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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Recruitment opened
    • Start date changed from estimate of Apr 20, 2026 to May 28, 2026
    • Site details revised
    v4
  2. Secondary endpoints revised (8)v3
  3. Start date: Mar 1, 2026 to Apr 20, 2026v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07434492
Lead Sponsor Shirley Ryan AbilityLab
Conditions
(from sponsor)		 Cerebral Palsy
Related terms Cerebral Palsy
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov