Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Wolf Motor Function Test
研究概览
简要总结
The purpose of the study is to explore the feasibility of using a wearable device, called a myoelectric-computer interface (MCI), to improve arm movement in people who have had a stroke.
Impaired arm movement after stroke is caused not just by weakness, but also by impaired coordination between joints due to abnormal co-activation of muscles. These abnormal co-activation patterns are thought to be due to abnormal movement planning.The MCI aims to reduce abnormal co-activation by providing feedback about individual muscle activations.
This randomized, controlled, blinded study will test the home use of an MCI in chronic and acute stroke survivors.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be blinded as to sham vs. intervention, but not as to which interventional arm.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic stroke participants
- •Hemiparesis from first ever stroke at least 6 months prior to screening
- •Severe motor impairment (FMA of 7-30)
- •At least some voluntary shoulder and elbow muscle activation.
- •Acute stroke participants
- •Hemiparesis from first ever stroke within the past 21 days
- •Severe motor impairment (FMA of 3-20), or total Manual Motor Score of 1-8 combined in Shoulder Abduction and Finger Extensors
排除标准
- •Cognitive impairment with at least moderately impaired attention, or unable to follow instructions of the MCI task
- •Visual impairment (such as hemianopia) preventing full view of the screen
- •Anesthesia or neglect in the affected arm, or visual hemineglect (score of 2 on the NIH Stroke Scale Extinction and Inattention subtest).
- •Participation in another study on the affected arm within 6 weeks of enrollment or any pharmacological study
- •Inability to understand or follow commands in English due to aphasia or other reason
- •Diffuse or multifocal infarcts
- •Substantial arm pain preventing participation for 90 minutes a day
- •New spasticity treatment (pharmacological or Botox)
研究组 & 干预措施
Chronic stroke MCI Electromyogram (EMG) pairs
Decoupling 2 muscles at a time with MCI
干预措施: MCI (Behavioral)
Chronic stroke MCI EMG triplets
Decoupling 3 muscles at a time with MCI
干预措施: MCI (Behavioral)
Chronic stroke MCI while reaching
Decoupling muscles with MCI while reaching to targets
干预措施: MCI (Behavioral)
Chronic stroke Sham MCI
Sham control group
干预措施: Sham MCI (Behavioral)
Acute stroke MCI
Decoupling muscles with MCI in acute stroke subjects
干预措施: MCI (Behavioral)
Acute stroke Sham MCI
Acute stroke subjects sham comparator
干预措施: Sham MCI (Behavioral)
结局指标
主要结局
Wolf Motor Function Test
时间窗: baseline to 6 weeks
Timed
次要结局
- Fugl-Meyer Assessment UE(baseline to 10 weeks)
- Fugl-Meyer Assessment - Upper Extremity (UE)(baseline to 6 weeks)
- Motor Activity Log(baseline to 6 weeks)
- Modified Ashworth Scale(baseline to 6 weeks)
- Wolf Motor Function Test(baseline to 10 weeks)
研究者
Marc Slutzky
Associate Professor
Northwestern University