ZEPU-AI3 Lower Limb Feedback Robot Training Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBangladesh Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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/hip 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.
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.
Able to provide informed consent and understand instructions which ensures participants can actively engage in therapy, follow safety instructions and report adverse events.
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.
Disqualifiers
• 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.
Severe cognitive impairment (e.g., MMSE < 24) preventing safe participation.
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.
Unstable fractures, severe hip/knee contractures (> 30° fixed flexion), severe osteoarthritis requiring imminent surgery. They can pose high risk for injury during weight-bearing or gait cycles.
Trial design
Design model
Parallel
Treatments tested in this trial
ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot
DeviceParticipants 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.
Conventional Rehabilitation
Other interventionParticipants 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.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: ZEPU-AI3 + Conventional RehabilitationExperimental treatment 2 interventions
Group B: Conventional RehabilitationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline through Week 122
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.
Time frame
Baseline through Week 12Secondary outcomes
1
Change in 6-Minute Walk Test Distance
Change in walking endurance assessed using the 6-Minute Walk Test (6MWT)
Time frame
Baseline and Week 122
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).
Time frame
Baseline and Week 123
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).
Time frame
Baseline and Week 124
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).
Time frame
Baseline and Week 12Sponsors and contacts
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Source ClinicalTrials.gov
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