[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650591":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":41,"responsibleParty":55,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":26,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":79,"overallStatus":83,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Bangladesh Medical University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Robotic-Augmented Rehabilitation Group","EXPERIMENTAL","Participants will receive ZEPU-AI9 exoskeleton-assisted gait training in addition to standard-of-care rehabilitation. Exoskeleton sessions will be conducted 3 times per week for 12 weeks (45 minutes\u002Fsession, including donning, warm-up, structured gait training, and cool-down), supervised by trained physiatrists and physiotherapists with safety harness support. Training parameters will be progressively adjusted based on participant performance and tolerance. Standard rehabilitation (balance training, lower-limb strengthening, stretching, gait retraining) will continue in parallel per institutional protocol.",[13,14],"Device: ZEPU-AI9 Lower Limb Exoskeleton Gait Training","Behavioral: Standard-of-Care Rehabilitation",{"label":16,"type":17,"description":18,"interventionNames":19},"Usual Care Group","ACTIVE_COMPARATOR","Participants will receive standard-of-care rehabilitation alone (balance training, lower-limb strengthening, stretching, gait retraining) per institutional protocol, without ZEPU-AI9 exoskeleton-assisted training, over the 12-week study period.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","ZEPU-AI9 Lower Limb Exoskeleton Gait Training","A powered, dual-leg lower-limb exoskeleton (Shandong Zepu Medical Technology Co., Ltd.) that generates repeated physiological gait cycles via motorized hip and knee joints, supporting standing, sitting, stepping-in-place, and over-ground walking. Adjustable thigh\u002Fcalf length, height, waist width, joint angles, step length, and training duration accommodate individual anthropometrics. Participants will use the device 3 times per week for 12 weeks (45-minute sessions), supervised by trained physiatrists\u002Fphysiotherapists, with an overhead safety harness. Training parameters are progressively adjusted based on performance. Safety features include emergency stop, automated spasm protection, mechanical joint limits, overload detection, and anti-tilt protection. Used in addition to standard-of-care rehabilitation.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"BEHAVIORAL","Standard-of-Care Rehabilitation","Institutional standard rehabilitation therapy delivered by physiotherapists, comprising balance training, lower-limb strengthening exercises, stretching, and gait retraining, per Department of Physical Medicine and Rehabilitation protocol at Bangladesh Medical University. Received by all participants throughout the 12-week study period, either alone (Usual Care Group) or in combination with ZEPU-AI9 exoskeleton-assisted gait training (Robotic-Augmented Rehabilitation Group).",[9,16],[33],{"name":34,"affiliation":5,"role":35},"Md. Abdus Shakoor, Ph.D.","PRINCIPAL_INVESTIGATOR",[37],{"name":34,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+8801819410080","shakoorma@bmu.ac.bd",[42],{"facility":5,"status":26,"city":43,"state":26,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Dhaka","1000","Bangladesh","BD",{"type":48,"coordinates":49},"Point",[50,51],90.40744,23.7104,{"lat":51,"lon":50},[54],{"name":34,"role":38,"phone":39,"phoneExt":26,"email":40},{"type":35,"investigatorFullName":34,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Chairman & Professor, Department of Physical Medicine & Rehabilitation and Focal Person, Robotic Rehabilitation Centre, Bangladesh Medical University","100650591","zepu-ai9-exoskeleton-rehabilitation-robot-100650591",false,"NCT07750808","ZEPU AI9 Exoskeleton Rehabilitation Robot","Feasibility, Safety and Efficacy of ZEPU AI9 Lower Limb Exoskeleton Rehabilitation Robot in Patients With Lower Limb Motor Dysfunction","Inclusion Criteria:\n\n* Age ≥ 18 and ≤ 60 years.\n* Lower-limb motor dysfunction from one of the following: (a) stroke (onset 2-24 months), (b) incomplete spinal-cord injury (neurological level T12 and below, ASIA C or D), (c) orthopedic surgery (e.g., knee\u002Fhip replacement) with persistent gait impairment \\> 3months post-surgery.\n* Able to provide informed consent and understand instructions.\n* Weight ≤ 100 kg (as per device spec) and height within device adjustable range (manufacturer spec).\n* Medically stable and cleared by physician for exoskeleton use (no active infection, uncontrolled cardiac\u002Frespiratory disease, severe osteoporosis, uncontrolled epilepsy, untreated DVT) with necessary investigations.\n\nExclusion Criteria:\n\n* Complete spinal cord injury with inability to bear any weight.\n* Severe cognitive impairment (e.g., MMSE \\\u003C 24) preventing safe participation.\n* Severe spasticity (Modified Ashworth Scale \\> 3) in lower limbs.\n* Unstable fractures, severe hip\u002Fknee contractures (\\> 30° fixed flexion), severe osteoarthritis requiring imminent surgery.\n* Uncontrolled cardiac arrhythmia, pacemaker incompatibility, or implanted electronic device incompatible with robot sensors.\n* Pregnancy.","ALL","18 Years","60 Years",{"count":68,"type":69},36,"ESTIMATED","INTERVENTIONAL",[72],"NA","The goal of this clinical trial is to learn whether the ZEPU AI9 lower limb exoskeleton robot is feasible, safe, and effective for people with walking difficulty caused by stroke, incomplete spinal cord injury, or orthopedic surgery. The main questions it aims to answer are:\n\nIs exoskeleton-assisted gait training well tolerated, and how often do device-related problems (such as falls, pain, or skin injury) occur? Does adding exoskeleton training to usual rehabilitation improve walking distance, walking speed, balance, muscle strength, and joint movement compared with usual rehabilitation alone? Is it practical to add this robotic training into the rehabilitation program at Bangladesh Medical University?\n\nResearchers will compare a group receiving exoskeleton-assisted gait training plus standard rehabilitation to a group receiving standard rehabilitation alone, to see whether the exoskeleton adds benefit.\n\nParticipants will:\n\nBe randomly assigned to either the exoskeleton group or the standard-care group If assigned to the exoskeleton group, attend 45-minute training sessions 3 times a week for 12 weeks, supervised by physical therapists with safety harness support Both groups will continue their usual rehabilitation therapy throughout the study Undergo walking, balance, strength, and quality-of-life assessments at the start of the study and every 2 weeks for 12 weeks Be monitored for any side effects or safety concerns during and after each session",[75,76,77,78],"Stroke","Gait Disorders, Neurologic","Spinal Cord Injuries, Incomplete","Postoperative Complication",[80,81,82],"Lower limb exoskeleton","Robotic Rehabilitation","Neurorehabilitation","NOT_YET_RECRUITING","2026-08-06",{"date":86,"type":87},"2026-08-10","ACTUAL",{"date":89,"type":69},"2026-08",{"date":91,"type":69},"2026-12",{"name":5,"class":6},1]