Improving Independent Multi-joint Arm Control After Stroke

NCT ID: NCT06523335

Last Updated: 2024-07-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2029-09-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Neuromuscular coordination-guided rehabilitative training

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Force strengthening-guided rehabilitative training

Intervention Type: 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.

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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;
• 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

• 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;
• 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);

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UT Health Houston

UNKNOWN

Sponsor Role: collaborator

Korea Advanced Institute of Science and Technology

OTHER

Sponsor Role: collaborator

University of Houston

OTHER

Sponsor Role: lead

Responsible Party

Jinsook Roh

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinsook Roh, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Houston

Locations

University of Houston

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jinsook Roh, PhD

Role: CONTACT

jroh@Central.UH.EDU

7137432578

Manuel A Portilla-Jiménez, MS, BME

Role: CONTACT

maportillajimenez@uh.edu

3467194921

Facility Contacts

Jinsook Roh, PhD

Role: primary

jroh@central.uh.edu

713-743-2578

Manuel A Portilla-Jiménez, MS, BME

Role: backup

maportillajimenez@uh.edu

346-719-4921

References

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.

Reference Type: BACKGROUND

PMID: 16407573 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3804600 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7735890 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22279190 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23155178 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32000790 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24376069 (View on PubMed)

Related Links

https://www.reignlaboratory.com/projects-3

Laboratory Webpage

Other Identifiers

STUDY00001333

Identifier Type: -

Identifier Source: org_study_id