ZEPU AI9 Exoskeleton Rehabilitation Robot

September 10, 2026 updated by: Md. Abdus Shakoor, Ph.D., Bangladesh Medical University

Feasibility, Safety and Efficacy of ZEPU AI9 Lower Limb Exoskeleton Rehabilitation Robot in Patients With Lower Limb Motor Dysfunction

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Lower-limb motor dysfunction following stroke, incomplete spinal cord injury, and orthopedic surgery is a major contributor to disability in low- and middle-income countries, where access to intensive, repetitive gait training is often limited by shortages of rehabilitation professionals and structured multidisciplinary programs. Robotic-assisted gait training has emerged as a way to deliver consistent, task-specific, and intensity-controlled practice that is difficult to achieve with therapist-delivered conventional therapy alone, by enabling programmable gait cycles with controlled step length, cadence, symmetry, and body-weight support.

The ZEPU-AI9 is a dual-leg, passive-training lower-limb exoskeleton (Shandong Zepu Medical Technology Co., Ltd.) that generates repeated physiological gait cycles through motorized hip and knee joints while maintaining ankle alignment within a controlled range. It supports standing, sitting, stepping-in-place, and over-ground walking modes via a touchscreen interface and handheld steering joystick, with adjustable thigh/calf length, height, waist width, joint movement angles, step length, and training duration to accommodate individual anthropometrics. Built-in safety features include an emergency stop, automated spasm protection, mechanical joint limits, overload detection, low-battery alarms, and anti-tilt protection, supplemented by an overhead fall-arrest harness during supervised sessions. Powered lower-extremity exoskeletons are classified as Class II medical devices by the U.S. FDA (product code PHL), reflecting both their therapeutic potential and the need for supervised clinical use and standardized protocols. No clinical data on the ZEPU-AI9 currently exist from Bangladesh, and its performance within a Bangladeshi rehabilitation setting has not been evaluated.

This single-site pilot randomized controlled trial will be conducted at the Robotic Rehabilitation Centre, Department of Physical Medicine and Rehabilitation, Bangladesh Medical University. Following screening and informed consent, eligible participants will be randomized to receive either ZEPU-AI9-assisted gait training in addition to standard-of-care rehabilitation, or standard-of-care rehabilitation alone, over a 12-week intervention period. Exoskeleton sessions will be conducted three times weekly (45 minutes each, comprising warm-up, device donning, structured gait training, and cool-down), supervised by physiatrists and physiotherapists trained in robotic rehabilitation, with training parameters progressively adjusted based on participant performance and tolerance. Pre- and post-session safety checks (vital signs, skin integrity, pain/fatigue via VAS) will be performed at every session, with device-related adverse events recorded in real time.

Standardized assessments (6-Minute Walk Test, Manual/MRC Muscle Strength Testing, Functional Ambulation Category, Berg Balance Scale, Timed Up and Go test, Modified Ashworth Scale, and a validated Bengali quality-of-life measure) will be administered at baseline and at two-week intervals through week 12, allowing paired comparison of pre- and post-intervention values. Feasibility will additionally be evaluated through recruitment and screening metrics, session adherence and dropout rates, therapist training time, device set-up and donning/doffing time, and a Post-Study System Usability Questionnaire administered at study completion.

Data will be analyzed on an intention-to-treat basis (all randomized participants analyzed per original group assignment), with a secondary per-protocol analysis restricted to participants completing the intervention as specified. Continuous variables will be summarized as mean ± SD (or median/IQR where non-normally distributed) and compared using paired or unpaired t-tests, or Wilcoxon signed-rank tests as appropriate, with statistical significance set at p<0.05. Findings from this pilot study are intended to generate feasibility indicators and preliminary effect-size estimates to inform the design of a future, adequately powered randomized controlled trial and to guide national implementation strategies for robotic rehabilitation in Bangladesh.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1000
        • Recruiting
        • Bangladesh Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Robotic-Augmented Rehabilitation Group
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
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.
Behavioral: Standard-of-Care Rehabilitation
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).
Active Comparator: Usual Care Group
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
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Device-Related Adverse Events and Serious Adverse Events
Time Frame: Baseline (T0) to 12 weeks, assessed at 2-week intervals
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
Time Frame: Baseline (T0) to 12 weeks, assessed at 2-week intervals
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Walking Distance on 6-Minute Walk Test
Time Frame: Baseline (T0) to 12 weeks, assessed at 2-week intervals
Distance walked (in meters) in 6 minutes, used to assess functional exercise capacity and gait endurance.
Baseline (T0) to 12 weeks, assessed at 2-week intervals
Change in Lower-Limb Muscle Strength (MRC Scale)
Time Frame: Baseline (T0) to 12 weeks, assessed at 2-week intervals]
Lower-limb muscle strength assessed using the Medical Research Council (MRC) Muscle Strength Scale, graded 0-5 for key muscle groups.
Baseline (T0) to 12 weeks, assessed at 2-week intervals]
Change in Functional Ambulation Category (FAC) Score
Time Frame: Baseline (T0) to 12 weeks, assessed at 2-week intervals]
Level of walking independence assessed using the Functional Ambulation Category, scored 0 (non-ambulatory) to 5 (independent on all surfaces).
Baseline (T0) to 12 weeks, assessed at 2-week intervals]
Change in Berg Balance Scale (BBS) Score
Time Frame: Baseline (T0) to 12 weeks, assessed at 2-week intervals
Balance ability assessed using the Berg Balance Scale, a 14-item performance-based measure scored 0-56, with higher scores indicating better balance.
Baseline (T0) to 12 weeks, assessed at 2-week intervals
Change in Timed Up and Go (TUG) Test
Time Frame: Baseline and every 2 weeks through 12 weeks
Time (in seconds) taken to rise from a chair, walk 3 meters, turn, walk back, and sit down, used to assess functional mobility and fall risk.
Baseline and every 2 weeks through 12 weeks
Change in Lower-Limb Spasticity (Modified Ashworth Scale)
Time Frame: Baseline and every 2 weeks through 12 weeks
Muscle tone and spasticity in the lower limbs assessed using the Modified Ashworth Scale (MAS), a 6-point ordinal scale (0 to 4, including 1+).
Baseline and every 2 weeks through 12 weeks
Change in Quality of Life (EuroQol Questionnaire)
Time Frame: Baseline and every 2 weeks through 12 weeks
Health-related quality of life assessed using the EuroQol (EQ-5D) questionnaire, validated Bengali version, covering mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Baseline and every 2 weeks through 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bangladesh Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Md. Abdus Shakoor, Ph.D., Bangladesh Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PR-1422

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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