StrokeNICENCT06523335
Increasing the Repertoire of Intermuscular Co-ordination Post Stroke Through EMG-Guided Human-Machine Interaction
A study testing Neuromuscular coordination-guided rehabilitative training and Force strengthening-guided rehabilitative training in people with Stroke, run by University of Houston at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Neuromuscular coordination-guided rehabilitative training and Force strengthening-guided rehabilitative training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female whose age range between 40 and 75
- no known neurological injuries
- 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;
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- 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.
Who cannot join
- 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.
- have an orthopedic disorder involving upper limbs;
Show all 10Show fewer
- 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);
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Houston
Houston, Texas, 77204
Jinsook Roh, PhD, 713-743-2578, jroh@central.uh.edu
Manuel A Portilla-Jiménez, MS, BME, 346-719-4921, maportillajimenez@uh.edu
About this study
Official title: Intermuscular Coordination as a Novel Clinical Target for Stroke Neurorehabilitation
The purposes of this study include:
- - To identify whether features of aberrant intermuscular coordination patterns can be used to predict motor impairment after stroke.
- - 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.
Read the detailed description
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.
- Conditions
- Stroke
- Being tested
- Neuromuscular coordination-guided rehabilitative training, Force strengthening-guided rehabilitative training
- Keywords
- Muscle synergy, Intermuscular Coordination, Electromyogram-guided exercise, Motor neurorehabilitation, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular coordination-guided rehabilitative trainingOther
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 trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Force strengthening-guided rehabilitative training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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
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.
Measured: before any training, after the 6 weeks of training, respectively, and 1 and 3 months after the last training session, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Oct 2024
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Advanced Institute of Science and Technology, The University of Texas Health Science Center, Houston
- Responsible party
- Principal investigator, Jinsook Roh, University of Houston
- Investigators
- Jinsook Roh, PhD, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523335
- Sponsor's protocol ID
- STUDY00001333
- Acronym
- NICE
- Status last verified
- Apr 2026
- First submitted
- 22 Jul 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16407573Parker 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.
PubMed 3804600Dewald 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.
PubMed 7735890Roh 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.
PubMed 22279190Roh 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.
PubMed 23155178Carpinella 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.
PubMed 32000790Wright 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.
PubMed 24376069
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermuscular Coordination as a Novel Clinical Target for Stroke Neurorehabilitation
- ClinicalTrials.gov ID
- NCT06523335
- Acronym / sponsor ID
- NICE / STUDY00001333
- Conditions
- Stroke
- Keywords
- Muscle synergy, Intermuscular Coordination, Electromyogram-guided exercise, Motor neurorehabilitation, Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- Korea Advanced Institute of Science and Technology, The University of Texas Health Science Center, Houston
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study include:
- - To identify whether features of aberrant intermuscular coordination patterns can be used to predict motor impairment after stroke.
- - 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular coordination-guided rehabilitative training | Experimental | Other: Neuromuscular coordination-guided rehabilitative trainingPost-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. |
| Force strengthening-guided rehabilitative training | Active comparator | Other: Force strengthening-guided rehabilitative trainingPost-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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female whose age range between 40 and 75
- no known neurological injuries
- male or female hemiparetic chronic stroke survivors;
- age ranging between 40-75 year;
- with single unilateral ischemic or hemorrhagic middle cerebral artery stroke;
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular coordination-guided rehabilitative trainingDuring 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. | Other | Neuromuscular coordination-guided rehabilitative training |
| Force strengthening-guided rehabilitative trainingDuring 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. | Other | Force strengthening-guided rehabilitative training |
Primary outcome
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).
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).
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 16407573Thom 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.
- Background: PubMed 3804600Parker 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.
- Background: PubMed 7735890Dewald 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.
- Background: PubMed 22279190Roh 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.
- Background: PubMed 23155178Roh 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.
- Background: PubMed 32000790Carpinella 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.
- Background: PubMed 24376069Wright 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.
- Laboratory WebpageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jinsook Roh, PhD principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular coordination-guided rehabilitative training and Force strengthening-guided rehabilitative training in people with Stroke, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinsook Roh, PhD (7137432578, jroh@Central.UH.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06523335, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.