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Smart AFO and 5-Azacitidine to Enhance Mobility in Children With Cerebral Palsy
Smart Ankle-Foot Orthosis and 5-Azacitidine to Enhance Gait and Community Mobility for Children With Cerebral Palsy
Who can join
Ages 8 to 17 · All sexes
Full 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
About the study
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.
What is being tested
- Smart Ankle-Foot Orthosis (device)
- 5-Azacitidine (drug)
- Placebo (drug)
Sponsor: Shirley Ryan AbilityLab · Participants: 60 · Started: May 28, 2026
Contact the study team
- Audrey Wiesner, BS · Phone: 3122388435
- Jacklyn Stoller, PT, DPT · Phone: 3122387620
Official record on ClinicalTrials.gov — NCT07434492
Locations in the U.S.
| Illinois | Shirley Ryan AbilityLab, Chicago |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.