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NOT YET RECRUITING
NCT07434492
PHASE2

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

Sponsor: Shirley Ryan AbilityLab

View on ClinicalTrials.gov

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.

Official title: Smart Ankle-Foot Orthosis and 5-Azacitidine to Enhance Gait and Community Mobility for Children With Cerebral Palsy

Key Details

Gender

All

Age Range

8 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-03-01

Completion Date

2030-08-31

Last Updated

2026-02-25

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Smart Ankle-Foot Orthosis

The Biomotum Ambulo is an adjustable smart AFO device featuring two adjustable spring settings and provides real-time biofeedback using footplate sensors and progressive goal parameters based on individual gait.

DRUG

5-Azacitidine

A subset of opt-in participants will receive a single dose (75mg/m²) of 5-Azacitidine (AZA), an FDA-approved drug for pediatric oncology. A registered nurse will deliver a single subcutaneous injection at midpoint.

DRUG

Placebo

A subset of opt in participants will receive a single dose (75mg/m²) of Mannitol (placebo). A registered nurse will deliver a single subcutaneous injection at midpoint.

Locations (1)

Shirley Ryan AbilityLab

Chicago, Illinois, United States