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NCT Number: NCT07652970

Tele-CE in Severe Stroke

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).

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brain Plasticity Lab

Chicago, Illinois, 60612, United States

Location status: Recruiting

Location contact

Shravni Deshmukh

CONTACT

[email protected]

312-996-9056

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tele-CE

Other

Skilled dorsiflexion and plantarflexion movements of the unaffected ankle using a tablet-based system to play simple and engaging games.

Tele-Control

Other

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 outcomes

  1. Corticomotor excitability using transcranial magnetic stimulation (TMS)

    Time frame: Changes will be calculated from baseline (pre) to immediately after the intervention (post).

    Single-pulse transcranial magnetic stimulation (TMS) will be used to assess the corticomotor excitability from the tibialis anterior muscle. Higher values indicate more corticomotor excitability.

  2. Transcallosal Inhibition using transcranial magnetic stimulation (TMS)

    Time frame: Changes will be calculated from baseline (pre) to immediately after the intervention (post).

    Inhibition from the stimulated hemisphere to the non-stimulated hemisphere will be quantified as a measure of the ipsilateral silent period (iSP) using single pulse transcranial magnetic stimulation (TMS) and motor evoked potentials (MEPs) will be recorded from the tibialis anterior muscle of the leg ipsilateral to TMS stimulation. Higher values indicate more inhibition from the stimulated hemisphere to the non-stimulated hemisphere.

  3. Cutaneous reflex excitability using peripheral nerve stimulation (PNS)

    Time frame: Changes will be calculated from baseline (pre) to immediately after the intervention (post).

    Peripheral nerve stimulation (PNS) will be used to assess the cutaneous reflexes excitability from the deep peroneal nerve.

  4. Muscle Strength

    Time frame: Changes will be calculated from baseline (pre) to immediately after the intervention (post).

    Muscle strength of the affected and unaffected hip flexors, hip abductors, hip adductors, knee flexors, knee extensors, ankle dorsiflexors and ankle plantarflexors will be measured using handheld dynamometry.

Secondary outcomes

  1. Walking speed

    Time frame: Changes will be calculated from baseline (pre) to immediately after the intervention (post).

    Participants will complete the 10-Meter Walk Test (10MWT) on a flat, unobstructed walkway to measure walking speed.

  2. Walking endurance

    Time frame: Changes will be calculated from baseline (pre) to immediately after the intervention (post).

    Participants will perform 6-minute walk test (6MWT) to measure endurance.

  3. Physical activity levels

    Time frame: Changes will be calculated from baseline (pre) to immediately after the intervention (post).

    The investigators will use an activity monitor to measure daily step count and moderate to vigorous physical activity percent.

  4. Intervention acceptability

    Time frame: Feedback will be collected immediately after the intervention (post).

    Acceptability will be assessed through one custom semi-structured patient feedback questionnaire that includes domains of perceived satisfaction. Higher values indicate higher participant acceptability and perceived satisfaction of the intervention.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

Effect of Home-based Cross-education on Lower Limb Neuroplasticity in Severe Stroke

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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