[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07652970":3,"trial-entities:NCT07652970":128,"trial-summary:NCT07652970":131},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":40,"secondary_outcomes":54,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":14,"eligibility_criteria":71,"std_ages":105,"locations":108,"central_contacts":124,"overall_officials":125,"references":126,"see_also_links":127},"NCT07652970","2025-0207","Tele-CE in Severe Stroke","Effect of Home-based Cross-education on Lower Limb Neuroplasticity in Severe Stroke","RECRUITING","2027-06","2026-06","2026-06-17","University of Illinois at Chicago","OTHER",false,"The goal of this clinical trial is to determine the effects of home-based cross-education on lower limb neuroplasticity in severe stroke.\n\nThe main questions the investigators aim to answer are:\n\n* What are the effects of home-based cross-education on lower limb neuroplasticity?\n* What are the effects of home-based cross-education on lower limb function?\n* Is home-based cross-education feasible to administer and accepted by participants?\n\nParticipants 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).",null,[18],"Stroke",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},40,"ESTIMATED",[28,33,36],{"type":13,"name":29,"description":30,"armGroupLabels":31},"Tele-CE","Skilled dorsiflexion and plantarflexion movements of the unaffected ankle using a tablet-based system to play simple and engaging games.",[32],"Tele-Cross Education (Tele-CE)",{"type":13,"name":29,"description":34,"armGroupLabels":35},"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.",[32],{"type":13,"name":37,"description":38,"armGroupLabels":39},"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.",[37],[41,45,48,51],{"measure":42,"description":43,"timeFrame":44},"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).",{"measure":46,"description":47,"timeFrame":44},"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.",{"measure":49,"description":50,"timeFrame":44},"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.",{"measure":52,"description":53,"timeFrame":44},"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.",[55,58,61,64],{"measure":56,"description":57,"timeFrame":44},"Walking speed","Participants will complete the 10-Meter Walk Test (10MWT) on a flat, unobstructed walkway to measure walking speed.",{"measure":59,"description":60,"timeFrame":44},"Walking endurance","Participants will perform 6-minute walk test (6MWT) to measure endurance.",{"measure":62,"description":63,"timeFrame":44},"Physical activity levels","The investigators will use an activity monitor to measure daily step count and moderate to vigorous physical activity percent.",{"measure":65,"description":66,"timeFrame":67},"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).","ALL","18 Years","80 Years",{"inclusion":72,"exclusion":76,"raw_text":104},[73,74,75],"Single, monohemispheric stroke","Chronic stroke (\\> 6 months prior)","Severe stroke (Fugl-Meyer Lower Extremity motor scale score \\\u003C 21 or 6 Minute Walk Test distance \\\u003C 300m)",[77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103],"Use of anti-spasticity medications","Existence of other neurological disorders","Have brainstem or cerebellar lesions.","Mini-Mental State Examiniation score of \\\u003C21, 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 (\\\u003C 5 degrees of ankle ROM)","Fugl-Meyer Lower Extremity sensory scale score \\\u003C 6","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","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\u002For 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","Inclusion Criteria:\n\n* Single, monohemispheric stroke\n* Chronic stroke (\\> 6 months prior)\n* Severe stroke (Fugl-Meyer Lower Extremity motor scale score \\\u003C 21 or 6 Minute Walk Test distance \\\u003C 300m)\n\nExclusion Criteria:\n\n* Use of anti-spasticity medications\n* Existence of other neurological disorders\n* Have brainstem or cerebellar lesions.\n* Mini-Mental State Examiniation score of \\\u003C21, to ensure participants have the cognitive capacity to consent and can understand instructions both in-person and during remote supervision.\n* Non-English-speaking individuals\n* Bone, joint or soft tissue injury\n* Uncontrolled medical conditions (such as uncontrolled hypertension, untreated cardiac disease, or untreated pulmonary disease)\n* Unable to see the tablet and zoom screen\n* Unable to move non-paretic ankle (\\\u003C 5 degrees of ankle ROM)\n* Fugl-Meyer Lower Extremity sensory scale score \\\u003C 6\n\nTMS exclusion criteria\n\n* Previous adverse reaction to TMS\n* Skull abnormalities or fractures\n* Concussion within the prior 6 months\n* Unexplained, recurring headaches\n* Implanted cardiac pacemaker\n* Metal implants in the head or face\n* History of seizures or epilepsy\n* Use of medications that could alter cortical excitability or increase risk of seizure (e.g., antidepressants, antipsychotics, anxiolytics, anticonvulsants)\n* Current pregnancy\n\nPNS exclusion criteria\n\n* Skin hypersensitivity at any sites of stimulation, including the scalp, thoracolumbar spine, and peripheral limbs\n* History of contact dermatitis at any of the sites of stimulation\n* History of allodynia and\u002For hyperalgesia\n* Active skin infection\n* Skin lesions\n* Deep vein thrombosis\n* Any other skin or scalp condition that could be aggravated by stimulation\n* Implanted electronic, metallic, or highly conductive devices near site of stimulation that cannot be removed without permission from a health professional",[106,107],"ADULT","OLDER_ADULT",[109],{"facility":110,"status":8,"city":111,"state":112,"zip":113,"country":114,"contacts":115,"geoPoint":121},"Brain Plasticity Lab","Chicago","Illinois","60612","United States",[116],{"name":117,"role":118,"phone":119,"email":120},"Shravni Deshmukh","CONTACT","312-996-9056","sdeshm20@uic.edu",{"lat":122,"lon":123},41.85003,-87.65005,[],[],[],[],{"nct_id":4,"conditions":129,"biomarkers":130},[18],[],{"nct_id":4,"found":14,"summary":16,"prompt_version":16}]