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Can a standardized protocol improve Ankle-Foot orthosis care for children with cerebral palsy?

NCT ID NCT07811336

Symptom relief Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Ankle-foot orthoses (AFOs) help children with cerebral palsy walk better, but how they are prescribed and fitted varies widely. Researchers are testing a standardized protocol that guides healthcare professionals on AFO selection, training, and evaluation. The trial compares usual AFO care with the optimized approach in 86 children with cerebral palsy, measuring how well each child reaches personal walking goals after three months and whether the new approach saves money.

What this could mean

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

Active substance
a standardized protocol for ankle-foot orthosis care
What this could lead to
If it works, this could give clinicians a clearer, more consistent way to prescribe and fit ankle-foot orthoses for children with cerebral palsy, helping more children reach their walking goals.
What could go wrong
The trial is small, with 86 children in total, and it compares a new protocol against usual care rather than a placebo. The approach may not work better than current practice, and results in the Netherlands may not apply elsewhere.

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 86 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2031

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

2 to 18 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: * Diagnosis of cerebral palsy * Age range from independent walking onset up to 18 years * Ability to walk independently with or without a walking aid (e.g., a walker) * Indication for a first or repeated prescription of AFO for daytime use to improve gait function Exclusion Criteria: * Orthopaedic or neurosurgical surgery within the past 6 months (e.g., SDR) * Child and parent do not speak Dutch

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Conditions

The condition(s) this trial relates to.

cerebral palsy Personal Satisfaction

As listed by the trial registrant

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

Cerebral palsy (CP)

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

  • Amsterdam UMC, location AMC

    Amsterdam, North Holland, 1105 AZ, Netherlands

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