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Could a cancer drug and smart brace boost mobility in kids with cerebral palsy?

NCT ID NCT07434492

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a smart ankle-foot orthosis (a brace that gives feedback on walking) can improve mobility in 60 children with cerebral palsy. Some participants can also choose to receive a single injection of 5-Azacitidine, a drug used in cancer, to see if it boosts the effects. The goal is to help kids walk farther and move more easily in their communities.

What this could mean

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

Active substance
5-Azacitidine (a cancer drug) and a smart ankle-foot orthosis (a device that gives real-time feedback on walking)
What this could lead to
If it works, this could point toward a new way to improve walking and community mobility for children with cerebral palsy.
What could go wrong
This is a small, early-phase trial with only 60 participants. The drug 5-Azacitidine is not approved for cerebral palsy and may have side effects. The device and drug combination may not provide lasting benefits.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

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

Started

May 2026

Expected to finish

Aug 2030

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 to 17 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 classified as Gross Motor Function Classification System (GMFCS) levels I to III * Between 8 and 17 years and 8 months of age at the time of enrollment/consent. Participants that will turn 18 during the course of the study will not be included as pausing the at-home protocol until re-consenting is possible could interfere with intervention results. * Stable medical condition as determined by the investigator. * Adequate caregiver support to be able to participate in training and assessment sessions for the duration of the study, at the discretion of the PI. * Height/weight/BMI between the 5th - 95th percentile of children with cerebral palsy * Able to walk for at least 6 minutes (assisted or unassisted) * Able to understand and follow simple directions * Able to safely fit into a device configuration and tolerate assistance without knee hyperextension while walking * At least 20 degrees of passive ankle plantar flexion range of motion * Physician approval for participation Exclusion Criteria: * Knee extension or ankle dorsiflexion contractures greater than 15 degrees * Immunodeficiency or hematologic condition * Allergy to AZA or mannitol * Plans to receive a vaccine within 30 days of the planned AZA or placebo injection to take place at week 5 * Pregnancy * Orthopedic surgery on the lower limbs completed in the prior 12 months * New implanted device (e.g., baclofen pump) and/or active intrathecal medication titration that may affect muscle spasticity * Botulinum toxin treatment within 3 months preceding enrollment unless given approval by the study physician * Severe osteoporosis unless given approval by the study physician * Current enrollment in a conflicting research study * Any other health condition or diagnosis not listed above that may put the participant at risk as determined by the PI or study physician

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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

    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

  • Shirley Ryan AbilityLab

    RECRUITING

    Chicago, Illinois, 60611, United States

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