Intermuscular Coordination as a Novel Clinical Target for Stroke Neurorehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Change in Fugl-Meyer Assessment (FMA) score
研究概览
简要总结
The purposes of this study include:
- - To identify whether features of aberrant intermuscular coordination patterns can be used to predict motor impairment after stroke.
- - 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.
详细描述
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.
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
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for aged matched healthy group
- •Male or female whose age range between 40 and 75
- •no known neurological injuries
排除标准
- •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);
研究组 & 干预措施
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.
干预措施: Neuromuscular coordination-guided rehabilitative training (Other)
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.
干预措施: Force strengthening-guided rehabilitative training (Other)
结局指标
主要结局
Change in Fugl-Meyer Assessment (FMA) score
时间窗: before any training, after the 6 weeks of training, respectively, and 1 and 3 months after the last training session, respectively
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 Action Research Arm Test (ARAT) score
时间窗: before any training, after the 6 weeks of training, respectively, and 1 and 3 months after the last training session, respectively
To measure motor function after stroke, ARAT will be performed in the human upper extremity. 19 Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch, and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally).
Change in intermuscular coordination patterns
时间窗: before any training, after the 6 weeks of training, respectively, and 1 and 3 months after the last training session, respectively
EMGs will be recorded from 12 muscles. To assess whether muscle-synergy guided and/or force-guided exercise induce changes in the composition of intermuscular coordination patterns, non-negative matrix factorization will be applied to EMGs to identify and compare ICoPs. The features from EMG are muscle synergy (motor module) composition and activation profiles.
次要结局
- Brain imaging data recording(before any training, after the 6 weeks of training, respectively, and 1 and 3 months after the last training session, respectively)
研究者
Jinsook Roh
Assistant Professor
University of Houston