[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650652":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":51,"studyPopulation":44,"armGroups":52,"interventions":68,"overallOfficials":91,"centralContacts":95,"locations":100,"responsibleParty":116,"collaborators":44,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":44,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":44,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":141,"overallStatus":145,"whyStopped":44,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"Bangladesh Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":44},[9,13],{"measure":10,"description":11,"timeFrame":12},"Incidence of Device-Related Adverse Events and Serious Adverse Events","Number of participants experiencing device-related adverse events (AEs) and serious adverse events (SAEs), including falls, skin breakdown\u002Fpressure sores, joint pain\u002Finjury, cardiovascular events, fracture, and device malfunction.","Baseline (T0) to 12 weeks, assessed at 2-week intervals",{"measure":14,"description":15,"timeFrame":12},"Device Tolerability","Number of training sessions completed relative to sessions planned, and number of participant drop-outs with reasons for discontinuation.",[17,20,23,26,29,32,35,38,41],{"measure":18,"description":19,"timeFrame":12},"Change in Walking Distance on 6-Minute Walk Test","Distance walked (in meters) in 6 minutes, used to assess functional exercise capacity and gait endurance.",{"measure":21,"description":22,"timeFrame":12},"Change in Muscle Strength on MRC Scale","Muscle strength of affected upper and\u002For lower limb muscle groups graded using the Medical Research Council (MRC) Muscle Strength Scale (0-5).",{"measure":24,"description":25,"timeFrame":12},"Change in Functional Ambulation Category (FAC) Score","Level of walking independence assessed using the Functional Ambulation Category, scored 0 (non-ambulatory) to 5 (independent on all surfaces).",{"measure":27,"description":28,"timeFrame":12},"Change in Balance on Berg Balance Scale-Short Form (BBS-SF)","Balance performance assessed using the Berg Balance Scale-Short Form (BBS-SF), a validated 7-item reduced version of the original 14-item Berg Balance Scale. Scores range from 0 to 28, with higher scores indicating better balance performance.",{"measure":30,"description":31,"timeFrame":12},"Change in Spasticity on Modified Ashworth Scale (MAS)","Muscle spasticity of the affected limb(s) graded using the Modified Ashworth Scale (0 to 4).",{"measure":33,"description":34,"timeFrame":12},"Change in Pain on Visual Analogue Scale (VAS)","Self-reported pain intensity rated on a 0-10 cm Visual Analogue Scale.",{"measure":36,"description":37,"timeFrame":12},"Change in Functional Independence Measure (FIM) Score","Level of independence in activities of daily living assessed using the Functional Independence Measure (FIM), an 18-item scale covering motor and cognitive domains. Total scores range from 18 to 126, with higher scores indicating greater functional independence.",{"measure":39,"description":40,"timeFrame":12},"Change in Grip Strength","Hand grip strength of the affected upper limb measured in kilograms using a hand dynamometer.",{"measure":42,"description":43,"timeFrame":12},"Change in Upper Limb Function on Action Research Arm Test (ARAT)","Upper limb motor function assessed using the Action Research Arm Test, covering grasp, grip, pinch, and gross movement subscales.",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":44,"primaryPurpose":48,"observationalModel":44,"timePerspective":44,"maskingInfo":49},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":50,"maskingDescription":44,"whoMasked":44},"NONE","Upper- and lower-limb motor dysfunction due to stroke, incomplete spinal cord injury, traumatic brain injury, and orthopedic conditions represents a major cause of long-term disability, with limited access to intensive, high-repetition rehabilitation in resource-constrained settings such as Bangladesh. Conventional physiotherapy, while effective, is often constrained by therapist workload, time limitations, and difficulty consistently delivering the volume of task-specific repetition believed necessary to drive neuroplastic recovery. Robotic rehabilitation systems offer programmable, high-repetition, objectively monitored movement training that can supplement conventional therapy, but evidence supporting their feasibility, safety, and effectiveness remains largely derived from high-income settings, with limited data from low- and middle-income countries.\n\nThis prospective, parallel-group, two-arm pilot randomized controlled trial will be conducted at the Robotic Rehabilitation Centre, Department of Physical Medicine and Rehabilitation, Bangladesh Medical University (BMU). It will evaluate four robotic rehabilitation platforms manufactured by Shandong ZEPU Medical Technology Co., Ltd: the ZEPU-AI2 (upper-extremity feedback training and evaluation system), ZEPU-AI4 (multi-joint isokinetic training and evaluation system for upper and lower limb joints), ZEPU-AI6 Plus (three-dimensional robotic upper-limb active\u002Fpassive training system), and ZEPU-AI7A (upper and lower limb active\u002Fpassive rehabilitation system using motor-driven circular motion). Each device supports active, passive, and active-assisted training modes with adjustable resistance, range of motion, and assistance level, along with integrated safety features such as emergency stop mechanisms, motion limits, and, in some systems, spasm-detection and protection functions.\n\nA total of 36 participants will be randomly allocated in a 1:1 ratio to a robotic-augmented rehabilitation arm (standard-of-care rehabilitation plus supervised robotic-assisted therapy) or a usual-care control arm (standard-of-care rehabilitation alone). The intervention phase will run for 12 weeks, with robotic sessions delivered three times weekly (approximately 45 minutes per session, including donning\u002Fdoffing and warm-up\u002Fcool-down), followed by a period of follow-up. Sessions will be supervised throughout by trained physiatrists and physiotherapists, with structured pre-session screening (vital signs, skin integrity, pain), safety harnessing during initial sessions as needed, and post-session skin and fatigue checks. Training parameters will be progressively adjusted on an individualized basis according to participant tolerance and performance.\n\nAssessments will be performed at baseline and at two-week intervals throughout the intervention and follow-up periods, using a battery of validated motor, strength, balance, gait, spasticity, pain, and functional-independence measures, together with device-recorded performance metrics (e.g., repetitions, torque, range of motion, training duration). Safety will be monitored through structured adverse event and serious adverse event reporting, with oversight from a Data Safety Monitoring Committee and a manufacturer-linked reporting pathway; predefined pause rules apply if more than two device-attributable serious adverse events occur. Feasibility and usability will be assessed through recruitment and screening metrics, session adherence and dropout rates, staff training\u002Fsetup time, and a participant usability questionnaire administered at study completion.\n\nStatistical analysis will use an intention-to-treat approach as primary, with a per-protocol analysis as secondary. Continuous efficacy variables will be summarized as mean ± SD (or median\u002FIQR where non-normally distributed) at each time point, with paired and unpaired comparisons as appropriate; a two-tailed p-value \\\u003C 0.05 will be considered statistically significant.\n\nThis pilot study is intended to generate local, context-specific evidence on the feasibility, safety, and preliminary therapeutic potential of multi-platform robotic rehabilitation in Bangladesh, to inform the design of a future, adequately powered, large-scale randomized controlled trial and to support clinical and policy decision-making around robotic rehabilitation services.",[53,63],{"label":54,"type":55,"description":56,"interventionNames":57},"Robotic-Augmented Rehabilitation (Intervention)","EXPERIMENTAL","Participants (n=18 per device cohort) receive standard-of-care physiotherapy plus robotic-assisted rehabilitation using the ZEPU-AI2, AI4, AI6 Plus, or AI7A system, 3 sessions\u002Fweek (\\~45 min each) for 12 weeks (36 sessions total), including warm-up, device donning, structured training (upper\u002Flower limb, gait, or isokinetic depending on device), and cool-down, delivered under supervision of trained physiotherapists.",[58,59,60,61,62],"Device: ZEPU-AI2","Device: ZEPU-AI4","Device: ZEPU-AI6 Plus","Device: ZEPU-AI7A","Behavioral: Standard-of-Care Physiotherapy",{"label":64,"type":65,"description":66,"interventionNames":67},"Usual Care (Control)","ACTIVE_COMPARATOR","Participants (n=18 per device cohort) receive standard-of-care rehabilitation alone (balance training, lower-limb strengthening, stretching, and gait retraining as per institutional protocol) without the addition of robotic-assisted therapy.",[62],[69,74,78,82,86],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":44},"DEVICE","ZEPU-AI2","Upper Extremity Feedback Training and Evaluation System Intervention Description: Robotic upper-extremity feedback training and evaluation device enabling active, passive, and active-assisted movement training with real-time feedback for patients with upper-limb motor dysfunction, used 3 sessions\u002Fweek for 12 weeks in addition to standard physiotherapy.",[54],{"type":70,"name":75,"description":76,"armGroupLabels":77,"otherNames":44},"ZEPU-AI4","Multi-Joint Isokinetic Training and Evaluation System Intervention Description: Robotic multi-joint isokinetic training and evaluation device supporting controlled, resistance-based rehabilitation and objective strength assessment of upper- and lower-limb joints, used 3 sessions\u002Fweek for 12 weeks in addition to standard physiotherapy.",[54],{"type":70,"name":79,"description":80,"armGroupLabels":81,"otherNames":44},"ZEPU-AI6 Plus","Multi-axis robotic arm device that simulates physiological upper-limb movement patterns for three-dimensional active and passive training, used 3 sessions\u002Fweek for 12 weeks in addition to standard physiotherapy.",[54],{"type":70,"name":83,"description":84,"armGroupLabels":85,"otherNames":44},"ZEPU-AI7A","Motor-driven robotic device providing active and passive rehabilitation of the upper and lower limbs, separately or simultaneously, via circular motion training, used 3 sessions\u002Fweek for 12 weeks in addition to standard physiotherapy.",[54],{"type":87,"name":88,"description":89,"armGroupLabels":90,"otherNames":44},"BEHAVIORAL","Standard-of-Care Physiotherapy","Conventional physiotherapy comprising balance training, lower-limb strengthening, stretching, and gait retraining delivered per institutional protocol; provided alone in the control arm and alongside robotic training in the intervention arm.",[54,64],[92],{"name":93,"affiliation":5,"role":94},"Md. Abdus Shakoor, Ph.D.","PRINCIPAL_INVESTIGATOR",[96],{"name":93,"role":97,"phone":98,"phoneExt":44,"email":99},"CONTACT","+8801819410080","shakoorma@bmu.ac.bd",[101],{"facility":5,"status":44,"city":102,"state":44,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":111,"contacts":112},"Dhaka","1000","Bangladesh","BD",{"type":107,"coordinates":108},"Point",[109,110],90.40744,23.7104,{"lat":110,"lon":109},[113],{"name":93,"role":97,"phone":114,"phoneExt":44,"email":115},"01711222912","shakoorma@bsmmu.edu.bd",{"type":94,"investigatorFullName":93,"investigatorTitle":117,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Chairman & Professor, Department of Physical Medicine & Rehabilitation and Focal Person, Robotic Rehabilitation Centre, Bangladesh Medical University","100650652","zepu-ai-series-limb-feedback-robot-training-study-zepuaisrct-100650652",false,"NCT07749625","ZEPU-AI Series Limb Feedback Robot Training Study (ZEPUAISRCT)","Feasibility, Safety and Efficacy of ZEPU-AI2, AI4, AI6 Plus and AI7A Robotic Rehabilitation Systems in Patients With Upper and Lower Limb Motor Dysfunction","Inclusion Criteria:\n\n* Presence of upper-limb motor dysfunction, with or without concurrent lower-limb impairment, due to one of the following conditions: (a) Stroke, with onset between 2 and 24 months prior to enrollment; (b) Incomplete spinal cord injury (ASIA Scale B, C, or D); (c) Traumatic brain injury; or (d) Orthopedic disorders affecting upper and\u002For lower limb motor function\n* Age between 18 and 60 years\n* Ability to understand study procedures and follow instructions, and to provide written informed consent (or assent with guardian consent where applicable)\n* Body weight and limb anthropometry compatible with ZEPU-AI2, AI4, AI6 Plus, and AI7A systems, as per manufacturer specifications\n* Medically stable and cleared by a physician for robotic rehabilitation, with no active infection, uncontrolled cardiac or respiratory disease, severe osteoporosis, uncontrolled epilepsy, or untreated deep vein thrombosis\n\nExclusion Criteria:\n\n* Complete spinal cord injury or profound motor paralysis preventing safe interaction with robotic devices\n* Severe cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score \\\u003C 24, that would compromise safe participation\n* Severe spasticity of the upper limb, defined as a Modified Ashworth Scale score \\> 3\n* Unstable fractures, severe fixed joint contractures of the shoulder, elbow, wrist, or hand (e.g., \\> 30°), or severe pain limiting safe robotic training\n* Uncontrolled cardiac arrhythmia, presence of a pacemaker, or other implanted electronic medical devices incompatible with robotic sensors\n* Pregnancy","ALL","18 Years","60 Years",{"count":129,"type":130},36,"ESTIMATED","INTERVENTIONAL",[133],"NA","The goal of this clinical trial is to learn whether robotic rehabilitation devices (ZEPU-AI2, AI4, AI6 Plus, and AI7A) are feasible, safe, and effective for adults with upper or lower limb motor problems. These problems can result from stroke, incomplete spinal cord injury, traumatic brain injury, or orthopedic surgery. The main questions it aims to answer are:\n\nIs robotic rehabilitation training safe and practical to deliver alongside conventional therapy? Does adding robotic-assisted therapy improve motor function, balance, gait, and independence in daily activities compared to conventional rehabilitation alone? What side effects or device-related problems, if any, occur during robotic training?\n\nThe Investigators will compare a robotic-augmented rehabilitation group to a control group receiving conventional rehabilitation alone, to see if adding robotic therapy leads to better recovery.\n\nParticipants will:\n\nReceive robotic-assisted therapy sessions three times a week for 12 weeks, each lasting about 45 minutes (robotic group), or continue with conventional rehabilitation alone (control group) Undergo assessments of movement, balance, walking ability, and daily function before and after the study period Be monitored for any side effects or complications related to the device or training",[136,137,138,139,140],"Stroke","Spinal Cord Injuries","Brain Injuries, Traumatic","Movement Disorder, Upper Extremity","Movement Disorder, Lower Extremity",[142,71,75,79,83,143,144],"Robotic Rehabilitation","Neurorehabilitation","Musculoskeletal Rehabilitation","NOT_YET_RECRUITING","2026-08-04",{"date":148,"type":149},"2026-08-06","ACTUAL",{"date":151,"type":130},"2026-08",{"date":153,"type":130},"2026-11",{"name":5,"class":6},1]