Improving Independent Multi-joint Arm Control After Stroke (NICE)

University of Houston

Status: Enrolling

Conditions: Stroke

Treatments: Other: Neuromuscular coordination-guided rehabilitative training; Other: Force strengthening-guided rehabilitative training

Study type: Interventional

Funder types: Other

Identifiers

NCT06523335

STUDY00001333

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Neuromuscular coordination-guided rehabilitative training

Experimental group

Description:

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.

Treatment:

Other: Neuromuscular coordination-guided rehabilitative training

Force strengthening-guided rehabilitative training

Active Comparator group

Description:

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.

Treatment:

Other: Force strengthening-guided rehabilitative training