ZEPU-AI Series Limb Feedback Robot Training Study (ZEPUAISRCT)

Sponsor
Bangladesh Medical University
Study ID
NCT07749625
Status
Not Yet Recruiting

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Conditions

  • Brain Injuries, Traumatic
  • Movement Disorder, Lower Extremity
  • Movement Disorder, Upper Extremity
  • Spinal Cord Injuries
  • Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • ZEPU-AI2 — DEVICE
    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/week for 12 weeks in addition to standard physiotherapy.
  • ZEPU-AI4 — DEVICE
    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/week for 12 weeks in addition to standard physiotherapy.
  • ZEPU-AI6 Plus — DEVICE
    Multi-axis robotic arm device that simulates physiological upper-limb movement patterns for three-dimensional active and passive training, used 3 sessions/week for 12 weeks in addition to standard physiotherapy.
  • ZEPU-AI7A — DEVICE
    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/week for 12 weeks in addition to standard physiotherapy.
  • Standard-of-Care Physiotherapy — BEHAVIORAL
    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.

Study Details

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: Is 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? The 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. Participants will: Receive 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

Key Dates

First listed
Aug 6, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Robotic-Augmented Rehabilitation (Intervention)
    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/week (\~45 min each) for 12 weeks (36 sessions total), including warm-up, device donning, structured training (upper/lower limb, gait, or isokinetic depending on device), and cool-down, delivered under supervision of trained physiotherapists.
  • Active Comparator: Usual Care (Control)
    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.

Primary Outcome Measure

Incidence of Device-Related Adverse Events and Serious Adverse Events [ Time Frame: Baseline (T0) to 12 weeks, assessed at 2-week intervals ]

Central Contacts

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