No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
University of Illinois at Chicago · Other
Who this trial is looking for
This trial is looking for people who have had a severe stroke more than six months ago. Participants will do home exercises with remote support to improve their lower limb function and brain activity.
Are You a Good Fit for This Trial?
You may be able to join if
I have had a stroke that affects one side of my body.
My stroke happened more than six months ago.
My stroke is considered severe.
I can understand instructions during remote sessions.
You may not be able to join if
I use medications for muscle stiffness.
I have other neurological disorders.
I have a history of brain injuries or lesions.
I cannot see a tablet screen.
I cannot move my non-injured ankle.
I have uncontrolled medical conditions.
I do not speak English.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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).
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria:
* 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)
Exclusion Criteria:
* Use of anti-spasticity medications
* Existence of other neurological disorder…
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
Contacts
No contact information available.
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