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Smart AFO and 5-Azacitidine for Mobility in Children with Cerebral Palsy

This study is looking at how a smart ankle-foot orthosis (AFO) called the Biomotum Ambulo can help children with Cerebral Palsy (CP) improve their walking. The smart AFO is a device that supports the ankle and foot, and it also helps with exercises. Some participants will also have the option to receive a single injection of either 5-Azacitidine, a drug approved for other uses, or a placebo (an inactive substance like Mannitol). Researchers want to see if combining the smart AFO with 5-Azacitidine can further improve mobility. You may be able to join if you are 8 to 17 years old and have been diagnosed with CP, specifically GMFCS levels I to III. The main goal is to see how far participants can walk in 6 minutes after about 13 weeks. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 60 participants. A subset of participants will be randomly assigned to receive either 5-Azacitidine or a placebo.
What's involved
Participants will complete a three-phase protocol, including 6 weeks of at-home training with the smart AFO. A registered nurse will deliver a single subcutaneous injection at midpoint for those opting into the drug portion.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at approximately 13 weeks after baseline.

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NCT07434492

Smart AFO and 5-Azacitidine to Enhance Mobility in Children With Cerebral Palsy

Recruiting
PHASE2Ages 8–17Interventional
Shirley Ryan AbilityLab
~60 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Smart Ankle-Foot Orthosis5-AzacitidinePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
6 Minute Walking Test
Measured over Baseline to Follow-Up, approximately 13 weeks

Conditions

Cerebral Palsy

Explore related trials

Cerebral Palsy

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Megan O'Brien, PhD · PRINCIPAL_INVESTIGATOR · Shirley Ryan AbilityLab

Who to contact

Audrey Wiesner, BS
[email protected]
3122388435
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 6 Minute Walking TestBaseline to Follow-Up, approximately 13 weeks

    Participants will complete a 6 minute walking test to measure the total distance they can walk in a 6 minute period.