[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649539":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":38,"responsibleParty":52,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":80,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Bangladesh Medical University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Robotic-Augmented Rehabilitation Group","EXPERIMENTAL","Participants (n=16) will receive robot-assisted gait training using the ZEPU-AI1 Gait Training and Evaluation System in addition to standard-of-care rehabilitation. Training will be delivered 3 times per week for 12 weeks (36 sessions total), each session approximately 45 minutes, including warm-up, device donning, structured standing and gait training (sit-to-stand, in-place stepping, overground walking, turning), and cool-down. Body-weight support, walking speed, and session duration will be progressively adjusted based on participant tolerance and performance. Sessions will be supervised by trained physiatrists and physiotherapists at the Robotic Rehabilitation Centre, BMU. Standard-of-care rehabilitation (individualized rehabilitation and exercise) will continue in parallel.",[13,14],"Device: ZEPU-AI1 Gait Training and Evaluation System","Behavioral: Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise)",{"label":16,"type":17,"description":18,"interventionNames":19},"Usual Care (Control) Group","ACTIVE_COMPARATOR","Participants (n=16) will receive standard-of-care rehabilitation alone, without robotic-assisted gait training. This includes individualized rehabilitation and exercise (IRR) as per institutional protocol at the Department of Physical Medicine and Rehabilitation, BMU, matched in overall therapeutic content to the conventional-therapy component received by the intervention group.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","ZEPU-AI1 Gait Training and Evaluation System","Participants will receive robot-assisted gait training using the ZEPU-AI1 Gait Training and Evaluation System, a robotic device providing body-weight-supported, guided gait training. Training will be delivered 3 times per week for 12 weeks (36 sessions total), approximately 45 minutes per session, including warm-up, device donning, structured standing and gait training (sit-to-stand, in-place stepping, overground walking, turning), and cool-down. Body-weight support, walking speed, and session duration will be progressively adjusted based on participant tolerance and performance",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"BEHAVIORAL","Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise)","Participants will receive individualized rehabilitation and exercise (IRR) as per institutional protocol at the Department of Physical Medicine and Rehabilitation, BMU. This standard-of-care rehabilitation program is tailored to each participant's functional status and needs, and is matched in overall therapeutic content and intensity across both study groups. It is delivered without any robotic-assisted device and represents the conventional-therapy component of care for individuals undergoing gait and mobility rehabilitation.",[9,16],[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Md. Abdus Shakoor, Ph.D.","CONTACT","+8801819410080","shakoorma@bmu.ac.bd",[39],{"facility":5,"status":26,"city":40,"state":26,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Dhaka","1000","Bangladesh","BD",{"type":45,"coordinates":46},"Point",[47,48],90.40744,23.7104,{"lat":48,"lon":47},[51],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},{"type":53,"investigatorFullName":34,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Chairman & Professor, Department of Physical Medicine & Rehabilitation and Focal Person, Robotic Rehabilitation Centre, Bangladesh Medical University","100649539","zepu-ai1-gait-robot-training-study-zepuai1rct-100649539",false,"NCT07735676","ZEPU-AI1 Gait Robot Training Study (ZEPUAI1RCT)","Feasibility, Safety and Efficacy of ZEPU AI1 Gait Training and Evaluation System Robot in Patients With Lower Limb Motor Weakness","Inclusion Criteria:\n\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 \\>3 months post-surgery\n* Age \\>18 and ≤60 years\n* Able to provide informed consent and understand instructions\n* Weight ≤100 kg and height within device adjustable range (per manufacturer specification)\n* Medically stable and cleared by physician for exoskeleton use (no active infection, uncontrolled cardiac\u002Frespiratory disease, severe osteoporosis, uncontrolled epilepsy, or untreated DVT)\n\nExclusion Criteria:\n\n* Complete spinal cord injury with inability to bear any weight\n* Severe cognitive impairment (e.g., MMSE \\\u003C24) preventing safe participation\n* Severe spasticity (Modified Ashworth Scale \\>3) in lower limbs\n* Unstable fractures, severe hip\u002Fknee contractures (\\>30° fixed flexion), or 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":66,"type":67},32,"ESTIMATED","INTERVENTIONAL",[70],"NA","Walking problems caused by stroke, spinal cord injury, or orthopedic surgery are common and can seriously limit a person's independence. Robotic-assisted gait training devices, which use a computer-controlled system to help patients practice standing and walking, have shown promise in improving strength, balance, and walking ability in other countries. However, this type of technology has not yet been carefully studied in Bangladesh.\n\nThis study will test a robotic gait training and evaluation device called ZEPU-AI1 in adults aged 19 to 60 years who have difficulty walking due to stroke, incomplete spinal cord injury, or gait problems following surgery. The main goals are to find out whether using this robotic device alongside standard physical therapy is feasible (practical to carry out) and safe, and to explore whether it helps improve walking speed, balance, muscle strength, and daily function compared with standard physical therapy alone.\n\nThirty-two participants will take part. Half will receive robot-assisted gait training three times a week for 12 weeks in addition to usual rehabilitation therapy, while the other half will receive usual rehabilitation therapy alone. Participants will be assessed regularly using standard walking, balance, and strength tests over the 12-week period.\n\nThe results of this study will help doctors and researchers understand whether this robotic technology can be safely and effectively introduced into rehabilitation care in Bangladesh.",[73,74,75],"Stroke","Spinal Cord Injuries (SCI)","Gait Disorders, Neurologic",[77,78,79],"Gait Training","Robotic Rehabilitation","Neurorehabilitation","NOT_YET_RECRUITING","2026-07-29",{"date":83,"type":84},"2026-07-31","ACTUAL",{"date":86,"type":67},"2026-07",{"date":88,"type":67},"2026-11",{"name":5,"class":6},1]