Effect of Home-based Cross-education on Lower Limb Neuroplasticity in Severe Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to determine the effects of home-based cross-education on lower limb neuroplasticity in severe stroke.
The main questions the investigators aim to answer are:
- What are the effects of home-based cross-education on lower limb neuroplasticity?
- What are the effects of home-based cross-education on lower limb function?
- Is home-based cross-education feasible to administer and accepted by participants?
Participants will take part in ten home-based, remotely supervised sessions, during which participants will either perform unilateral skill and strength training of the unaffected lower limb (Tele-Cross Education or Tele-CE) or cognitive training and unilateral movements of the unaffected lower limb (Tele-control). Each participant will experience measures of brain and spinal activity and motor function testing before and after both sessions (Tele-CE and Tele-control). Each participant will also be asked to fill out a feedback questionnaire to assess acceptability after intervention sessions (Tele-CE and Tele-control).
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single, monohemispheric stroke
- •Chronic stroke (> 6 months prior)
- •Severe stroke (Fugl-Meyer Lower Extremity motor scale score < 21 or 6 Minute Walk Test distance < 300m)
排除标准
- •Use of anti-spasticity medications
- •Existence of other neurological disorders
- •Have brainstem or cerebellar lesions.
- •Mini-Mental State Examiniation score of <21, to ensure participants have the cognitive capacity to consent and can understand instructions both in-person and during remote supervision.
- •Non-English-speaking individuals
- •Bone, joint or soft tissue injury
- •Uncontrolled medical conditions (such as uncontrolled hypertension, untreated cardiac disease, or untreated pulmonary disease)
- •Unable to see the tablet and zoom screen
- •Unable to move non-paretic ankle (< 5 degrees of ankle ROM)
- •Fugl-Meyer Lower Extremity sensory scale score < 6
- •TMS exclusion criteria
- •Previous adverse reaction to TMS
- •Skull abnormalities or fractures
- •Concussion within the prior 6 months
- •Unexplained, recurring headaches
- •Implanted cardiac pacemaker
- •Metal implants in the head or face
- •History of seizures or epilepsy
- •Use of medications that could alter cortical excitability or increase risk of seizure (e.g., antidepressants, antipsychotics, anxiolytics, anticonvulsants)
- •Current pregnancy
- •PNS exclusion criteria
- •Skin hypersensitivity at any sites of stimulation, including the scalp, thoracolumbar spine, and peripheral limbs
- •History of contact dermatitis at any of the sites of stimulation
- •History of allodynia and/or hyperalgesia
- •Active skin infection
- •Skin lesions
- •Deep vein thrombosis
- •Any other skin or scalp condition that could be aggravated by stimulation
- •Implanted electronic, metallic, or highly conductive devices near site of stimulation that cannot be removed without permission from a health professional
研究者
Sangeetha Madhavan
Professor
University of Illinois at Chicago