Tele-CE in Severe Stroke
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Illinois at Chicago
About 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Tele-CE
Other interventionSkilled dorsiflexion and plantarflexion movements of the unaffected ankle using a tablet-based system to play simple and engaging games.
Tele-CE
Other interventionUnilateral 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
Other interventionCognitive 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Tele-Cross Education (Tele-CE)Experimental treatment 1 intervention
Group B: Tele-ControlSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Changes will be calculated from baseline (pre) to immediately after the intervention (post).2
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.
Time frame
Changes will be calculated from baseline (pre) to immediately after the intervention (post).3
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.
Time frame
Changes will be calculated from baseline (pre) to immediately after the intervention (post).4
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.
Time frame
Changes will be calculated from baseline (pre) to immediately after the intervention (post).Secondary outcomes
1
Walking speed
Participants will complete the 10-Meter Walk Test (10MWT) on a flat, unobstructed walkway to measure walking speed.
Time frame
Changes will be calculated from baseline (pre) to immediately after the intervention (post).2
Walking endurance
Participants will perform 6-minute walk test (6MWT) to measure endurance.
Time frame
Changes will be calculated from baseline (pre) to immediately after the intervention (post).3
Physical activity levels
The investigators will use an activity monitor to measure daily step count and moderate to vigorous physical activity percent.
Time frame
Changes will be calculated from baseline (pre) to immediately after the intervention (post).4
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.
Time frame
Feedback will be collected immediately after the intervention (post).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov