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New ankle brace aims to fix foot drop after stroke

NCT ID NCT03668561

Symptom relief Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a brace called CALIGALOC designed to correct foot drop (ankle varus) in people with hemiparesis after a stroke or other brain injury. The goal was to see if wearing the brace for 15 days improved walking speed and balance. Only 5 people took part, and the study was stopped early, so the results are very limited.

What this could mean

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

Active substance
CALIGALOC ankle-foot orthosis (brace)
What this could lead to
If it works, this brace could help people with foot drop after stroke walk more easily and safely.
What could go wrong
The trial was terminated early and included only 5 people, so we cannot draw reliable conclusions. The brace may not help everyone or may be uncomfortable to wear.

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

5 people

The number who actually took part.

Started

Feb 2019

Finished

Nov 2021

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 80 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: * Hemiparesis at \> 3 months (whatever the etiology) * varus or equinovarus foot disturbing the stance phase of gait * Able to walk at least 10m, with or without assistive device Exclusion Criteria: * unable to walk 10m * Botulinum toxin injection less than 3 months before inclusion * history of neurological or locomotor pathology in addition to the etiology of hemiparesis * Severe comprehension troubles * Pregnancy

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Conditions

The condition(s) this trial relates to.

hemiplegia Paresis stroke disorder

As listed by the trial registrant

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

Hemiparesis Varus deformity of equine carpus

Contacts and locations

Locations

  • Hôpital Swynghedau, CHI

    Lille, France

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