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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional study evaluates the Biomotum Ambulo smart ankle-foot orthosis (AFO) for improving gait and mobility in children with cerebral palsy (GMFCS I–III). Participants undergo a 6-week at-home training program with the smart AFO and may opt into a 1:1 randomization to receive 5-azacitidine or placebo to explore potential additive effects on muscle function. The study also collects blood samples to examine genetic and epigenetic factors related to musculoskeletal outcomes and responses to the interventions. Primary aims include improvements in walking ability and ankle mechanics, driven by both mechanical support and progressive resistance-based exercise. The trial is conducted at Shirley Ryan AbilityLab in Chicago, with appropriate caregiver involvement and safety monitoring.

Why it matters

Who can join: the full rules

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

Where it's running

• Shirley Ryan AbilityLab
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Megan O'Brien, PhD — Shirley Ryan AbilityLab
• Study coordinator: Audrey Wiesner, BS
• Email: awiesner@sralab.org
• Phone: 3122388435

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy

  This study tests whether Sensory Integration Therapy helps improve gross motor function more than standard physical therapy in children aged 4–10 with mixed cerebral palsy.

  Recruiting Riphah International University · Peshawar, Kpk · NCT07921069

• Turkish version of ABILHAND-Kids Young CP: translation, adaptation, and reliability

  A Turkish version of the ABILHAND-Kids Young CP questionnaire is being created and tested to see if it reliably measures manual ability in 2-to-7-year-olds with cerebral palsy, based on parent reports.

  Recruiting Istanbul University - Cerrahpasa · Istanbul, Istanbul · NCT07894926

• Multisite upper limb surgery in children with unilateral cerebral palsy

  This study looks at whether individualized multisite upper limb surgery helps improve hand function in kids with hemiplegic cerebral palsy, using each child as their own control before and after surgery.

  Recruiting Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française · Lyon · NCT07891078

• Spinal Stimulation During Walking to See If Spasticity Lessens in Cerebral Palsy

  This study tests whether walking with non-invasive spinal stimulation reduces leg muscle tightness and improves walking in children and young adults with cerebral palsy.

  Recruiting University of Washington · Seattle, Washington · NCT07826494

• Combined leg nerve blocks for kids with cerebral palsy after surgery

  This study tests whether adding two nerve blocks to standard anesthesia helps control pain in children with cerebral palsy after lower limb surgery.

  Recruiting Diskapi Yildirim Beyazit Education and Research Hospital · Ankara · NCT07801365

• Smartphone gait checks for kids with unilateral spastic CP

  This study tests whether a phone’s accelerometer can reliably measure walking in children with unilateral spastic cerebral palsy.

  Recruiting Deraya University · Minya, Menia Governorate · NCT07730086

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.