Robot trainer aims to restore walking after neurological injury

NCT ID NCT07705906

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This trial is taking on new participants right now.
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Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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First seen Jul 15, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This study tests whether a robotic device called ZEPU-AI3 can safely help people with lower limb weakness from stroke, spinal cord injury, or orthopedic surgery improve their walking. Participants receive either standard rehabilitation alone or standard rehab plus robot-assisted training. The trial measures safety, how well people tolerate the device, and changes in walking ability over 12 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot
What this could lead to
If successful, this robot could provide a safe, effective way to improve walking and mobility for people recovering from stroke, spinal cord injury, or orthopedic surgery.
What could go wrong
This is a small pilot study with only 32 participants, so results may not apply to everyone. The device could cause side effects like skin irritation or joint pain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * • 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. * Medically stable and cleared by physician for exoskeleton use (no active infection, uncontrolled cardiac/respiratory disease, severe osteoporosis, uncontrolled epilepsy, untreated DVT) through pre-screening with necessary investigations. Exclusion Criteria: * • 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. * Uncontrolled cardiac arrhythmia, pacemaker incompatibility or implanted electronic device incompatible with robot sensors. Individuals with these conditions may face elevated risk of adverse cardiac events or device malfunction. * Pregnancy as safety data for robotic exoskeleton use in pregnant individuals are lacking.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Bangladesh Medical University

    Dhaka, Dhaka Division, 1000, Bangladesh

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