EMG-guided Neuro-Intermuscular Coordination Enhancement (NICE) Rehabilitation Through Human-Machine Interaction

Early Phase 1RecruitingNCT07531264

University of Houston48 enrolled

Overview

The objective of this study is to develop Neuro-Intermuscular Coordination Enhancement (NICE) rehabilitation, a novel neuromuscular control signal-guided strategy that visually guides stroke patients to individually activate groups of synergistic muscles through human-machine interaction. Ultimately, the development will lead to better clinical motor recovery, better quality of life, and lowered healthcare costs associated with the impairment.

Stroke is the leading cause of severe long-term disability, affecting 9.4 million Americans. Each year around 800,000 people suffer a stroke even in the USA. Chronic upper extremity motor impairment is a major contributing factor to disability; functional use of the affected UE in daily life is a key factor for increased independence, return to work, and overall quality of life. Thus, effective and innovative treatment to address long-term disability is both a major public health need and an economic necessity. The study will develop an innovative human-machine interaction platform to target and improve inter-joint coordination and motor function by enhancing muscular coordination in the UE. This study, in total, 38 chronic stroke survivors will be randomly assigned into two rehabilitation strategies either neuromuscular-coordination guided exercise (NICE; therapy group) or force-guided exercise (control group). The inclusion criteria primarily consist of: (1) having experienced an ischemic or hemorrhagic stroke at least 6 months prior (chronic stroke); (2) being between 21 and 80 years of age; (3) not having received botulinum toxin treatment in the affected arm within the past 3 months; and (4) having no cognitive impairments that would affect task comprehension or the ability to provide informed consent. This study will evaluate the effects of both rehabilitation exercises on muscle coordination, standardized clinical scores, kinetics, and electroencephalogram.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Interventions

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Ischemic or hemorrhagic stroke * Aged between 21 and 80 years * Not receiving botulinum toxin on the impaired arm within 3 months * MAS ≤ 3 around elbow and shoulder Exclusion Criteria: * 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);

Outcomes

Primary Outcomes

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).

Time frame: Pre-Training (baseline), post-training (6-week follow-up), 10-week and 18-week follow ups

Change in similarity score of intermuscular coordination patterns

EMGs will be recorded from 8 muscles. To assess whether muscle-synergy guided and/or force-guided exercise induce changes in the composition of intermuscular coordination patterns (ICoPs), non-negative matrix factorization will be applied to EMGs to identify and compare ICoPs.

Time frame: Pre-Training (baseline), post-training (6-week follow-up), 10-week and 18-week follow ups

Secondary Outcomes

Change in kinematic synergy

Kinematic synergies are a representation of multi-joint coordination. It will be identified using NNMF applied to the joint kinematic data obtained from 3D dynamic point-to-point reaching and drinking tasks.