NCT07041775招募中不适用
MINT Conditioning to Improve Post-stroke Gait
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- 10-m walk test
研究概览
简要总结
This study will test the ability of myoelectric interface for neurorehabilitation (MINT) training to improve walking function.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at enrollment is 18 to 85
- •Leg impairment from unilateral stroke at least 6 months prior to screening
- •Severe to moderate gait impairment (ambulatory with a maximum walking speed of 0.8 m/s, i.e., half of normal speed)
- •Able to stand without assistance
- •Clinically observable gait asymmetry
- •Abnormal co-activation between adductor magnus and rectus femoris (R greater than or equal to 0.5)
排除标准
- •Cognitive impairment with at least moderately impaired attention on digit-span test, or unable to follow instructions of the MINT task
- •Visual impairment (such as hemianopia) preventing sufficient perception of the screen to play the games
- •Anesthesia or severe neglect in the affected leg, or visual hemineglect (score of 2 on the NIH Stroke Scale Extinction and Inattention subtest) that impairs ability to play the games
- •Participation in another study on the affected leg, or any pharmacological study, within 6 weeks of enrollment
- •Inability to understand or follow commands in English due to aphasia or other reason that makes it impossible to perform the training
- •Diffuse or multifocal infarcts
- •Substantial leg or other pain preventing participation for 60 minutes a day
- •Spasticity treatment (pharmacological or Botox) on the affected leg within past 3 months
- •Severe osteoporosis causing hip or other fractures
- •History of multiple falls within the last year, use of walker for balance, or falling during stance while in the lab in the first session.
- •Contracture limiting the range of motion of the leg
- •Current pregnancy
- •From the TMS portion of the study only: History of epilepsy in adulthood requiring antiseizure medications; recent/current alcoholism or benzodiazepine/barbiturate abuse or recent history of alcohol/benzodiazepine/barbiturate withdrawal, recent history of cocaine or amphetamine use, skull fractures or skull deficits, concussion within the last 6 months, unexplained recurring headaches, vagus nerve stimulator, cochlear implant, deep brain stimulator, intracranial/carotid stents, cardiac pacemaker/AICD.
研究组 & 干预措施
MINT group
Experimental
MINT training of two leg muscles
干预措施: myoelectric interface for neurorehabilitation (MINT) conditioning (Other)
Sham group
Sham Comparator
one muscle feedback
干预措施: One muscle myoelectric feedback (Other)
结局指标
主要结局
10-m walk test
时间窗: Baseline and 4 weeks
The 10-m walk test measures gait speed
次要结局
- 6-min walk test(Baseline and week 8)
- 10-m walk test(Baseline and week 8)
- MINT performance(each training session)
- Target muscle co-activation(Baseline and weeks 4 and 8)
研究者
Marc Slutzky
Professor of Neurology
Northwestern University
研究点 (4)
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