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New robot boot aims to fix foot drop after stroke

NCT ID NCT04934787

Symptom relief Sponsor: The Hong Kong Polytechnic University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests a wearable robot called ENMS-BSF that combines soft muscles, electrical stimulation, and balance feedback to correct foot drop and foot inversion after a stroke. Sixty people who had a stroke at least six months ago and have mild-to-moderate walking problems will use the device in 20 training sessions. The goal is to see if it improves their walking pattern and muscle control.

What this could mean

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

Active substance
ENMS-BSF device (wearable robot combining soft pneumatic muscles, electrical stimulation, exoskeleton, and balance feedback)
What this could lead to
If it works, this could offer a new way to improve walking and muscle control for people with foot drop after stroke, potentially with lasting benefits.
What could go wrong
This is an early-stage, small trial (60 people) testing a device, not a drug. Results may not apply to all stroke survivors, and the device may not work for everyone or provide long-term improvement.

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 60 people

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

Started

Jul 2021

Expected to finish

Dec 2027

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: * At least 6 months after the onset of stroke * Have sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment (Mini-Mental State Examination (MMSE) score \>21). * Have mild-to-moderate motor impairment in the affected lower limb with foot drop but be capable of standing and walking without manual assistance. * Fugl-Meyer Assessment (FMA), total score on the lower limb \<20 * Functional Ambulatory Category (FAC) ≥4 * Berg Balance Scale (BBS) ≥40 Exclusion Criteria: * The exclusion criteria will be server spasticity at the ankle joint measured by Modified Ashworth Score (MAS) \>3. * Receiving other lower limb rehabilitative interventions at the same time

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Conditions

The condition(s) this trial relates to.

cerebral infarction clubfoot peroneal neuropathy stroke disorder

As listed by the trial registrant

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

Cerebrovascular stroke Foot drop Foot inversion deformity

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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Hong Kong Polytechnic University

    RECRUITING

    Hong Kong, China

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