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

Official title

Intermuscular Coordination as a Novel Clinical Target for Stroke Neurorehabilitation

Overview

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.

Interventions

• Other 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.
• 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.

Primary outcome measures

• 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]

Secondary outcome measures (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]

Eligibility 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);

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Houston — Houston

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 s PMID 16407573
• 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. PMID 3804600
• 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. PMID 7735890
• 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. PMID 22279190
• 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. PMID 23155178
• 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. PMID 32000790
• 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. PMID 24376069

Identifiers

NCT: NCT06523335 · STUDY00001333

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗