[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649645":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":43,"studyPopulation":36,"armGroups":44,"interventions":57,"overallOfficials":68,"centralContacts":72,"locations":78,"responsibleParty":92,"collaborators":36,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":36,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":36,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":119,"whyStopped":36,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Bangladesh Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Device-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)","Number and proportion of participants experiencing device-related adverse events, including falls, skin breakdown\u002Fpressure sores, joint pain\u002Finjury, cardiovascular events, fracture, and device malfunction, recorded through continuous monitoring during each robotic training session and reviewed monthly by an independent safety monitor.","From baseline (T=0) through 12-week intervention and follow-up (T=12 weeks)",[14,18,21,24,27,30,33],{"measure":15,"description":16,"timeFrame":17},"Change in Walking Distance (6-Minute Walk Test)","Distance walked in 6 minutes, measured using the standardized 6-Minute Walk Test to assess functional exercise capacity and gait endurance, compared between the ZEPU-AI5 intervention group and control group.","Baseline and every 2 weeks up to Week 12",{"measure":19,"description":20,"timeFrame":17},"Change in Lower-Limb Muscle Strength (MRC Scale)","Lower-limb muscle strength assessed using the Medical Research Council (MRC) Muscle Strength Scale (0-5 grading), compared between the ZEPU-AI5 intervention group and control group.",{"measure":22,"description":23,"timeFrame":17},"Change in Functional Ambulation Category (FAC) Score","Level of ambulatory function and physical assistance required for walking, assessed using the Functional Ambulation Category, a clinician-rated ordinal scale ranging from 0 (non-functional ambulation, unable to walk) to 5 (independent ambulation on any surface), with higher scores indicating better ambulatory function, compared between the ZEPU-AI5 intervention group and control group.",{"measure":25,"description":26,"timeFrame":17},"Change in Balance (Berg Balance Scale-Short Form)","Balance and postural control assessed using the Berg Balance Scale-Short Form (BBS-SF), a clinician-administered scale ranging from 0 to 28, with higher scores indicating better balance, compared between the ZEPU-AI5 intervention group and control group.",{"measure":28,"description":29,"timeFrame":17},"Change in Functional Mobility (Timed Up and Go Test)","Functional mobility and fall risk assessed using the Timed Up and Go (TUG) test, measuring time taken to rise from a chair, walk a short distance, turn, and sit back down, compared between groups.",{"measure":31,"description":32,"timeFrame":17},"Change in Lower-Limb Spasticity (Modified Ashworth Scale)","Muscle tone and spasticity of the lower limbs assessed using the Modified Ashworth Scale (MAS), a clinician-rated measure of resistance to passive muscle stretch, scored from 0 (no increase in muscle tone) to 4 (limb rigid in flexion or extension), with higher scores indicating greater spasticity (worse outcome), compared between the ZEPU-AI5 intervention group and control group.",{"measure":34,"description":35,"timeFrame":17},"Change in Health-Related Quality of Life (EuroQol Questionnaire)","Health-related quality of life assessed using the EuroQol 5-Dimension (EQ-5D) questionnaire, validated Bengali version, a self-rated measure with a descriptive system score and index value where higher scores\u002Fvalues indicate better health-related quality of life, compared between the ZEPU-AI5 intervention group and control group.",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":36,"whoMasked":36},"NONE","Walking impairment due to neurological and orthopedic conditions significantly limits independence and functional mobility, making lower-limb strength training a key focus of rehabilitation. Robotic-assisted rehabilitation systems have shown promising results in improving strength and functional outcomes in high-income countries; however, their feasibility, safety, and efficacy remain underexplored in low- and middle-income settings. In Bangladesh, the ZEPU-AI5 lower-limb strength training and evaluation robot is a novel technology that has not yet been systematically evaluated in this population.\n\nThe ZEPU-AI5 is a computer-controlled electromechanical rehabilitation device consisting of a rigid main frame, a motor-driven walking training table, bilateral robotic mechanical legs aligned with the patient's hip and knee joints, adjustable foot pedals, thigh and calf fixation straps, and a body-weight support suspension system. The walking platform supports up to 135 kg, with continuously adjustable body-weight unloading from 0-80 kg, allowing progressive loading according to patient tolerance and recovery stage. Prior to training, individualized calibration is performed by measuring thigh and calf lengths to align the robotic joints with the participant's anatomical hip and knee axes, with bilateral symmetry adjustment available when needed.\n\nThe system provides programmable control over hip joint angles (30°-50°) and knee joint angles (50°-80°) in 1° increments, with gait offset parameters adjustable by ±10 units to allow individualized correction of abnormal gait patterns. Walking speed is adjustable from 0.1 to 3.5 km\u002Fh, allowing graded progression from slow assisted stepping to higher-speed gait training.\n\nAt study entry, participants will undergo a face-to-face interview to gather clinical and sociodemographic data using a semi-structured, pre-tested questionnaire. Weight and height will be measured to calculate Body Mass Index (BMI). All participants will be allocated a study ID, and assessments will be conducted at the Robotic Rehabilitation Center, Department of Physical Medicine and Rehabilitation, Bangladesh Medical University.",[45,52],{"label":46,"type":47,"description":48,"interventionNames":49},"Intervention Arm (Robotic-Augmented Rehabilitation Group)","EXPERIMENTAL","18 participants receiving standard-of-care rehabilitation combined with ZEPU-AI5 assisted gait training",[50,51],"Device: Robotic lower-limb gait training (ZEPU-AI5)","Behavioral: Standard-of-care rehabilitation (conventional physiotherapy)",{"label":53,"type":54,"description":55,"interventionNames":56},"Control Arm (Usual Care Group)","ACTIVE_COMPARATOR","18 participants receiving standard-of-care rehabilitation alone (including IRR and exercise)",[51],[58,63],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":36},"DEVICE","Robotic lower-limb gait training (ZEPU-AI5)","The ZEPU-AI5 Lower Limb Strength Training and Evaluation Robot (Shandong ZEPU Medical Technology Co. Ltd.) is a computer-controlled electromechanical rehabilitation device that delivers task-specific, repetitive lower-limb gait training. It consists of a motorized walking platform, bilateral robotic mechanical legs aligned to the patient's hip and knee joints, adjustable body-weight support (0-80 kg unloading, up to 135 kg capacity), and an overhead safety harness. Hip joint range is adjustable 30-50° and knee joint range 50-80°, with walking speed adjustable from 0.1-3.5 km\u002Fh. Training modes include standing, sitting, stepping-in-place, and over-ground walking. Participants in the intervention arm will receive robot-assisted gait training 3 sessions\u002Fweek for 12 weeks (45 minutes\u002Fsession, \\~36 sessions total), supervised by trained physiotherapists, in addition to standard-of-care rehabilitation. Real-time feedback on joint angles, torque, and gait parameters is provided, with built-in",[46],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":36},"BEHAVIORAL","Standard-of-care rehabilitation (conventional physiotherapy)","Standard-of-care rehabilitation consisting of conventional physiotherapy, including individualized rehabilitation regimen (IRR) and exercise therapy, delivered by trained physiotherapists at the Department of Physical Medicine and Rehabilitation, Bangladesh Medical University. This includes balance training, lower-limb strengthening exercises, stretching, and gait retraining, following standard institutional rehabilitation protocols. Participants in the control arm receive this standard therapy alone, without robotic-assisted gait training, over the same 12-week study period, with outcome assessments conducted at baseline and two-week intervals.",[53,46],[69],{"name":70,"affiliation":5,"role":71},"Md. Abdus A Shakoor, Ph.D.","PRINCIPAL_INVESTIGATOR",[73],{"name":74,"role":75,"phone":76,"phoneExt":36,"email":77},"Md. Abdus Shakoor, Ph.D.","CONTACT","+8801819410080","shakoorma@bmu.ac.bd",[79],{"facility":5,"status":36,"city":80,"state":36,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Dhaka","1000","Bangladesh","BD",{"type":85,"coordinates":86},"Point",[87,88],90.40744,23.7104,{"lat":88,"lon":87},[91],{"name":74,"role":75,"phone":76,"phoneExt":36,"email":77},{"type":71,"investigatorFullName":74,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Chairman & Professor, Department of Physical Medicine & Rehabilitation and Focal Person, Robotic Rehabilitation Centre, Bangladesh Medical University","100649645","zepu-ai5-strength-training-study-zepuai5rct-100649645",false,"NCT07735702","ZEPU-AI5 Strength Training Study (ZEPUAI5RCT)","Safety, Feasibility and Efficacy of ZEPU AI5 Lower Limb Muscle Strength Training and Evaluation Robot","Inclusion Criteria:\n\n* Lower-limb motor dysfunction due to one of the following: (a) stroke (onset 2-24 months), (b) incomplete spinal cord injury (neurological level T12 or below, ASIA Impairment Scale C or D), or (c) orthopedic surgery (e.g., knee\u002Fhip replacement) with persistent gait impairment more than 3 months post-surgery\n* Age greater than 18 years and up to 60 years\n* Medically stable and able to provide informed consent\n* Able to meet device anthropometric criteria for use of the ZEPU-AI5 system\n\nExclusion Criteria:\n\n* Complete spinal cord injury with inability to bear any weight\n* Severe cognitive impairment (Mini-Mental State Examination score less than 24) preventing safe participation\n* Severe spasticity of the lower limbs (Modified Ashworth Scale greater than 3)\n* Unstable fractures, severe hip\u002Fknee contractures (greater than 30 degrees fixed flexion), or severe osteoarthritis requiring imminent surgery\n* Uncontrolled cardiac arrhythmia, pacemaker incompatibility, or any implanted electronic device incompatible with the robot's sensors\n* Pregnancy","ALL","18 Years","60 Years",{"count":105,"type":106},36,"ESTIMATED","INTERVENTIONAL",[109],"NA","The goal of this clinical trial is to learn if robot-assisted lower-limb strength and gait training can improve safety, feasibility, and functional recovery in adults aged 18-60 years with lower-limb motor dysfunction due to stroke, incomplete spinal cord injury, or persistent gait impairment following orthopedic surgery. The main questions it aims to answer are:\n\nIs robot-assisted training using the ZEPU-AI5 device safe and well-tolerated, with an acceptable rate of device-related adverse events? Does adding ZEPU-AI5-assisted training to standard-of-care rehabilitation improve functional outcomes (such as walking distance, muscle strength, balance, and mobility) compared to standard-of-care rehabilitation alone?\n\nResearchers will compare an intervention group receiving standard-of-care rehabilitation combined with ZEPU-AI5-assisted training to a control group receiving standard-of-care rehabilitation alone, to see if the addition of robotic training leads to greater improvements in safety, functional recovery, and quality of life.\n\nParticipants will:\n\nUndergo a baseline assessment before starting the study Receive either robot-assisted training plus standard-of-care rehabilitation, or standard-of-care rehabilitation alone, three times per week for 12 weeks Complete follow-up assessments every two weeks to evaluate safety, functional outcomes, and durability of any benefits",[112,113,114],"Stroke","Incomplete Spinal Cord Injury","Gait Impairment Following Orthopedic Surgery",[116,117,118],"Robotic Rehabilitation","Neurorehabilitation","Muscle Strength","NOT_YET_RECRUITING","2026-07-29",{"date":122,"type":123},"2026-07-31","ACTUAL",{"date":125,"type":106},"2026-07",{"date":127,"type":106},"2026-11",{"name":5,"class":6},1]