Tele-CE in Severe Stroke

Effect of Home-based Cross-education on Lower Limb Neuroplasticity 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).

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Tele-CE; Other: Tele-CE; Other: Tele-Control

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Brain Plasticity Lab
      • Contact: Shravni Deshmukh; Phone Number: 312-996-9056; Email: sdeshm20@uic.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tele-Cross Education (Tele-CE); While seated, participants will begin with 15 minutes of game-based ankle skill training of the unaffected lower limb. Participants will perform skilled dorsiflexion and plantarflexion movements of the unaffected ankle to play simple and engaging games. Three game blocks will be played (5 mins/block) with 1-minute rest between blocks. Following this, participants will engage in unaffected leg strength training using a theraband targeting hip flexors, hip abductors, hip adductors, knee flexors, knee extensors, and ankle plantarflexors. Participants will perform 3 sets of 10 repetitions for each muscle group.	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.
Sham Comparator: Tele-Control; While seated, participants will begin with 15 minutes of cognitive training using games focusing on memory and executive function. Participants will play three cognitive games (5 minutes each with 1-min rest between blocks). Following this, participants will engage in unilateral leg movements of the unaffected hip flexors, hip abductors, hip adductors, knee flexors, knee extensors, and ankle plantarflexors. Participants will perform 3 sets of 10 repetitions of movements for each muscle group.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corticomotor excitability using transcranial magnetic stimulation (TMS)	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.	Changes will be calculated from baseline (pre) to immediately after the intervention (post).
Transcallosal Inhibition using transcranial magnetic stimulation (TMS)	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.	Changes will be calculated from baseline (pre) to immediately after the intervention (post).
Cutaneous reflex excitability using peripheral nerve stimulation (PNS)	Peripheral nerve stimulation (PNS) will be used to assess the cutaneous reflexes excitability from the deep peroneal nerve.	Changes will be calculated from baseline (pre) to immediately after the intervention (post).
Muscle Strength	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.	Changes will be calculated from baseline (pre) to immediately after the intervention (post).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking speed	Participants will complete the 10-Meter Walk Test (10MWT) on a flat, unobstructed walkway to measure walking speed.	Changes will be calculated from baseline (pre) to immediately after the intervention (post).
Walking endurance	Participants will perform 6-minute walk test (6MWT) to measure endurance.	Changes will be calculated from baseline (pre) to immediately after the intervention (post).
Physical activity levels	The investigators will use an activity monitor to measure daily step count and moderate to vigorous physical activity percent.	Changes will be calculated from baseline (pre) to immediately after the intervention (post).
Intervention acceptability	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.	Feedback will be collected immediately after the intervention (post).

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 2025-0207; 25PRE1372681 (Other Grant/Funding Number: American Heart Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No