[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650564":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":46,"studyPopulation":39,"armGroups":47,"interventions":62,"overallOfficials":81,"centralContacts":85,"locations":90,"responsibleParty":105,"collaborators":39,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":39,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":39,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":130,"overallStatus":135,"whyStopped":39,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"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 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 or injury, cardiovascular events, fracture, and device malfunction.","Baseline (T=0) up to 12 weeks, assessed every 2 weeks",{"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.",[17,21,24,27,30,33,36],{"measure":18,"description":19,"timeFrame":20},"Change in Muscle Strength","Muscle strength assessed using the unabbreviated Medical Research Council (MRC) Muscle Scale, ranging from 0 (no visible or palpable contraction) to 5 (normal strength), with higher scores indicating better muscle strength.","Baseline (T=0) to 12 weeks, assessed every 2 weeks",{"measure":22,"description":23,"timeFrame":20},"Change in Muscle Spasticity","Muscle spasticity assessed using the unabbreviated Modified Ashworth Scale (MAS), ranging from 0 (no increase in muscle tone) to 4 (limb rigid in flexion or extension), with higher scores indicating worse (greater) spasticity.",{"measure":25,"description":26,"timeFrame":20},"Change in Functional Ambulation","Walking ability assessed using the unabbreviated Functional Ambulation Category (FAC) scale, ranging from 0 (unable to walk or requires help from two or more persons) to 5 (able to walk independently on level and uneven ground, stairs, and slopes), with higher scores indicating better functional ambulation.",{"measure":28,"description":29,"timeFrame":20},"Change in Functional Independence","Functional independence assessed using the Functional Independence Measure (FIM).",{"measure":31,"description":32,"timeFrame":20},"Change in Functional Mobility","Functional mobility and fall risk assessed using the Timed Up and Go Test (TUG).",{"measure":34,"description":35,"timeFrame":20},"Change in Upper Limb Motor Function","Upper limb motor function assessed using the Action Research Arm Test (ARAT).",{"measure":37,"description":38,"timeFrame":20},"Change in Activities of Daily Living","Independence in activities of daily living assessed using the Barthel Index.",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","This is a pilot randomized controlled trial evaluating the feasibility, safety, and preliminary efficacy of three robotic upper and lower limb rehabilitation trainer systems - ZEPU-2000A (upper limb trainer), ZEPU-2000D (lower limb gait and mobility trainer), and ZEPU-2000E (multifunctional upper and lower limb trainer) - when added to conventional rehabilitation, compared with conventional rehabilitation alone, in adults with upper and\u002For lower limb motor dysfunction.\n\nRationale: Upper- and lower-limb motor dysfunction following stroke, incomplete spinal cord injury, traumatic brain injury, and orthopedic conditions is a major cause of long-term disability. Motor recovery is closely linked to repetitive, task-specific, goal-oriented movement practice, but conventional therapist-led rehabilitation is often limited by therapist availability, fatigue, and variability in delivery. Electromechanical and robotic trainer systems can deliver standardized, repetitive, programmable movement training with objective performance monitoring across passive, active-assisted, and active-resisted modes. While robotic rehabilitation has shown benefit in high-income settings, evidence on feasibility, safety, and effectiveness in low- and middle-income countries remains limited. This study will generate local evidence to support the integration of the ZEPU-2000 series into rehabilitation services at Bangladesh Medical University (BMU) and to inform the design of a future adequately powered trial.\n\nSetting: Robotic Rehabilitation Centre, Department of Physical Medicine and Rehabilitation, Bangladesh Medical University, Dhaka, Bangladesh. Devices are provided and supported by the manufacturer (Shandong ZEPU Medical Technology Co. Ltd) through an approved distributor. Sessions are conducted under the supervision of physiatrists and physiotherapists.\n\nDesign: Thirty-six participants will be enrolled for each robotic system and randomized 1:1 into two arms:\n\nIntervention arm (Robotic-Augmented Rehabilitation Group): standard-of-care rehabilitation plus robotic-assisted therapy using the ZEPU-2000A, ZEPU-2000D, or ZEPU-2000E systems.\n\nControl arm (Usual Care Group): standard-of-care rehabilitation alone (individualized rehabilitation and exercise), without robotic training.\n\nAll participants undergo baseline assessment at week 0, with outcome assessments repeated at two-week intervals across the 12-week intervention period and during follow-up.\n\nPopulation: Adults aged 18-60 years with upper-limb motor dysfunction (with or without lower-limb involvement) due to stroke (2-24 months post-onset), incomplete spinal cord injury (ASIA Impairment Scale C or D, neurological level C5 or below), traumatic brain injury with persistent upper-limb limitation, or orthopedic\u002Fpost-surgical conditions of the shoulder, elbow, wrist, or hand with functional impairment lasting more than 3 months. Participants must be medically stable, able to provide informed consent, and have body size\u002Fanthropometry compatible with the devices. Exclusions include complete spinal cord injury, severe cognitive impairment (MMSE \\\u003C 24), severe upper-limb spasticity (Modified Ashworth Scale \\> 3), unstable fractures or severe fixed joint contractures, uncontrolled cardiac arrhythmia or incompatible implanted electronic devices, and pregnancy.\n\nIntervention: Robotic training sessions occur 3 times weekly for 12 weeks (approximately 36 sessions total), each lasting about 45 minutes inclusive of donning\u002Fdoffing and warm-up\u002Fcool-down. A typical session includes a 5-minute warm-up, 10 minutes of device set-up, 25 minutes of structured training (e.g., sit-to-stand, standing, in-place and over-ground walking, turning, or upper-limb task-oriented movement depending on device), and a 5-minute cool-down. Training parameters (e.g., support level, range, speed) are progressively adjusted weekly by the supervising physiotherapist based on participant performance and safety. Standard physical therapy continues per institutional protocol in both arms. Pre-session checks include vital signs, skin integrity, and pain\u002Fdiscomfort screening; safety harnesses are used during early sessions until safe performance is demonstrated; a therapist is present throughout; and post-session checks include skin inspection, fatigue\u002Fpain rating (VAS), and review of device-logged training data.\n\nOutcome Measures:\n\nPrimary (safety\u002Ffeasibility): incidence of device-related adverse events (AEs) and serious adverse events (SAEs) - including falls, skin breakdown, joint pain\u002Finjury, cardiovascular events, fracture, or device malfunction - over the 12-week intervention and follow-up; device tolerability (sessions completed vs. planned, dropouts and reasons).\n\nSecondary (efficacy): Medical Research Council (MRC) muscle strength grading, Modified Ashworth Scale (MAS) for spasticity, Functional Ambulation Category (FAC), Functional Independence Measure (FIM), Timed Up and Go (TUG), Action Research Arm Test (ARAT), and Barthel Index.\n\nFeasibility\u002Fusability: screening and recruitment metrics, session adherence, time required for therapist competency training, device set-up time, assistance required for donning\u002Fdoffing, and the Post-Study System Usability Questionnaire (PSSUQ) administered at week 16 to assess device comfort, perceived benefit, and willingness to continue.\n\nData Collection: Clinical and sociodemographic data are collected at enrolment via a semi-structured, pre-tested questionnaire. Height and weight are measured to calculate BMI. Assessments are repeated at baseline and two-week intervals for 12 weeks. Telephone and video calls supplement in-person visits to monitor compliance; robotic sessions are tracked via attendance sheets.\n\nStatistical Analysis: Descriptive statistics will summarize safety outcomes (AE\u002FSAE counts, adherence, dropouts). Continuous efficacy variables will be summarized as mean ± SD (or median\u002FIQR if non-normally distributed) at each time point, with paired and unpaired t-tests or Wilcoxon signed-rank tests used to compare baseline versus follow-up findings, as appropriate. Both intention-to-treat (all 36 randomized participants, 18 per group) and per-protocol analyses (participants completing the intervention as specified) will be conducted. Missing follow-up data will be handled using group-wise mean substitution. Statistical significance will be set at p \\\u003C 0.05 (two-tailed), using SPSS.\n\nSafety Monitoring: Identified risks include falls, joint stress or injury, skin breakdown from device straps, cardiovascular events, equipment malfunction, fatigue, muscle soreness, and spasticity exacerbation. Mitigation measures include safety harnesses, continuous physiotherapist\u002Fphysician presence, pre-session vital sign screening, gradual progression of training intensity, skin inspections, an emergency stop mechanism, staff training on emergency procedures, and immediate AE reporting. SAEs will be reported to the BMU Institutional Review Board within 24 hours and to the manufacturer per their protocol. A Data Safety Monitoring Committee (including representatives from Neuromedicine, Physical Medicine and Rehabilitation, and Internal Medicine) will conduct monthly safety reviews, with a pre-specified pause rule if more than 2 device-attributable SAEs occur. Any study-related physical injury will be managed free of cost to the participant.\n\nEthics: The protocol and informed consent form have been reviewed and approved by the BMU Institutional Review Board (Memo No. BMU\u002F2026\u002F5035, dated 13-05-2026) prior to enrolment. Written informed consent will be obtained in Bengali (with an English version available), covering device use, potential risks and benefits, voluntary participation, and the right to withdraw at any time without affecting standard care. Participant confidentiality will be maintained, and the study will be registered on a public trial registry before first participant enrolment.",[48,57],{"label":49,"type":50,"description":51,"interventionNames":52},"Robotic-Augmented Rehabilitation Group","EXPERIMENTAL","Participants receive standard-of-care rehabilitation combined with robotic-assisted therapy using the ZEPU-2000A, ZEPU-2000D, or ZEPU-2000E upper and lower limb trainer systems. Robotic training is provided 3 times weekly for 12 weeks (approximately 36 sessions), each session lasting approximately 45 minutes and including warm-up, device set-up, structured passive\u002Factive-assisted\u002Factive training, and cool-down.",[53,54,55,56],"Device: ZEPU-2000A","Device: ZEPU-2000D","Device: ZEPU-2000E","Behavioral: Standard Rehabilitation Care",{"label":58,"type":59,"description":60,"interventionNames":61},"Usual Care Group","ACTIVE_COMPARATOR","Participants receive standard-of-care rehabilitation alone, including individualized rehabilitation and exercise (e.g., strengthening, balance training, stretching, gait retraining), without robotic-assisted therapy.",[56],[63,68,72,76],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":39},"DEVICE","ZEPU-2000A","An electromechanical upper limb rehabilitation system providing passive, active-assisted, and active-resisted movement training across the shoulder, elbow, and wrist. Integrated sensors record range of motion, movement speed, and torque, with software-guided protocols and real-time feedback. Administered 3 times weekly for 12 weeks in addition to standard rehabilitation.",[49],{"type":64,"name":69,"description":70,"armGroupLabels":71,"otherNames":39},"ZEPU-2000D","A lower limb robotic trainer with actuated joints at the hip, knee, and ankle supporting repetitive stepping and weight-bearing training that simulates gait kinematics. Provides passive to active-assisted progression with force sensors and visual biofeedback on step length, cadence, and symmetry. Administered 3 times weekly for 12 weeks in addition to standard rehabilitation.",[49],{"type":64,"name":73,"description":74,"armGroupLabels":75,"otherNames":39},"ZEPU-2000E","A multifunctional robotic system combining upper and lower limb training on a single platform, supporting task-oriented movements such as reaching-to-grasp, stepping, and sit-to-stand. Intelligent control adjusts support level in real time based on performance. Administered 3 times weekly for 12 weeks in addition to standard rehabilitation.",[49],{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":39},"BEHAVIORAL","Standard Rehabilitation Care","Individualized conventional rehabilitation without robotic assistance, including therapist-led strengthening exercises, balance training, stretching, and gait retraining, delivered per institutional protocol throughout the 12-week study period.",[49,58],[82],{"name":83,"affiliation":5,"role":84},"Md. Abdus Shakoor, Ph.D.","PRINCIPAL_INVESTIGATOR",[86],{"name":83,"role":87,"phone":88,"phoneExt":39,"email":89},"CONTACT","+8801819410080","shakoorma@bmu.ac.bd",[91],{"facility":5,"status":39,"city":92,"state":39,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"Dhaka","1000","Bangladesh","BD",{"type":97,"coordinates":98},"Point",[99,100],90.40744,23.7104,{"lat":100,"lon":99},[103],{"name":83,"role":87,"phone":88,"phoneExt":39,"email":104},"shakoorma@bsmmu.edu.bd",{"type":84,"investigatorFullName":83,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"Chairman & Professor, Department of Physical Medicine & Rehabilitation and Focal Person, Robotic Rehabilitation Centre, Bangladesh Medical University","100650564","zepu-2000-limb-rehabilitation-trainer-study-zepu2000rct-100650564",false,"NCT07749612","ZEPU-2000 Limb Rehabilitation Trainer Study (ZEPU2000RCT)","Feasibility, Safety and Efficacy of ZEPU-2000A, ZEPU-2000D and ZEPU-2000E Upper and Lower Limb Active and Passive Rehabilitation Trainer 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: stroke with onset between 2 and 24 months prior to enrolment; incomplete spinal cord injury (neurological level C5 and below), classified as ASIA Impairment Scale C or D; traumatic brain injury with persistent upper-limb functional limitation; or orthopedic\u002Fpost-surgical conditions involving the shoulder, elbow, wrist, or hand with persistent functional impairment for more than 3 months\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-2000A, ZEPU-2000D, and ZEPU-2000E systems, 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 less than 24, that would compromise safe participation Severe spasticity of the upper limb, defined as a Modified Ashworth Scale score greater than 3\n* Unstable fractures, severe fixed joint contractures of the shoulder, elbow, wrist, or hand (e.g., greater than 30 degrees), or severe pain limiting safe robotic training\n* Uncontrolled cardiac arrhythmia, or presence of a pacemaker or other implanted electronic medical device incompatible with robotic sensors\n* Pregnancy","ALL","18 Years","60 Years",{"count":118,"type":119},36,"ESTIMATED","INTERVENTIONAL",[122],"NA","The goal of this clinical trial is to learn whether the ZEPU-2000A, ZEPU-2000D and ZEPU-2000E robotic rehabilitation trainers help people with weakness or movement problems in their arms and legs. These devices are used to guide repeated arm and leg movements as part of rehabilitation therapy. The study will also look at whether the devices are safe to use.\n\nThe main questions it aims to answer are:\n\nIs training with the ZEPU-2000 devices safe, and how well do patients tolerate and stick with the training sessions? Does adding robotic training to usual rehabilitation improve muscle strength, joint movement, balance, walking, and daily function more than usual rehabilitation alone?\n\nResearchers will compare a group receiving robotic-assisted rehabilitation plus usual care to a group receiving usual rehabilitation care alone, to see whether the robotic devices provide added benefit.\n\nParticipants will:\n\nBe adults aged 18-60 with arm and\u002For leg movement problems caused by stroke, incomplete spinal cord injury, traumatic brain injury, or an orthopedic condition Attend training sessions 3 times a week for 12 weeks (about 36 sessions total), each lasting approximately 45 minutes Undergo assessments of strength, movement, balance, and daily function at the start of the study and every 2 weeks throughout the 12-week period Be monitored for any side effects or safety concerns, such as skin irritation, falls, or discomfort, at every session",[125,126,127,128,129],"Stroke","Incomplete Spinal Cord Injury (SCI)","Traumatic Brain Injury","Upper Extremity Motor Dysfunction","Lower Extremity Motor Dysfunction",[131,65,69,73,132,133,134],"Robotic rehabilitation","Active and passive rehabilitation","Neurorehabilitation","Musculoskeletal rehabilitation","NOT_YET_RECRUITING","2026-08-04",{"date":138,"type":139},"2026-08-06","ACTUAL",{"date":141,"type":119},"2026-08",{"date":143,"type":119},"2026-12",{"name":5,"class":6},1]