[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649539":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":43,"studyPopulation":36,"armGroups":44,"interventions":57,"overallOfficials":36,"centralContacts":68,"locations":74,"responsibleParty":88,"collaborators":36,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":36,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":36,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":112,"overallStatus":116,"whyStopped":36,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"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 and Serious Adverse Events","Number and proportion of participants experiencing device-related adverse events (AEs) and serious adverse events (SAEs), including falls, skin breakdown\u002Fpressure sores, joint pain\u002Finjury, cardiovascular events, and fracture, during the intervention and follow-up period.","Baseline (T=0) through 12-week intervention period and follow-up, assessed every 2 weeks",[14,18,21,24,27,30,33],{"measure":15,"description":16,"timeFrame":17},"Change in Six-Minute Walk Distance (6MWD)","Distance (in meters) walked in six minutes, a standardized measure of walking capacity, endurance, and functional mobility.","Baseline (T=0), every 2 weeks through 12 weeks",{"measure":19,"description":20,"timeFrame":17},"Change in Medical Research Council (MRC) Muscle Strength Scale","Manual muscle strength grading of lower-limb muscle groups using the Medical Research Council (MRC) Muscle Strength Scale, scored from 0 (no muscle contraction) to 5 (normal muscle strength), with higher scores indicating better muscle strength.",{"measure":22,"description":23,"timeFrame":17},"Change in Functional Ambulation Category (FAC) Score","Level of physical assistance required for ambulation assessed using the Functional Ambulation Category, a 6-point 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.",{"measure":25,"description":26,"timeFrame":17},"Change in Berg Balance Scale Score","Assessment of static and dynamic balance during functional tasks using the Berg Balance Scale, a clinician-administered scale ranging from 0 to 56, with higher scores indicating better balance.",{"measure":28,"description":29,"timeFrame":17},"Change in Timed Up and Go (TUG) Test","Time (in seconds) taken to rise from a chair, walk 3 meters, turn, walk back, and sit down; a measure of functional mobility and fall risk.",{"measure":31,"description":32,"timeFrame":17},"Change in Modified Ashworth Scale (MAS) for Lower-Limb Muscles","Clinical assessment of spasticity\u002Fmuscle tone in the lower limbs using the Modified Ashworth Scale (MAS), scored from 0 (no increase in muscle tone) to 4 (limb rigid in flexion or extension), with higher scores indicating greater spasticity (worse outcome).",{"measure":34,"description":35,"timeFrame":17},"Change in Quality of Life (EuroQol Questionnaire, Bengali Version)","Validated Bengali-language EuroQol (EQ-5D) questionnaire assessing health-related quality of life, a self-rated measure with a descriptive system score and index value where higher scores\u002Fvalues indicate better health-related quality of life.",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","This is a single-site, pilot, randomized controlled trial evaluating the feasibility, safety, and preliminary efficacy of the ZEPU-AI1 Gait Training and Evaluation System, a computer-controlled robotic rehabilitation device, in adults with lower-limb motor dysfunction. The trial will be conducted at the Robotic Rehabilitation Centre, Department of Physical Medicine and Rehabilitation, Bangladesh Medical University (BMU), Dhaka, Bangladesh.\n\nThirty-two participants aged 19-60 years with lower-limb motor dysfunction secondary to stroke (2-24 months post-onset), incomplete spinal cord injury (ASIA C or D, neurological level T12 or below), or persistent gait impairment following orthopedic surgery (\\>3 months post-surgery) will be enrolled after screening against detailed inclusion\u002Fexclusion criteria (including device-specific anthropometric limits, medical stability, and absence of severe spasticity, unstable fractures, or cardiac contraindications). Participants will be randomized into two parallel arms:\n\nIntervention Arm (n=16): ZEPU-AI1 robot-assisted gait training combined with standard-of-care rehabilitation.\n\nControl Arm (n=16): Standard-of-care rehabilitation alone.\n\nThe ZEPU-AI1 is a bilateral robotic exoskeleton system integrating a gait control unit (programmable hip range 30°-50°, knee range 50°-80°), a dynamic body-weight support mechanism (0-80 kg unloading), a motorized treadmill (0.1-3.5 km\u002Fh), and dedicated software providing real-time gait monitoring, spasticity detection, and automatic safety shutoff. Intervention-arm participants will undergo supervised training three times weekly for 12 weeks (36 sessions total), each session approximately 45 minutes, comprising warm-up, device donning, structured standing\u002Fgait training (sit-to-stand, in-place stepping, overground walking, turning), and cool-down, with progressive adjustment of speed, body-weight support, and duration based on tolerance.\n\nPrimary outcomes are feasibility (recruitment, session adherence, device set-up\u002Fdonning time, therapist competency time) and safety (incidence of device-related adverse events and serious adverse events, tolerability, dropout rate), assessed continuously throughout the intervention and at two-week intervals.\n\nSecondary outcomes assess efficacy using standardized, validated instruments administered at baseline and two-week intervals over the 12-week period: 6-Minute Walk Test, Medical Research Council (MRC) Muscle Strength Scale, Functional Ambulation Category (FAC), Berg Balance Scale, Timed Up and Go (TUG) test, Modified Ashworth Scale (MAS), and a validated Bengali version of the EuroQol quality-of-life questionnaire. Usability and acceptability will be assessed via the Post-Study System Usability Questionnaire (PSSUQ) at study completion.\n\nData will be collected on standardized case report forms and entered into a password-protected, anonymized electronic database, with independent verification and monthly adverse-event review by a safety monitor not involved in training delivery. Analysis will follow an intention-to-treat approach (with a secondary per-protocol analysis), using descriptive statistics for safety\u002Ffeasibility outcomes and paired\u002Funpaired t-tests or Wilcoxon signed-rank tests (as appropriate for data distribution) to compare baseline versus follow-up efficacy outcomes, with statistical significance set at p\\\u003C0.05 (two-tailed).\n\nThis pilot study is intended to generate foundational safety, feasibility, and effect-size data to inform the design of a future, adequately powered randomized controlled trial and to guide responsible implementation of robotic gait rehabilitation technology within the Bangladeshi healthcare context.",[45,52],{"label":46,"type":47,"description":48,"interventionNames":49},"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.",[50,51],"Device: ZEPU-AI1 Gait Training and Evaluation System","Behavioral: Standard-of-Care Rehabilitation (Individualized Rehabilitation and Exercise)",{"label":53,"type":54,"description":55,"interventionNames":56},"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.",[51],[58,63],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":36},"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",[46],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":36},"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.",[46,53],[69],{"name":70,"role":71,"phone":72,"phoneExt":36,"email":73},"Md. Abdus Shakoor, Ph.D.","CONTACT","+8801819410080","shakoorma@bmu.ac.bd",[75],{"facility":5,"status":36,"city":76,"state":36,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Dhaka","1000","Bangladesh","BD",{"type":81,"coordinates":82},"Point",[83,84],90.40744,23.7104,{"lat":84,"lon":83},[87],{"name":70,"role":71,"phone":72,"phoneExt":36,"email":73},{"type":89,"investigatorFullName":70,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"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":102,"type":103},32,"ESTIMATED","INTERVENTIONAL",[106],"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.",[109,110,111],"Stroke","Spinal Cord Injuries (SCI)","Gait Disorders, Neurologic",[113,114,115],"Gait Training","Robotic Rehabilitation","Neurorehabilitation","NOT_YET_RECRUITING","2026-07-29",{"date":119,"type":120},"2026-07-31","ACTUAL",{"date":122,"type":103},"2026-07",{"date":124,"type":103},"2026-11",{"name":5,"class":6},1]