[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522002":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":41,"centralContacts":45,"locations":51,"responsibleParty":65,"collaborators":67,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":32,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":32,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":53,"whyStopped":32,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Tan Tock Seng Hospital","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional supervised occupational therapy (CT)","SHAM_COMPARATOR","CT consists of standard occupational therapy for hand function which includes but not limited to the following treatment (1) passive and active mobilisation; (2) spasticity management; (3) training with use of various modalities\u002Fequipment; (4) gross and fine motor training including reach and grasp\u002Frelease functions, and object manipulation; (5) grasp training: cylindrical, spherical, intrinsic, 2-finger pincer and 3-finger grip.",[13],"Other: Standard Treatment of Care",{"label":15,"type":16,"description":17,"interventionNames":18},"HandyRehab (HR) with supervised training by OT","ACTIVE_COMPARATOR","HR training consists of (1) passive and active mobilisation (2) spasticity management (3) gross motor training with HR applied (4) grasp training: cylindrical, spherical, intrinsic, 2-finger pincer and 3-finger grip.",[19,13],"Device: HandyRehab (HR)",{"label":21,"type":22,"description":23,"interventionNames":24},"HandyRehab integrated with BCI (BCI-HR) with supervised training by OT","EXPERIMENTAL","BCI-HR training consists of (1) passive and active mobilisation (2) spasticity management (3) gross motor training with BCI-HR applied (4) grasp training: cylindrical, spherical, intrinsic, 2-finger pincer and 3-finger grip.",[25,13],"Device: Brain Computer Interface integrated HandyRehab platform (BCI-HR)",[27,33,37],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DEVICE","Brain Computer Interface integrated HandyRehab platform (BCI-HR)","To test the usability, safety and efficacy of an experimental prototype of a wearable hand robotic glove integrated with brain computer interface system being developed and researched.",[21],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"HandyRehab (HR)","A wearable hand robotic glove approved by Health Sciences Authority, class I commercial device",[15],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"Standard Treatment of Care","Standard Conventional Occupational Therapy",[9,15,21],[42],{"name":43,"affiliation":5,"role":44},"Karen Chua","PRINCIPAL_INVESTIGATOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":32,"email":50},"Low Ai Mei Jaclyn","CONTACT","68894580","Jaclyn_AM_LOW@ttsh.com.sg",[52],{"facility":5,"status":53,"city":54,"state":54,"zip":55,"country":54,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Singapore","308433","SG",{"type":58,"coordinates":59},"Point",[60,61],103.85007,1.28967,{"lat":61,"lon":60},[64],{"name":47,"role":48,"phone":32,"phoneExt":32,"email":50},{"type":66,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[68,70,73],{"name":69,"class":6},"Nanyang Technological University",{"name":71,"class":72},"Singapore University of Technology & Design","UNKNOWN",{"name":74,"class":6},"National University of Singapore","100522002","brain-computer-interface-bci-integrated-wearable-hand-robotic-glove-system-for-upper-limb-stroke-rehabilitation-100522002",false,"NCT06076928","Brain Computer Interface (BCI) Integrated Wearable Hand Robotic Glove System for Upper Limb Stroke Rehabilitation","Brain Computer Interface (BCI) Integrated Wearable Hand Robotic Glove System for Upper Limb Stroke Rehabilitation: A 3-arm Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age 21-85 years, males and females\n2. First diagnosis of stroke (ischemic or haemorrhagic), confirmed by neurologist\u002Fneurosurgeon\u002FCT\u002FMRI imaging\n3. \\> 16 weeks post stroke\n4. Hemiplegic pattern of post-stroke weakness\n5. MRC ≥ 2\u002F5 motor power and above for shoulder abduction \\& elbow flexion\n6. MRC 0 to 4\u002F5 motor power and above for finger flexors \\&\u002For extensors of thumb, index, middle fingers\n7. Screening Fugl-Meyer wrist hand sub score \\\u003C18\u002F24\n8. Spasticity MAS \\\u003C3 for thumb, index, and middle fingers\n9. Able to discriminate thumb and index sensation to pain\n10. Hand sizes within 170-200mm (length) \\&75-85mm (width), compatible with HandyRehab robotic glove\n11. BCI compatible brain states using a standardised screening protocol\n12. Able to understand simple commands with Mini Mental state examination scores MMSE \\> 21\u002F30)\n13. Able to give informed consent\n\n    * Subjects who are unable to clear BCI screening 11. will be randomised to either CT or HR groups.\n\nExclusion Criteria:\n\nNeurological\n\n* Recurrent stroke\n* Diagnosis of neurodegenerative disease; e.g. Parkinson's' disease, Dementia, ALS\n\nMedical:\n\n\\- unstable medical or neurological conditions, life expectancy \\\u003C6 months, end-organ renal failure on dialysis, severe heart failure, postural hypotension, history of uncontrolled sepsis, epilepsy with seizure within 3 months of informed consent, skin conditions which could potentially be worsened by wearable robot (ulcers, open wounds, eczema, infections etc)\n\nPostural:\n\n* Unable to tolerate upright posture or sit unaided for \\\u003C 90min with rest breaks\n* Cognitive\u002Fbehavioural\u002Fvisual:\n* Severe dysphasia\u002Faphasia, severe visual neglect\u002Fblindness, untreated severe depression, psychiatric illness, unable to understand study requirements\n\nUpper limb:\n\n* Moderate to severe spasticity (Modified Ashworth scale MAS ≥2)\n* Hand\u002Farm related pain (VAS Pain ≥ 5\u002F10),\n* Presence of finger contractures, reduced functional range of motion, limiting functional wrist\u002Ffinger movements, active fractures or arthritis with deformities\n* Severe limb ataxia\u002Fapraxia\n* Severe post stroke hemi-anaesthesia in affected UE\n\nBCI incompatibility:\n\n* Motor imagery EEG signals unable to be detected\n* Presence of craniectomy skull defect (affecting BCI cap fit and electrode contact)\n* Concomitant participation in other interventional research trials\n* Resident of nursing home or overseas country which may compromise attendance at research site\n* Pregnant or lactating females will not be allowed to participate","ALL","21 Years","85 Years",{"count":86,"type":87},60,"ESTIMATED","INTERVENTIONAL",[90],"NA","Upper extremity (UE) recovery remains a huge rehabilitation challenge with largely incomplete recovery of the upper limb post stroke. This is due to heavier priorities placed on other stroke competencies such as mobility, activities of daily living training and home integration which results in suboptimal amounts of time spent in upper limb training post stroke.\n\nIn this study the investigators plan to pilot brain computer interface (BCI) integrated wearable hand robotic glove (HandyRehab) system for upper limb stroke rehabilitation.",[93],"Stroke",[95,96],"Brain Computer Interface","Hand exoskeleton robot","2025-09-02",{"date":99,"type":100},"2025-09-09","ACTUAL",{"date":102,"type":100},"2024-08-01",{"date":104,"type":87},"2026-01",{"name":5,"class":6},1]