NCT07434492 Smart AFO and 5-Azacitidine to Enhance Mobility in Children With Cerebral Palsy
| NCT ID | NCT07434492 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shirley Ryan AbilityLab |
| Condition | Cerebral Palsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-05-28 |
| Primary Completion | 2030-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2026-05-28 with a primary completion date of 2030-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an intervention study to investigate the impact of a smart ankle-foot orthosis (AFO) on mobility outcomes in children with Cerebral Palsy. Participants will complete a three phase protocol including 6-weeks of at home training with the smart AFO. Participants will also have the option to participate in a randomized control trial to investigate the impact of 5-Azacitidine combined with the smart AFO to further effect mobility outcomes.
Eligibility Criteria
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
Contact & Investigator
Megan O'Brien, PhD
PRINCIPAL INVESTIGATOR
Shirley Ryan AbilityLab
Frequently Asked Questions
Who can join the NCT07434492 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 17 Years, studying Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07434492 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07434492 currently recruiting?
Yes, NCT07434492 is actively recruiting participants. Contact the research team at awiesner@sralab.org for enrollment information.
Where is the NCT07434492 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT07434492 clinical trial?
NCT07434492 is sponsored by Shirley Ryan AbilityLab. The principal investigator is Megan O'Brien, PhD at Shirley Ryan AbilityLab. The trial plans to enroll 60 participants.
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