Tele-CE in Severe Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tele-CE, Tele-CE, Tele-Control.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Home-based Cross-education on Lower Limb Neuroplasticity in Severe Stroke
Overview
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).
Interventions
- Other Tele-CE
Skilled dorsiflexion and plantarflexion movements of the unaffected ankle using a tablet-based system to play simple and engaging games. - Other Tele-CE
Unilateral lower limb strength training of the unaffected leg using a theraband targeting hip flexors, hip abductors, hip adductors, knee flexors, knee extensors, and ankle plantarflexors. - Other Tele-Control
Cognitive training using games focusing on memory and executive function along with unilateral leg movements of the unaffected hip flexors, hip abductors, hip adductors, knee flexors, knee extensors, and ankle plantarflexors.
Primary outcome measures
- Corticomotor excitability using transcranial magnetic stimulation (TMS) [Time frame: Changes will be calculated from baseline (pre) to immediately after the intervention (post).]
- Transcallosal Inhibition using transcranial magnetic stimulation (TMS) [Time frame: Changes will be calculated from baseline (pre) to immediately after the intervention (post).]
- Cutaneous reflex excitability using peripheral nerve stimulation (PNS) [Time frame: Changes will be calculated from baseline (pre) to immediately after the intervention (post).]
- Muscle Strength [Time frame: Changes will be calculated from baseline (pre) to immediately after the intervention (post).]
Secondary outcome measures (4)
- Walking speed [Time frame: Changes will be calculated from baseline (pre) to immediately after the intervention (post).]
- Walking endurance [Time frame: Changes will be calculated from baseline (pre) to immediately after the intervention (post).]
- Physical activity levels [Time frame: Changes will be calculated from baseline (pre) to immediately after the intervention (post).]
- Intervention acceptability [Time frame: Feedback will be collected immediately after the intervention (post).]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Brain Plasticity Lab — Chicago
Identifiers
NCT: NCT07652970 · 2025-0207 · 25PRE1372681