Stroke
Conditions
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).
Interventions
OTHERTele-CE
Skilled dorsiflexion and plantarflexion movements of the unaffected ankle using a tablet-based system to play simple and engaging games.
OTHERTele-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.
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corticomotor excitability using transcranial magnetic stimulation (TMS) | Changes will be calculated from baseline (pre) to immediately after the intervention (post). | 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. |
| Transcallosal Inhibition using transcranial magnetic stimulation (TMS) | Changes will be calculated from baseline (pre) to immediately after the intervention (post). | 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. |
| Cutaneous reflex excitability using peripheral nerve stimulation (PNS) | Changes will be calculated from baseline (pre) to immediately after the intervention (post). | Peripheral nerve stimulation (PNS) will be used to assess the cutaneous reflexes excitability from the deep peroneal nerve. |
| Muscle Strength | Changes will be calculated from baseline (pre) to immediately after the intervention (post). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Walking speed | Changes will be calculated from baseline (pre) to immediately after the intervention (post). | Participants will complete the 10-Meter Walk Test (10MWT) on a flat, unobstructed walkway to measure walking speed. |
| Walking endurance | Changes will be calculated from baseline (pre) to immediately after the intervention (post). | Participants will perform 6-minute walk test (6MWT) to measure endurance. |
| Physical activity levels | Changes will be calculated from baseline (pre) to immediately after the intervention (post). | The investigators will use an activity monitor to measure daily step count and moderate to vigorous physical activity percent. |
| Intervention acceptability | Feedback will be collected immediately after the intervention (post). | 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. |
Countries
United States
Outcome results
None listed