Recruiting

Observational Study

Sponsor:

University of Houston

Code:

NCT06523335

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

Neuromuscular coordination-guided rehabilitative training

Force strengthening-guided rehabilitative training

Study Details

Brief 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 upper extremity muscles after stroke.

Conditions

Stroke

Study ID

NCT06523335

Start date

Oct 1, 2024

Status verified date

Apr, 2026

Completion date

Sep 1, 2029

Anticipated

Primary completion date

Sep 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

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);

Study Design

Enrollment

74 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Manuel A Portilla-Jiménez, MS, BME

3467194921maportillajimenez@uh.edu

Locations

University of Houston

Recruiting

Houston, Texas, United States, 77204

Contacts

Manuel A Portilla-Jiménez, MS, BME

346-719-4921maportillajimenez@uh.edu

More Information

Sponsor

University of Houston

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by University of Houston on 2026-05-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.