ZEPU AI9 Exoskeleton Rehabilitation Robot

NCT07750808 | Not Yet Recruiting DMC

• 1 other identifier: PR-1422
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Stroke; Incomplete Spinal Cord Injury (SCI); Lower Extremity Motor Dysfunction; Gait Disorders, Neurologic

Keywords

Lower limb exoskeleton; Robotic Rehabilitation; Neurorehabilitation

Outcome Measures

Primary Outcomes (2)

• Incidence of Device-Related Adverse Events and Serious Adverse Events

  Number and proportion of participants experiencing device-related adverse events (AEs) and serious adverse events (SAEs), including falls, skin breakdown/pressure sores, joint pain or injury, cardiovascular events, fracture, and device malfunction, during the 12-week intervention and follow-up period.

  Baseline (T0) to 12 weeks, assessed at 2-week intervals

• Device Tolerability

  Tolerability of ZEPU-AI9 exoskeleton training assessed as the number of sessions completed versus sessions planned, number of participant dropouts, and reasons for dropout, during the 12-week intervention period.

  Baseline (T0) to 12 weeks, assessed at 2-week intervals

Secondary Outcomes (7)

• Change in Walking Distance on 6-Minute Walk Test

  Baseline (T0) to 12 weeks, assessed at 2-week intervals

• Change in Lower-Limb Muscle Strength (MRC Scale)

  Baseline (T0) to 12 weeks, assessed at 2-week intervals]

• Change in Functional Ambulation Category (FAC) Score

  Baseline (T0) to 12 weeks, assessed at 2-week intervals]

• Change in Berg Balance Scale (BBS) Score

  Baseline (T0) to 12 weeks, assessed at 2-week intervals

• Change in Timed Up and Go (TUG) Test

  Baseline and every 2 weeks through 12 weeks

Study Arms (2)

Robotic-Augmented Rehabilitation Group

EXPERIMENTAL

Participants will receive ZEPU-AI9 exoskeleton-assisted gait training in addition to standard-of-care rehabilitation. Exoskeleton sessions will be conducted 3 times per week for 12 weeks (45 minutes/session, including donning, warm-up, structured gait training, and cool-down), supervised by trained physiatrists and physiotherapists with safety harness support. Training parameters will be progressively adjusted based on participant performance and tolerance. Standard rehabilitation (balance training, lower-limb strengthening, stretching, gait retraining) will continue in parallel per institutional protocol.

Device: ZEPU-AI9 Lower Limb Exoskeleton Gait Training; Behavioral: Standard-of-Care Rehabilitation

Usual Care Group

ACTIVE COMPARATOR

Participants will receive standard-of-care rehabilitation alone (balance training, lower-limb strengthening, stretching, gait retraining) per institutional protocol, without ZEPU-AI9 exoskeleton-assisted training, over the 12-week study period.

Behavioral: Standard-of-Care Rehabilitation

Interventions

ZEPU-AI9 Lower Limb Exoskeleton Gait Training DEVICE

A powered, dual-leg lower-limb exoskeleton (Shandong Zepu Medical Technology Co., Ltd.) that generates repeated physiological gait cycles via motorized hip and knee joints, supporting standing, sitting, stepping-in-place, and over-ground walking. Adjustable thigh/calf length, height, waist width, joint angles, step length, and training duration accommodate individual anthropometrics. Participants will use the device 3 times per week for 12 weeks (45-minute sessions), supervised by trained physiatrists/physiotherapists, with an overhead safety harness. Training parameters are progressively adjusted based on performance. Safety features include emergency stop, automated spasm protection, mechanical joint limits, overload detection, and anti-tilt protection. Used in addition to standard-of-care rehabilitation.

Robotic-Augmented Rehabilitation Group

Standard-of-Care Rehabilitation BEHAVIORAL

Institutional standard rehabilitation therapy delivered by physiotherapists, comprising balance training, lower-limb strengthening exercises, stretching, and gait retraining, per Department of Physical Medicine and Rehabilitation protocol at Bangladesh Medical University. Received by all participants throughout the 12-week study period, either alone (Usual Care Group) or in combination with ZEPU-AI9 exoskeleton-assisted gait training (Robotic-Augmented Rehabilitation Group).

Robotic-Augmented Rehabilitation Group; Usual Care Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Bangladesh Medical University

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Md. Abdus Shakoor, Ph.D.

  Bangladesh Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Md. Abdus Shakoor, Ph.D.

CONTACT

+8801819410080; shakoorma@bmu.ac.bd

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman & Professor, Department of Physical Medicine & Rehabilitation and Focal Person, Robotic Rehabilitation Centre, Bangladesh Medical University

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)