Neuro-Intermuscular Coordination Enhancement (NICE) Rehabilitation
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in Fugl-Meyer Assessment (FMA) score
研究概览
简要总结
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 motor modules 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.
详细描述
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.
This study is an early-stage, randomized controlled rehabilitation trial designed to evaluate the clinical effects, feasibility, transfer of therapeutic gains, and exploratory neurophysiological correlates of Neuro-Intermuscular Coordination Enhancement (NICE) in individuals with chronic stroke and upper-extremity hemiparesis.
Forty-eight participants will be enrolled to obtain a target analyzable sample of 40 participants. Eligible participants will be randomized to either: (1) NICE, a motor module-guided rehabilitation intervention using isometric human-machine interaction and real-time EMG-based visual feedback to retrain impaired intermuscular coordination patterns; or (2) an active comparator consisting of dose-matched EMG amplitude biofeedback exercise. Both interventions will be delivered three times per week for six weeks (18 total sessions). Participants will complete assessments at baseline, immediately post-intervention, and at 10- and 18-week follow-up time points.
Outcomes will include standardized clinical measures of upper-extremity motor impairment and function, measures of intermuscular coordination derived from surface electromyography, kinematic measures obtained during untrained dynamic motor tasks, and EEG-based measures of brain activity and connectivity.
The primary objective is to determine whether NICE improves upper-extremity motor impairment relative to the active comparator. Secondary objectives are to evaluate intervention-related changes in intermuscular coordination and transfer of therapeutic gains to untrained motor behaviors. Exploratory objectives are to characterize rehabilitation-associated neurophysiological changes and examine relationships among EEG-derived biomarkers, intermuscular coordination, and clinical recovery outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for individuals after stroke are:
- •Hemiparetic chronic stroke survivors more than 6 months after stroke onset
- •Adults aged 21-80 years, including both female and male participants
- •Individuals with a single unilateral ischemic or hemorrhagic stroke
- •Individuals with Upper Extremity Fugl-Meyer Assessment score between 10 and 59 out of 66
- •Individuals who have not received botulinum toxin injections in the upper extremity within the past 3 months
- •Individuals without severe spasticity, defined as Modified Ashworth Scale score ≤3 at the elbow and shoulder
排除标准
- •for individuals after stroke are:
- •Individuals younger than 21 years of age or older than 80 years of age
- •Individuals with an orthopedic disorder involving the upper limbs
- •Individuals unable to produce voluntary upper-extremity muscle EMG activity;
- •Individuals with cognitive impairment sufficient to interfere with informed consent or successful completion of the protocol, assessed using the Montreal Cognitive Assessment or other IRB-approved screening procedures.
- •Individuals whose stroke-affected arm has an intermuscular coordination pattern similarity score >0.80 relative to the non-affected arm
- •Inclusion criteria for healthy individuals are:
- •Healthy adults aged 21-80 years, including both female and male participants
- •Individuals with no known neurological or orthopedic injuries
- •Exclusion criteria for healthy individuals are:
- •Individuals younger than 21 years of age or older than 80 years of age
- •Individuals with known neurological disorders
- •Individuals with orthopedic injuries or conditions affecting upper-extremity movement
- •Individuals unable to provide informed consent
结局指标
主要结局
Change in Fugl-Meyer Assessment (FMA) score
时间窗: Pre-Training (baseline), post-training (6-week follow-up), 10-week and 18-week follow ups
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).
Change in similarity score of intermuscular coordination patterns
时间窗: Pre-Training (baseline), post-training (6-week follow-up), 10-week and 18-week follow ups
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.
次要结局
- Change in kinematic synergy(Pre-Training (baseline), post-training (6-week follow-up))
- Change in pairwise joint angle-to-angle correlation(Pre-Training (baseline), post-training (6-week follow-up))
- Change in similarity score of intermuscular coordination patterns in dynamic task(Pre-Training (baseline), post-training (6-week follow-up))
- Change in active range of motion(Pre-Training (baseline), post-training (6-week follow-up))
- Changes in EEG-derived spectral powers(Pre-Training (baseline), post-training (6-week follow-up))
- Change in Revised Brain Symmetry Index(Pre-Training (baseline), post-training (6-week follow-up))
- Change in cortico-muscular connectivity(Pre-Training (baseline), post-training (6-week follow-up))
- Change in cortico-cortical connectivity(Pre-Training (baseline), post-training (6-week follow-up))
研究者
Jinsook Roh
Associate Professor
University of Houston