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3D-Printed ankle braces put to the test against Old-School plaster casts

NCT ID NCT06828653

Symptom relief Sponsor: Holland Bloorview Kids Rehabilitation Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether ankle braces made with 3D scanning and printing work as well as those made the old-fashioned way with plaster casts. About 50 people aged 8 and older with leg weakness from conditions like cerebral palsy, stroke, or spinal cord injury will try both types of braces. The goal is to see if the digital method is just as good at improving mobility and comfort, while being faster and cheaper to produce.

What this could mean

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

Active substance
ankle foot orthosis (brace) made by digital or traditional methods
What this could lead to
If digital braces work as well as traditional ones, they could be made faster and cheaper, improving access for people who need them.
What could go wrong
This is a small early feasibility study with only 50 people, so results may not apply to everyone. Digital braces might not fit or perform as well as custom plaster ones.

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 50 people

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

Started

Sep 2025

Expected to finish

Mar 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

8 years and older

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: * Participants must be aged 8 years or older. * Participants should have either flaccid or spastic paresis resulting from conditions such as cerebral palsy, stroke, spinal cord injury, spina bifida, or traumatic peripheral nerve injury, leading to lower limb mobility impairments. * Participants must require a custom articulating, rigid, or energy storage and return (ESR) AFO to improve physical function for one or both sides (unilateral or bilateral). * Participants must be able to ambulate independently, though the use of gait aids is permitted. * Participants must be capable of completing questionnaires with no more than orienting guidance. * Participants must meet the requirements to have their AFO funded by the Assistive Devices Program (ADP). Exclusion Criteria: * Clients for whom the primary goal of the AFO includes wound management. * Those whose AFO is not worn for ambulation. * Clients with insensate feet or a history of ulcerations. * First-time AFO users.

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Conditions

The condition(s) this trial relates to.

cerebral palsy spina bifida spinal cord injury stroke disorder traumatic neuropathy

As listed by the trial registrant

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

Cerebral palsy Flaccid paresis Spastic paresis Spina bifida Spinal cord injury Stroke Traumatic peripheral nerve injury

How to take part

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

  1. The places running it

    2 sites. 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

  • Boundless Biomechanical Bracing

    NOT_YET_RECRUITING

    Mississauga, Ontario, L4W5A8, Canada

  • Holland Bloorview Kids Rehabilitation Hospital

    RECRUITING

    Toronto, Ontario, M4G1R8, Canada

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