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NCT Number: NCT06523335

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

The purposes of this study include:

1. - To identify whether features of aberrant intermuscular coordination patterns can be used to predict motor impairment after stroke. 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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Stroke is a leading cause of long-term disability in the United States. Of the more than 700,000 Americans who experience a stroke each year, two-thirds survive. 69% of patients who were admitted to a rehabilitation unit following stroke have mild to severe upper extremity dysfunction. Currently, there are more than seven million stroke survivors in the U.S., many of whom have long-term motor and sensory impairments, especially in the arm. The objective of this study involves both scientific and clinical aspects:

For the first purpose, intermuscular coordination patterns emerging under isometric reaching and dynamic conditions will be identified to predict impairment of both non-motion or motion-involved task performance and severity of motor impairment after stroke. This aim will enroll 15 age-matched (age of 40-75 yo) healthy adults and 25 adult (age of 40-75 yo) stroke survivors. Each stroke participant will have two visit sessions while age-matched will have a single measurement session.

For the second purpose, in total, 74 stroke survivors will perform an electromyographic signal-guided exercise through human-machine interaction to ameliorate motor impairment post-stroke by normalizing abnormal intermuscular coordination patterns in the arm after stroke, and improve motor impairment; also, assessment of the intermuscular coordination, UE Fugl-Meyer (FM), and Action Research Arm Test (ARAT) will be performed. Participants will have three visits per week for six weeks for training sessions. Finally, to test retention of the intervention effect, they will perform two assessment sessions one and three months after finishing the training.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for aged matched healthy group

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

Exclusion criteria

for aged matched healthy group

  • 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.

Inclusion criteria

for stroke group

  • 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.

Exclusion criteria

for stroke group

  • 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);

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Fugl-Meyer Assessment (FMA) score

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

    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).

  2. Change in Action Research Arm Test (ARAT) score

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

    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).

  3. Change in intermuscular coordination patterns

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

    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.

Secondary outcomes

  1. Brain imaging data recording

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

    A non-invasive electroencephalography (EEG) measurement setup will be employed to collect the EEG signal, specifically, thirty-two EEG electrodes will be placed on the scalp, and EEG signals will be measured during an isometric assessment. From EEG, cortico-muscular connectivity, cortico-cortical connectivity, and spectral power features will be extracted.

Study contacts

Contact information is provided by the study sponsor or research team.

Jinsook Roh, PhD

CONTACT

[email protected]

7137432578

Manuel A Portilla-Jiménez, MS, BME

CONTACT

[email protected]

3467194921

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Collaborators

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

Registry information

Official study title

Intermuscular Coordination as a Novel Clinical Target for Stroke Neurorehabilitation

Acronym: NICE

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jul 26, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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