[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590912":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":56,"centralContacts":60,"locations":65,"responsibleParty":78,"collaborators":38,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":38,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":38,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":67,"whyStopped":38,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"The Hong Kong Polytechnic University","OTHER",[8,16,22,27],{"label":9,"type":10,"description":11,"interventionNames":12},"LIRT + BFR + TENS","EXPERIMENTAL","All subjects will receive 60-minute sessions of LIRT with both actual BFR and actual TENS intervention, 3 sessions per week for 6 weeks.",[13,14,15],"Device: Blood flow restriction (BFR)","Device: Transcutaneous electrical nerve stimulation (TENS)","Behavioral: Low-intensity resistance training (LIRT)",{"label":17,"type":18,"description":19,"interventionNames":20},"LIRT + sham BFR + TENS","SHAM_COMPARATOR","All subjects will receive 60-minute sessions of LIRT with simulated BFR and actual TENS, 3 sessions per week for 6 weeks.",[14,21,15],"Device: Sham blood flow restriction (Sham-BFR)",{"label":23,"type":18,"description":24,"interventionNames":25},"LIRT + BFR + sham TENS","All subjects will receive 60-minute sessions of LIRT with actual BFR and simulated TENS, 3 sessions per week for 6 weeks.",[13,26,15],"Device: Sham transcutaneous electrical nerve stimulation (Sham-TENS)",{"label":28,"type":29,"description":30,"interventionNames":31},"LIRT + sham BFR + sham TENS","PLACEBO_COMPARATOR","All subjects will receive 60-minute sessions of LIRT with simulated BFR and simulated TENS, 3 sessions per week for 6 weeks.",[21,26,15],[33,39,43,47,51],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DEVICE","Blood flow restriction (BFR)","BFR implementation involves an automated restriction band (SmartCuffs 4.0) positioned at the proximal region of the affected lower extremity, calibrated to 50% of the individual's lower limb occlusion pressure (LOP). The pressure system remains inflated throughout active training phases and is systematically deflated during inter-exercise intervals.",[9,23],null,{"type":34,"name":40,"description":41,"armGroupLabels":42,"otherNames":38},"Transcutaneous electrical nerve stimulation (TENS)","TENS will be delivered to the anterior thigh region of the paretic leg using a 120z Dual-Channel TENS Unit (ITO Physiotherapy \\& Rehabilittaion, Co, Ltd, Tokyo, Japan). The TENS stimulation will be at 100 Hz, with 0.2 ms square pulses at an intensity of twice the sensory threshold (defined as the minimum intensity at which subject reported feeling a tingling sensation and below the motor threshold as indicated by the absence of muscle twitching.",[9,17],{"type":34,"name":44,"description":45,"armGroupLabels":46,"otherNames":38},"Sham blood flow restriction (Sham-BFR)","Sham BFR implementation involves an automated restriction band (SmartCuffs 4.0) positioned at the proximal region of the affected lower extremity, calibrated to 50% of the individual's lower limb occlusion pressure (LOP). But the pressure system remains deflated throughout active training and resting phases.",[17,28],{"type":34,"name":48,"description":49,"armGroupLabels":50,"otherNames":38},"Sham transcutaneous electrical nerve stimulation (Sham-TENS)","Sham TENS will be delivered to the anterior thigh region of the paretic leg using a 120z Dual-Channel TENS Unit (ITO Physiotherapy \\& Rehabilittaion, Co, Ltd, Tokyo, Japan). The TENS stimulation will be at 100 Hz, with 0.2 ms square pulses at an intensity of twice the sensory threshold (defined as the minimum intensity at which subject reported feeling a tingling sensation and below the motor threshold as indicated by the absence of muscle twitching. But the stimulator will only be applied for the first and last 30 seconds.",[23,28],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":38},"BEHAVIORAL","Low-intensity resistance training (LIRT)","The LIRT protocol utilizes 20% of one-repetition maximum (1-RM) as the standardized training load. LIRT including leg extensions, leg presses, and load-bearing squats focused on the affected limb. Each resistance exercise consists of 3 sets of 20 repetitions with rest intervals.",[9,23,17,28],[57],{"name":58,"affiliation":5,"role":59},"Shamay NG, PhD","PRINCIPAL_INVESTIGATOR",[61],{"name":58,"role":62,"phone":63,"phoneExt":38,"email":64},"CONTACT","+852 27664889","shamay.ng@polyu.edu.hk",[66],{"facility":5,"status":67,"city":68,"state":38,"zip":38,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"RECRUITING","Hong Kong","HK",{"type":71,"coordinates":72},"Point",[73,74],114.17469,22.27832,{"lat":74,"lon":73},[77],{"name":58,"role":62,"phone":63,"phoneExt":38,"email":64},{"type":59,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Shamay Ng","Prof.","100590912","blood-flow-restriction-and-transcutaneous-electrical-nerve-stimulation-on-motor-function-in-stroke-100590912",false,"NCT06973590","Blood Flow Restriction and Transcutaneous Electrical Nerve Stimulation on Motor Function in Stroke","Effects of Low-intensity Resistance Training With Blood Flow Restriction and Transcutaneous Electrical Nerve Stimulation on Lower Limb Motor Function in People With Stroke","Inclusion Criteria:\n\n1. are between 50 and 80 years of age;\n2. have had a single stroke more than 6 months and less than 15 years;\n3. have at least 5 degrees of active ankle dorsiflexion in the antigravity position;\n4. are able to walk 10 m independently, with or without a walking aid;\n5. are able to score 6 or higher out of 10 on the abbreviated mental test;\n6. have no skin allergies (e.g. redness or itchiness after application of the electrical stimulation pads) to electrical stimulation or electrodes;\n7. are able to follow instructions and give informed consent.\n\nExclusion Criteria:\n\n1. presence of other comorbidities like varicose veins, peripheral neuropathy, cancer, musculoskeletal injury, lower limb peripheral edema, post-surgical swelling, open wounds, or on a medication that increases blood clotting risk;\n2. resting blood pressure ≥ 160\u002F100 mmHg even after taking medications, cardiovascular comorbidity, heart failure, unstable angina, by-pass surgery, a pacemaker;\n3. administration of botulinum toxin in the lower limb at least 6 months prior to training;\n4. history of epilepsy, cochlear implants, any type of deep brain stimulator and metal implants in the head or neck;\n5. currently not participating in resistance training or high-intensity or long duration cardiovascular exercise;\n6. lack the ability to feel pain (because of paralysis), or other subjects who cannot complain of discomfort.","ALL","50 Years","80 Years",{"count":92,"type":93},80,"ESTIMATED","INTERVENTIONAL",[96],"NA","Stroke commonly results in persistent leg impairments that limit mobility and reduce quality of life. This study investigates whether combining low-intensity resistance training with blood flow restriction (LIRT-BFR) and transcutaneous electrical nerve stimulation (TENS) can effectively improve leg function in stroke survivors.\n\nParticipants with chronic stroke will be randomly assigned to one of four intervention groups: 1) LIRT with simulated BFR and simulated TENS; 2) LIRT with actual BFR and simulated TENS; 3) LIRT with simulated BFR and actual TENS; 4) LIRT with both actual BFR and actual TENS. The resistance training utilizes 20% of each participant's maximum lifting capacity. For blood flow restriction, an automated pressure cuff (SmartCuffs 4.0) will be placed on the upper portion of the affected leg, inflated to 50% of the individual's occlusion pressure during exercises and deflated during rest periods. TENS therapy delivers controlled electrical impulses through electrodes positioned on the anterior thigh.\n\nEach 60-minute session includes a 10-minute warm-up followed by 40 minutes of targeted resistance exercises (leg extensions, leg presses, and weight-bearing squats) and concludes with 10 minutes of stationary cycling. The resistance protocol involves 3 sets of 20 repetitions with standardized rest intervals between sets and exercises. Participants will attend three sessions weekly for six weeks.\n\nAssessments will be conducted at baseline, midpoint (3 weeks), completion (6 weeks), and follow-up (1 month post-intervention). The primary outcome measure is the Fugl-Meyer Assessment for Lower Extremity function, with secondary measures including muscle strength, stiffness, balance, mobility, walking capacity, and gait parameters. To understand the underlying mechanisms, we will measure muscle oxygenation using near-infrared spectroscopy, evaluate muscle structure via ultrasound, and monitor physiological responses including heart rate variability and perceived exertion for safety monitoring.",[99],"Chronic Stroke",[101,102,103,104],"blood flow restriction","transcutaneous electrical nerve stimulation","stroke","low-intensity resistance training","2025-05-07",{"date":107,"type":108},"2025-05-15","ACTUAL",{"date":110,"type":108},"2024-09-01",{"date":112,"type":93},"2026-12-31",{"name":5,"class":6},1]