[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647089":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":46,"studyPopulation":39,"armGroups":47,"interventions":60,"overallOfficials":69,"centralContacts":74,"locations":79,"responsibleParty":94,"collaborators":39,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":39,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":118,"overallStatus":122,"whyStopped":39,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Bangladesh Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":39},[9,13],{"measure":10,"description":11,"timeFrame":12},"Incidence of Device-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)","Incidence of device-related adverse events (AEs) and serious adverse events (SAEs) occurring during the 12-week intervention, including falls, skin breakdown or pressure sores, joint pain or injury, cardiovascular events, fractures, and device malfunction.","Baseline through Week 12",{"measure":14,"description":15,"timeFrame":12},"Device Tolerability","Device tolerability assessed by the proportion of planned treatment sessions completed, participant adherence, study withdrawals, and reasons for withdrawal during the 12-week intervention.",[17,21,24,27,30,33,36],{"measure":18,"description":19,"timeFrame":20},"Change in 6-Minute Walk Test Distance","Change in walking endurance assessed using the 6-Minute Walk Test (6MWT)","Baseline and Week 12",{"measure":22,"description":23,"timeFrame":20},"Change in Lower-Limb Muscle Strength on the Medical Research Council (MRC) Muscle Strength Scale","Lower-limb muscle strength graded using the Medical Research Council (MRC) Muscle Strength Scale, ranging from 0 (no visible muscle contraction) to 5 (normal power against full resistance). A higher score indicates better outcome (greater muscle strength).",{"measure":25,"description":26,"timeFrame":20},"Change in Ambulatory Function on the Functional Ambulation Category (FAC)","Level of walking independence graded on the Functional Ambulation Category, ranging from 0 (non-functional ambulation, unable to walk) to 5 (independent ambulation on any surface). A higher score indicates better outcome (greater independence in walking).",{"measure":28,"description":29,"timeFrame":20},"Change in Balance on the Berg Balance Scale-Short Form (BBS-SF)","Balance and postural control assessed using the Berg Balance Scale-Short Form, a 7-item version of the original Berg Balance Scale, each item scored 0 to 4, for a total range of 0 (severely impaired balance) to 28 (excellent balance). A higher score indicates better outcome (better balance).",{"measure":31,"description":32,"timeFrame":20},"Change in Timed Up and Go (TUG) Test","Change in functional mobility assessed using the Timed Up and Go (TUG) test",{"measure":34,"description":35,"timeFrame":20},"Change in Lower-Limb Spasticity on the Modified Ashworth Scale (MAS)","Muscle tone and spasticity of the lower limbs graded on the Modified Ashworth Scale, ranging from 0 (no increase in muscle tone) to 4 (limb rigid in flexion or extension), with an intermediate grade of 1+. A lower score indicates better outcome (less spasticity).",{"measure":37,"description":38,"timeFrame":20},"Change in Health-Related Quality of Life on the EuroQol 5-Dimension (EQ-5D) Questionnaire, Validated Bengali Version","Health-related quality of life assessed using the EuroQol 5-Dimension (EQ-5D) questionnaire (validated Bengali version), comprising a descriptive index score and a visual analogue scale (EQ-VAS) ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). A higher score indicates better outcome (better quality of life).",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":45,"maskingDescription":39,"whoMasked":39},"NONE","Background:\n\nLower limb motor dysfunction is a major cause of disability following neurological and musculoskeletal disorders. Conventional rehabilitation improves function but is often limited by therapist workload and the difficulty of delivering high-intensity, repetitive, task-specific training. Robotic rehabilitation systems have the potential to overcome these limitations by providing standardized, intensive, and feedback-guided exercise.\n\nObjective:\n\nTo evaluate the safety, efficacy, and feasibility of the ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot in patients with lower limb motor dysfunction.\n\nStudy Design:\n\nThis is a prospective, single-center, pilot randomized controlled trial conducted at the Department of Physical Medicine and Rehabilitation, Bangladesh Medical University. Eligible participants will be randomly allocated in a 1:1 ratio to receive either ZEPU-AI3-assisted rehabilitation plus conventional rehabilitation or conventional rehabilitation alone.\n\nIntervention:\n\nParticipants in the intervention group will receive robot-assisted lower limb feedback training using the ZEPU-AI3 device in addition to conventional rehabilitation. The control group will receive conventional rehabilitation according to institutional standards. The intervention duration, frequency, and intensity will follow the approved study protocol.\n\nOutcome Measures:\n\nPrimary and secondary outcomes include safety, feasibility, lower limb motor recovery, gait performance, balance, functional mobility, and adverse events. Participants will be assessed at baseline and after completion of the intervention.\n\nSignificance:\n\nThis pilot study will generate preliminary evidence regarding the clinical utility, safety, and feasibility of the ZEPU-AI3 robotic rehabilitation system and will inform the design of future multicenter randomized controlled trials.",[48,55],{"label":49,"type":50,"description":51,"interventionNames":52},"ZEPU-AI3 + Conventional Rehabilitation","EXPERIMENTAL","Participants will receive ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot-assisted rehabilitation in addition to conventional rehabilitation according to the study protocol.",[53,54],"Device: ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot","Other: Conventional Rehabilitation",{"label":56,"type":57,"description":58,"interventionNames":59},"Conventional Rehabilitation","ACTIVE_COMPARATOR","Participants will receive conventional rehabilitation according to institutional standard care without ZEPU-AI3 robotic training.",[54],[61,66],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":39},"DEVICE","ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot","Participants assigned to the experimental arm will receive rehabilitation using the ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot in addition to conventional rehabilitation. Robot-assisted training will be delivered according to the approved study protocol, including supervised lower-limb feedback training sessions combined with standard rehabilitation care.",[49],{"type":6,"name":56,"description":67,"armGroupLabels":68,"otherNames":39},"Participants assigned to the control arm will receive conventional rehabilitation according to the standard clinical practice of the Department of Physical Medicine and Rehabilitation, Bangladesh Medical University. Conventional rehabilitation may include therapeutic exercises, gait training, balance training, strengthening exercises, and other standard rehabilitation interventions as indicated.",[56,49],[70],{"name":71,"affiliation":72,"role":73},"Md. Abdus Shakoor, Ph.D.","Department of Physical Medicine & Rehabilitation, Bangladesh Medical University, Dhaka, Bangladesh","PRINCIPAL_INVESTIGATOR",[75],{"name":71,"role":76,"phone":77,"phoneExt":39,"email":78},"CONTACT","+8801819410080","shakoorma@bmu.ac.bd",[80],{"facility":5,"status":39,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Dhaka","Dhaka Division","1000","Bangladesh","BD",{"type":87,"coordinates":88},"Point",[89,90],90.40744,23.7104,{"lat":90,"lon":89},[93],{"name":71,"role":76,"phone":77,"phoneExt":39,"email":78},{"type":73,"investigatorFullName":71,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"Chairman & Professor, Department of Physical Medicine & Rehabilitation, Bangladesh Medical University","100647089","zepu-ai3-lower-limb-feedback-robot-training-study-100647089",false,"NCT07705906","ZEPU-AI3 Lower Limb Feedback Robot Training Study","Safety, Efficacy and Feasibility of ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot","ZEPUAI3RCT","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 \\> 3month post-surgery. Stroke onset between 2-24 months ensures inclusion of individuals in the subacute to chronic phase, where gait recovery is still achievable and measurable. Incomplete SCI targets individuals with partial motor preservation, who are capable of engaging in active gait training with robotic assistance.\n\n  * Age \\>18 and ≤ 60 years. This age limit is chosen because individuals with this age range generally have better cardiopulmonary reserve and musculoskeletal tolerance, allowing safer participation in intensive robotic-assisted training with reduced risk of adverse events. Excluding younger patients minimizes heterogeneity related to growth, neurodevelopmental factors and congenital disorders, which may influence gait mechanics and response to robotic therapy. Excluding older adults (\\>60 years) helps reduce confounding from age-related degenerative changes that may affect gait outcomes and safety.\n  * Able to provide informed consent and understand instructions which ensures participants can actively engage in therapy, follow safety instructions and report adverse events.\n  * Weight ≤ 100 kg (as per device spec) and height within device adjustable range (manufacturer spec). Exceeding weight or height limits may compromise mechanical support, safety, and accurate gait training.\n  * Medically stable and cleared by physician for exoskeleton use (no active infection, uncontrolled cardiac\u002Frespiratory disease, severe osteoporosis, uncontrolled epilepsy, untreated DVT) through pre-screening with necessary investigations.\n\nExclusion Criteria:\n\n* • Complete spinal cord injury with inability to bear any weight as it requires the patient to actively support some body weight or participate in stepping movements.\n\n  * Severe cognitive impairment (e.g., MMSE \\\u003C 24) preventing safe participation.\n  * Severe spasticity (Modified Ashworth Scale \\> 3) in lower limbs. High muscle tone or rigidity increases risk of joint strain, skin injury and falls during robotic-assisted training.\n  * Unstable fractures, severe hip\u002Fknee contractures (\\> 30° fixed flexion), severe osteoarthritis requiring imminent surgery. They can pose high risk for injury during weight-bearing or gait cycles.\n  * Uncontrolled cardiac arrhythmia, pacemaker incompatibility or implanted electronic device incompatible with robot sensors. Individuals with these conditions may face elevated risk of adverse cardiac events or device malfunction.\n  * Pregnancy as safety data for robotic exoskeleton use in pregnant individuals are lacking.","ALL","18 Years","70 Years",{"count":108,"type":109},32,"ESTIMATED","INTERVENTIONAL",[112],"NA","Lower limb motor dysfunction resulting from stroke, spinal cord injury, or other neurological disorders substantially limits mobility, independence, and quality of life. Robotic rehabilitation has emerged as a promising approach to provide intensive, repetitive, task-oriented training. The ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot is designed to deliver interactive lower limb training while providing real-time performance feedback. This pilot randomized controlled trial aims to evaluate the safety, efficacy, and feasibility of ZEPU-AI3-assisted rehabilitation combined with conventional rehabilitation compared with conventional rehabilitation alone in patients with lower limb motor dysfunction. The primary outcomes include safety, feasibility, and changes in lower limb motor function, gait performance, and functional mobility. The findings will provide preliminary evidence to support future large-scale clinical trials and the implementation of robotic rehabilitation in clinical practice.",[115,116,117],"Stroke","Spinal Cord Injuries","Gait Disorders",[119,120,121],"Robotic Rehabilitation","Neurorehabilitation","Feedback Training","NOT_YET_RECRUITING","2026-07-26",{"date":125,"type":126},"2026-07-28","ACTUAL",{"date":128,"type":109},"2026-07-15",{"date":130,"type":109},"2026-11-15",{"name":5,"class":6},1]