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| ID | Type | Description | Link |
|---|---|---|---|
| 25PRE1372681 | Other Grant/Funding Number | American Heart Association |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele-CE | Other | Skilled dorsiflexion and plantarflexion movements of the unaffected ankle using a tablet-based system to play simple and engaging games. |
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| 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). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
TMS exclusion criteria
PNS exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain Plasticity Lab | Recruiting | Chicago | Illinois | 60612 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Tele-CE | Other | 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. |
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| 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. |
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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). |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |