Increasing the Repertoire of Intermuscular Co-ordination Post Stroke Through EMG-Guided Human-Machine Interaction

NCT06523335 | Recruiting

• 1 other identifier: STUDY00001333
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study include:

1. 1.\- To identify whether features of aberrant intermuscular coordination patterns can be used to predict motor impairment after stroke.
2. 2.\- To test whether muscle synergies are malleable to a non-invasive EMG-guided exercise that induces changes in intermuscular coordination of upper extremity muscles after stroke.

Conditions

Stroke

Keywords

Muscle synergy; Intermuscular Coordination; Electromyogram-guided exercise; Motor neurorehabilitation; Stroke

Outcome Measures

Primary Outcomes (3)

• 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).

  before any training, after the 6 weeks of training, respectively, and 1 and 3 months after the last training session, respectively

• 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).

  before any training, after the 6 weeks of training, respectively, and 1 and 3 months after the last training session, respectively

• Change in intermuscular coordination patterns

  EMGs will be recorded from 12 muscles. To assess whether muscle-synergy guided and/or force-guided exercise induce changes in the composition of intermuscular coordination patterns, non-negative matrix factorization will be applied to EMGs to identify and compare ICoPs. The features from EMG are muscle synergy (motor module) composition and activation profiles.

  before any training, after the 6 weeks of training, respectively, and 1 and 3 months after the last training session, respectively

Secondary Outcomes (1)

• Brain imaging data recording

  before any training, after the 6 weeks of training, respectively, and 1 and 3 months after the last training session, respectively

Study Arms (2)

Neuromuscular coordination-guided rehabilitative training

EXPERIMENTAL

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

Force strengthening-guided rehabilitative training

ACTIVE COMPARATOR

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

Interventions

Neuromuscular coordination-guided rehabilitative training OTHER

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.

Neuromuscular coordination-guided rehabilitative training

Force strengthening-guided rehabilitative training OTHER

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.

Force strengthening-guided rehabilitative training

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female whose age range between 40 and 75
• no known neurological injuries

You may not qualify if:

• have an orthopedic disorder involving upper limbs;
• have a history of any neurologic disease;
• have any history of epilepsy of the potential participants and/or their family members;
• are unable to consent;
• are pregnant.
• male or female hemiparetic chronic stroke survivors;
• age ranging between 40-75 year;
• with single unilateral ischemic or hemorrhagic middle cerebral artery stroke;
• neurologically stable for \>6 months;
• have an expectation that current medication will be maintained without changes for at least 3 months. Stable use of anti-spasticity medication (e.g., baclofen, diazepam, tizanidine) is accepted;
• without severe spasticity (Modified Ashworth (MA) \<4);
• have not received botulinum toxin on the impaired arm within 3 months.
• 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;

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: collaborator
• University of Houston: lead
• Korea Advanced Institute of Science and Technology: collaborator

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

RECRUITING

Related Publications (7)

• Thom T, Haase N, Rosamond W, Howard VJ, Rumsfeld J, Manolio T, Zheng ZJ, Flegal K, O'Donnell C, Kittner S, Lloyd-Jones D, Goff DC Jr, Hong Y, Adams R, Friday G, Furie K, Gorelick P, Kissela B, Marler J, Meigs J, Roger V, Sidney S, Sorlie P, Steinberger J, Wasserthiel-Smoller S, Wilson M, Wolf P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2006 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2006 Feb 14;113(6):e85-151. doi: 10.1161/CIRCULATIONAHA.105.171600. Epub 2006 Jan 11. No abstract available.

  PMID: 16407573 BACKGROUND

• Parker VM, Wade DT, Langton Hewer R. Loss of arm function after stroke: measurement, frequency, and recovery. Int Rehabil Med. 1986;8(2):69-73. doi: 10.3109/03790798609166178.

  PMID: 3804600 BACKGROUND

• Dewald JP, Pope PS, Given JD, Buchanan TS, Rymer WZ. Abnormal muscle coactivation patterns during isometric torque generation at the elbow and shoulder in hemiparetic subjects. Brain. 1995 Apr;118 ( Pt 2):495-510. doi: 10.1093/brain/118.2.495.

  PMID: 7735890 BACKGROUND

• Roh J, Rymer WZ, Beer RF. Robustness of muscle synergies underlying three-dimensional force generation at the hand in healthy humans. J Neurophysiol. 2012 Apr;107(8):2123-42. doi: 10.1152/jn.00173.2011. Epub 2012 Jan 25.

  PMID: 22279190 BACKGROUND

• Roh J, Rymer WZ, Perreault EJ, Yoo SB, Beer RF. Alterations in upper limb muscle synergy structure in chronic stroke survivors. J Neurophysiol. 2013 Feb;109(3):768-81. doi: 10.1152/jn.00670.2012. Epub 2012 Nov 14.

  PMID: 23155178 BACKGROUND

• Carpinella I, Lencioni T, Bowman T, Bertoni R, Turolla A, Ferrarin M, Jonsdottir J. Effects of robot therapy on upper body kinematics and arm function in persons post stroke: a pilot randomized controlled trial. J Neuroeng Rehabil. 2020 Jan 30;17(1):10. doi: 10.1186/s12984-020-0646-1.

  PMID: 32000790 BACKGROUND

• Wright ZA, Rymer WZ, Slutzky MW. Reducing Abnormal Muscle Coactivation After Stroke Using a Myoelectric-Computer Interface: A Pilot Study. Neurorehabil Neural Repair. 2014 Jun;28(5):443-51. doi: 10.1177/1545968313517751. Epub 2013 Dec 27.

  PMID: 24376069 BACKGROUND

Related Links

• Laboratory Webpage

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Jinsook Roh, PhD

  University of Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinsook Roh, PhD

CONTACT

7137432578; jroh@Central.UH.EDU

Manuel A Portilla-Jiménez, MS, BME

CONTACT

3467194921; maportillajimenez@uh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)