Recruiting

Tele-Cross Education

Sponsor:

University of Illinois at Chicago

Code:

NCT07652970

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tele-CE

Tele-CE

Tele-Control

Study Details

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

Study ID

NCT07652970

Start date

Jun, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Tele-CE

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

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.

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 measure

  • 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). ]

Central Contacts and Locations

Locations

Brain Plasticity Lab

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Shravni Deshmukh

312-996-9056sdeshm20@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-06-17.