Tele-CE in Severe Stroke

NCT07652970 | Recruiting

• 2 other identifiers: 2025-020725PRE1372681
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Walking speed

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

• Walking endurance

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

• Physical activity levels

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

• Intervention acceptability

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

Study Arms (2)

Tele-Cross Education (Tele-CE)

EXPERIMENTAL

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

Tele-Control

SHAM COMPARATOR

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

Interventions

Tele-CE OTHER

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

Tele-Cross Education (Tele-CE)

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.

Tele-Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Previous adverse reaction to TMS
• Skull abnormalities or fractures
• Concussion within the prior 6 months
• Unexplained, recurring headaches
• Implanted cardiac pacemaker

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

Brain Plasticity Lab

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 17, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)