[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stroke-patients-with-hemiplegia-or-hemiparesis-in-the-subacute-stage\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stroke-patients-with-hemiplegia-or-hemiparesis-in-the-subacute-stage":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100592933","the-effect-of-combined-transcranial-pulse-current-stimulation-tpcs-and-transcutaneous-electrical-nerve-stimulation-tens-on-lower-limb-motor-function-in-subacute-to-chronic-stroke-patients-with-hemiplegia-compensator-stroke-100592933",false,"NCT06999876","The Effect of Combined Transcranial Pulse Current Stimulation (tPCS) and Transcutaneous Electrical Nerve Stimulation (TENS) on Lower Limb Motor Function in Subacute to Chronic Stroke Patients With Hemiplegia (COMPENSATOR-Stroke)","The Effect of Combined Transcranial Pulse Current Stimulation (tPCS) and Transcutaneous Electrical Nerve Stimulation (TENS) on Lower Limb Motor Function in Subacute to Chronic Stroke Patients With Hemiplegia: A Double-blind, Sham-controlled, Randomized Controlled Study","COMPENSATOR","Inclusion Criteria:\n\n1. Participants aged 21 years old and below 80 years old with a clinically diagnosed first onset ischaemic stroke confirmed by imaging modalities such as computerised tomography (CT) or magnetic resonance imaging (MRI). Previous transient ischemic attack or clinically silent infarct detected by CT\u002FMRI are not considered as previous stroke.\n2. Participants within the subacute stage of stroke (Within 14 days from stoke onset)\n3. Able to walk with or without assistance\n4. Able to understand instructions and give informed consent\n\nExclusion Criteria:\n\n1. History of craniotomy or placement of implant materials\u002F device in the body that may affect NIBS including, but not limited to, deep brain stimulator, cardiac implant, cochlear implant\n2. Intracranial haemorrhage in the cortical regions\n3. History of epilepsy or seizures\n4. History of major depression and a history of psychotic disorders\n5. Contraindications to tPCS\u002FTENS e.g., pregnancy, presence of skin lesion at the intended treatment areas.\n6. Concurrent use of benzodiazepine pyschoactive class of drugs which may affect effects of tPCS\n7. Concurrent use of anti-seizure medications (ASMs) which may affect effects of tPCS\n8. Presence of significant cognitive impairment\u002F aphasia rendering patient unable to comply with the treatment protocol\n9. Presence of disabling comorbidities that compromises limb function such as orthopaedics or neurological pathologies other than stroke\n10. Previous treatments of the lower limb spasticity with botulinum toxin, or alcohol.\n11. Prior history of non-invasive brain stimulations","ALL","21 Years","79 Years",{"count":21,"type":22},90,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this study is to evaluate the effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in lower limb motor function recovery in stroke patients with hemiplegia or hemiparesis in the subacute stage.The main questions it aims to answer are:\n\nPrimary objective - To evaluate the effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in lower limb motor function recovery, in stroke patients with hemiplegia or hemiparesis in the subacute stage\n\nSecondary Objectives -\n\n1. To evaluate the effects of high frequency tPCS + TENS in treatment of lower limb spasticity related to stroke.\n2. To evaluate the effects of high frequency tPCS + TENS in gait function improvement post stroke, including walking speed, mobility, balance and walking endurance.\n3. To evaluate the effects of high frequency tPCS on pain, mood and QOL.\n\nResearchers will compare the effects of high frequency tPCS + TENS to a control group which involves intervention with Sham device stimulation + TENS.\n\nParticipants will:\n\n* Be identified, recruited and have baseline assessments during screening period\n* First undergo a mandatory 2-hour device training at Visit 2 to ensure device competence.\n* Proceed with up to 7 days of habituation for device use and tolerability.\n* Carry out daily intervention sessions of 30 minutes for 30 days at home or inpatient setting.\n* Phone call follow-up (Telephone\u002F Video Call Interview) 2 weeks post intervention\n* Clinic visit at day 30 post intervention with allowance of + 7 days for study assessments\n* Clinic visit at day 90 post intervention with allowance of +\u002F- 7 days for study assessments\n* Update study coordinators via messaging platforms with regards to device issues, adverse events, any other reporting or questions",[28],"Stroke Patients With Hemiplegia or Hemiparesis in the Subacute Stage",[30,31,32,33,34,35,36,37,38,39],"Transcranial Pulsed Current Simulation","Transcutaneous Electrical Nerve Stimulation","Lower limb motor function recovery","Spasticity","Gait dysfunction","Standing balance","Ambulation","Stroke","Hemiplegia","Hemiparesis","NOT_YET_RECRUITING","2025-05-23",{"date":43,"type":44},"2025-05-31","ACTUAL",{"date":43,"type":22},{"date":47,"type":22},"2026-12-31",{"name":49,"class":50},"National University Health System, Singapore","OTHER",2]