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NCT07750808
ZEPU AI9 Exoskeleton Rehabilitation Robot
Conditions: Stroke, Incomplete Spinal Cord Injury (SCI), Gait Disorders, Neurologic, Lower Extremity Motor Dysfunction
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 36
Sponsor: Bangladesh Medical University
Location: Bangladesh Medical University Dhaka
Summary
The goal of this clinical trial is to learn whether the ZEPU AI9 lower limb exoskeleton robot is feasible, safe, and effective for people with walking difficulty caused by stroke, incomplete spinal cord injury, or orthopedic surgery. The main questions it aims to answer are:
Is exoskeleton-assisted gait training well tolerated, and how often do device-related problems (such as falls, pain, or skin injury) occur? Does adding exoskeleton training to usual rehabilitation improve walking distance, walking speed, balance, muscle strength, and joint movement compared with usual rehabilitation alone? Is it practical to add this robotic training into the rehabilitation program at Bangladesh Medical University?
Researchers will compare a group receiving exoskeleton-assisted gait training plus standard rehabilitation to a group receiving standard rehabilitation alone, to see whether the exoskeleton adds benefit.
Participants will:
Be randomly assigned to either the exoskeleton group or the standard-care group If assigned to the exoskeleton group, attend 45-minute training sessions 3 times a week for 12 weeks, supervised by physical therapists with safety harness support Both groups will continue their usual rehabilitation therapy throughout the study Undergo walking, balance, strength, and quality-of-life assessments at the start of the study and every 2 weeks for 12 weeks Be monitored for any side effects or safety concerns during and after each session
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 and ≤ 60 years.
* 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 \> 3months post-surgery.
* Able to provide informed consent and understand instructions.
* Weight ≤ 100 kg (as per device spec) and height within device adjustable range (manufacturer spec).
* Medically stable and cleared by physician for exoskeleton use (no active infection, uncontrolled cardiac/respiratory disease, severe osteoporosis, uncontrolled epilepsy, untreated DVT) with necessary investigations.
Exclusion Criteria:
* Complete spinal cord injury with inability to bear any weight.
* Severe cognitive impairment (e.g., MMSE \< 24) preventing safe participation.
* Severe spasticity (Modified Ashworth Scale \> 3) in lower limbs.
* Unstable fractures, severe hip/knee contractures (\> 30° fixed flexion), severe osteoarthritis requiring imminent surgery.
* Uncontrolled cardiac arrhythmia, pacemaker incompatibility, or implanted electronic device incompatible with robot sensors.
* Pregnancy.
Source: ClinicalTrials.gov (NCT07750808). StuddyBuddy aggregates publicly available trial information.