adults aged 21-80 years, including both female and male participants
• Individuals with no known neurological or orthopedic injuries
• Individuals younger than 21 years of age or older than 80 years of age
• Individuals with known neurological disorders
• Individuals with orthopedic injuries or conditions affecting upper-extremity movement
• Individuals unable to provide informed consent

Sponsors & Collaborators

• University of Houston: lead
• TIRR Memorial Hermann: collaborator
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

University of Houston

Houston, Texas, 77045, United States

Location

Related Publications (9)

• 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.

  PMID: 35778757 BACKGROUND

• 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.

  PMID: 37895442 BACKGROUND

• 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.

  PMID: 21653716 BACKGROUND

• 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.

  PMID: 14523747 BACKGROUND

• 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.

  PMID: 31199248 BACKGROUND

• 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.

  PMID: 30402139 BACKGROUND

• 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.

  PMID: 38082751 BACKGROUND

• 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.

  PMID: 40031505 BACKGROUND

• 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.

  PMID: 37658406 BACKGROUND

Related Links

• Laboratory Webpage

MeSH Terms

Conditions

Stroke

Interventions

Methods

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Jinsook Roh, PhD

  University of Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinsook Roh, PhD

CONTACT

7137432578; jroh@Central.UH.EDU

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is an early-stage, randomized controlled rehabilitation trial where behavioral intervention through human-machine interaction will be performed on stroke survivors.

Study Record Dates

• First Submitted: October 22, 2025
• First Posted: April 15, 2026
• Study Start (Estimated): August 1, 2027
• Primary Completion (Estimated): August 1, 2032
• Study Completion (Estimated): August 1, 2032
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)