[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650652":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":47,"centralContacts":51,"locations":56,"responsibleParty":72,"collaborators":29,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":29,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":29,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":97,"overallStatus":101,"whyStopped":29,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Bangladesh Medical University","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Robotic-Augmented Rehabilitation (Intervention)","EXPERIMENTAL","Participants (n=18 per device cohort) receive standard-of-care physiotherapy plus robotic-assisted rehabilitation using the ZEPU-AI2, AI4, AI6 Plus, or AI7A system, 3 sessions\u002Fweek (\\~45 min each) for 12 weeks (36 sessions total), including warm-up, device donning, structured training (upper\u002Flower limb, gait, or isokinetic depending on device), and cool-down, delivered under supervision of trained physiotherapists.",[13,14,15,16,17],"Device: ZEPU-AI2","Device: ZEPU-AI4","Device: ZEPU-AI6 Plus","Device: ZEPU-AI7A","Behavioral: Standard-of-Care Physiotherapy",{"label":19,"type":20,"description":21,"interventionNames":22},"Usual Care (Control)","ACTIVE_COMPARATOR","Participants (n=18 per device cohort) receive standard-of-care rehabilitation alone (balance training, lower-limb strengthening, stretching, and gait retraining as per institutional protocol) without the addition of robotic-assisted therapy.",[17],[24,30,34,38,42],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","ZEPU-AI2","Upper Extremity Feedback Training and Evaluation System Intervention Description: Robotic upper-extremity feedback training and evaluation device enabling active, passive, and active-assisted movement training with real-time feedback for patients with upper-limb motor dysfunction, used 3 sessions\u002Fweek for 12 weeks in addition to standard physiotherapy.",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"ZEPU-AI4","Multi-Joint Isokinetic Training and Evaluation System Intervention Description: Robotic multi-joint isokinetic training and evaluation device supporting controlled, resistance-based rehabilitation and objective strength assessment of upper- and lower-limb joints, used 3 sessions\u002Fweek for 12 weeks in addition to standard physiotherapy.",[9],{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"ZEPU-AI6 Plus","Multi-axis robotic arm device that simulates physiological upper-limb movement patterns for three-dimensional active and passive training, used 3 sessions\u002Fweek for 12 weeks in addition to standard physiotherapy.",[9],{"type":25,"name":39,"description":40,"armGroupLabels":41,"otherNames":29},"ZEPU-AI7A","Motor-driven robotic device providing active and passive rehabilitation of the upper and lower limbs, separately or simultaneously, via circular motion training, used 3 sessions\u002Fweek for 12 weeks in addition to standard physiotherapy.",[9],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":29},"BEHAVIORAL","Standard-of-Care Physiotherapy","Conventional physiotherapy comprising balance training, lower-limb strengthening, stretching, and gait retraining delivered per institutional protocol; provided alone in the control arm and alongside robotic training in the intervention arm.",[9,19],[48],{"name":49,"affiliation":5,"role":50},"Md. Abdus Shakoor, Ph.D.","PRINCIPAL_INVESTIGATOR",[52],{"name":49,"role":53,"phone":54,"phoneExt":29,"email":55},"CONTACT","+8801819410080","shakoorma@bmu.ac.bd",[57],{"facility":5,"status":29,"city":58,"state":29,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Dhaka","1000","Bangladesh","BD",{"type":63,"coordinates":64},"Point",[65,66],90.40744,23.7104,{"lat":66,"lon":65},[69],{"name":49,"role":53,"phone":70,"phoneExt":29,"email":71},"01711222912","shakoorma@bsmmu.edu.bd",{"type":50,"investigatorFullName":49,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Chairman & Professor, Department of Physical Medicine & Rehabilitation and Focal Person, Robotic Rehabilitation Centre, Bangladesh Medical University","100650652","zepu-ai-series-limb-feedback-robot-training-study-zepuaisrct-100650652",false,"NCT07749625","ZEPU-AI Series Limb Feedback Robot Training Study (ZEPUAISRCT)","Feasibility, Safety and Efficacy of ZEPU-AI2, AI4, AI6 Plus and AI7A Robotic Rehabilitation Systems in Patients With Upper and Lower Limb Motor Dysfunction","Inclusion Criteria:\n\n* Presence of upper-limb motor dysfunction, with or without concurrent lower-limb impairment, due to one of the following conditions: (a) Stroke, with onset between 2 and 24 months prior to enrollment; (b) Incomplete spinal cord injury (ASIA Scale B, C, or D); (c) Traumatic brain injury; or (d) Orthopedic disorders affecting upper and\u002For lower limb motor function\n* Age between 18 and 60 years\n* Ability to understand study procedures and follow instructions, and to provide written informed consent (or assent with guardian consent where applicable)\n* Body weight and limb anthropometry compatible with ZEPU-AI2, AI4, AI6 Plus, and AI7A systems, as per manufacturer specifications\n* Medically stable and cleared by a physician for robotic rehabilitation, with no active infection, uncontrolled cardiac or respiratory disease, severe osteoporosis, uncontrolled epilepsy, or untreated deep vein thrombosis\n\nExclusion Criteria:\n\n* Complete spinal cord injury or profound motor paralysis preventing safe interaction with robotic devices\n* Severe cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score \\\u003C 24, that would compromise safe participation\n* Severe spasticity of the upper limb, defined as a Modified Ashworth Scale score \\> 3\n* Unstable fractures, severe fixed joint contractures of the shoulder, elbow, wrist, or hand (e.g., \\> 30°), or severe pain limiting safe robotic training\n* Uncontrolled cardiac arrhythmia, presence of a pacemaker, or other implanted electronic medical devices incompatible with robotic sensors\n* Pregnancy","ALL","18 Years","60 Years",{"count":85,"type":86},36,"ESTIMATED","INTERVENTIONAL",[89],"NA","The goal of this clinical trial is to learn whether robotic rehabilitation devices (ZEPU-AI2, AI4, AI6 Plus, and AI7A) are feasible, safe, and effective for adults with upper or lower limb motor problems. These problems can result from stroke, incomplete spinal cord injury, traumatic brain injury, or orthopedic surgery. The main questions it aims to answer are:\n\nIs robotic rehabilitation training safe and practical to deliver alongside conventional therapy? Does adding robotic-assisted therapy improve motor function, balance, gait, and independence in daily activities compared to conventional rehabilitation alone? What side effects or device-related problems, if any, occur during robotic training?\n\nThe Investigators will compare a robotic-augmented rehabilitation group to a control group receiving conventional rehabilitation alone, to see if adding robotic therapy leads to better recovery.\n\nParticipants will:\n\nReceive robotic-assisted therapy sessions three times a week for 12 weeks, each lasting about 45 minutes (robotic group), or continue with conventional rehabilitation alone (control group) Undergo assessments of movement, balance, walking ability, and daily function before and after the study period Be monitored for any side effects or complications related to the device or training",[92,93,94,95,96],"Stroke","Spinal Cord Injuries","Brain Injuries, Traumatic","Movement Disorder, Upper Extremity","Movement Disorder, Lower Extremity",[98,26,31,35,39,99,100],"Robotic Rehabilitation","Neurorehabilitation","Musculoskeletal Rehabilitation","NOT_YET_RECRUITING","2026-08-04",{"date":104,"type":105},"2026-08-06","ACTUAL",{"date":107,"type":86},"2026-08",{"date":109,"type":86},"2026-11",{"name":5,"class":6},1]