40 Participants NeededMy employer runs this trial

Tele-CE for Severe Stroke

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Are You a Good Fit for This Trial?

This trial is for adults who had a single, severe stroke over 6 months ago affecting one side of the brain. Participants must have significant lower limb weakness but still be able to move their unaffected ankle. People with certain medical devices, skin issues, recent seizures or concussions, other neurological disorders, or trouble understanding instructions cannot join.

Inclusion Criteria

I had a stroke more than 6 months ago.
I have had one stroke affecting only one side of my brain.
I have had a severe stroke affecting my ability to walk or move my legs.

Exclusion Criteria

My lower limb sensation score is less than 6 on the Fugl-Meyer scale.
I have skin lesions.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in ten home-based, remotely supervised sessions of either Tele-Cross Education or Tele-Control, including skill and strength training or cognitive training and unilateral movements.

10 sessions
Remote supervision

Assessment

Measures of brain and spinal activity and motor function testing are conducted before and after intervention sessions.

Immediately before and after intervention

Follow-up

Participants are monitored for changes in corticomotor excitability, transcallosal inhibition, cutaneous reflex excitability, muscle strength, walking speed, walking endurance, and physical activity levels.

Immediately after intervention

Feedback

Participants complete a feedback questionnaire to assess acceptability and perceived satisfaction of the intervention.

Immediately after intervention

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares two types of home-based training done through video calls: one group does skill and strength exercises with their stronger leg (Tele-CE), while the other does cognitive tasks and simple movements (Tele-control). Both groups are supervised remotely and tested before and after sessions.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Tele-Cross Education (Tele-CE)Experimental Treatment1 Intervention
Group II: Tele-ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+