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Taking people in United StatesPhase 2

Smart ankle brace with 5-Azacitidine to help children with cerebral palsy move

Tests a smart ankle brace, with or without 5-Azacitidine, in children with cerebral palsy.

Key facts

Who runs it
Shirley Ryan AbilityLab
Where
Chicago, United StatesSee the site
Trial code
Registry title
Smart AFO and 5-Azacitidine to Enhance Mobility in Children With Cerebral Palsy
Status
Recruiting
Phase
Phase 2
People taking part
60 people, planned
Started
28 May 2026
Expected to end
31 Aug 2030
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Smart Ankle-Foot Orthosis
  • 5-Azacitidine
  • Placebo
Record updated
1 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children with cerebral palsy who can walk, to test a smart ankle-foot brace (AFO) used at home. Some may also choose to join a part testing 5-Azacitidine or a placebo injection.

Age
8 to 17 years. Children who will turn 18 during the study cannot join.
Sex
All sexes
Disease stage
Cerebral palsy at GMFCS levels I to III. Must be able to walk for at least 6 minutes, with or without help. Must have a stable medical condition.
Earlier treatment
No lower-limb bone or joint surgery in the prior 12 months. No Botulinum toxin in the 3 months before joining, unless the study doctor approves.

Main reasons for not taking part

  • Knee or ankle stiffness (contractures) greater than 15 degrees
  • Weak immune system or a blood disorder
  • Allergy to AZA or mannitol
  • Pregnancy
  • New implanted device (such as a baclofen pump) or changing spinal medicine doses that affect muscle stiffness

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Plans to receive a vaccine within 30 days of the planned AZA or placebo injection to take place at week 5
  • 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
  • Immunodeficiency or hematologic condition
  • Allergy to AZA or mannitol
  • Any other health condition or diagnosis not listed above that may put the participant at risk as determined by the PI or study physician
  • Knee extension or ankle dorsiflexion contractures greater than 15 degrees
  • Pregnancy
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 8 and 17 years old?

Where in United States

  • Shirley Ryan AbilityLabChicago, United StatesContact: Audrey Wiesner, BSTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Smart AFO & Home Intervention Training + 5-AzacitidineTreatment being tested

    Participants will receive one Smart AFO device for use during the at-home intervention phase of the study. Participants will be asked to complete and log at least three 30-minute gait training sessions per week at home with the device. Each session will involve: 1. Walking for 5-10 minutes intervals for 3 trials, with the goal of performing at a 7/10 on the Pictorial Children's Effort Rating Table (PCERT) 2. Monitoring Heart Rate 3. Caregiver filling out brief log to track training session details. A subset of opt-in participants will also be randomized to receive either 5-azacitidine (VIDAZA) or placebo (Mannitol) at midpoint. A registered nurse will deliver a single subcutaneous injection of either AZA or placebo at a dose of 75 mg/m² to the participants lower abdomen or medial thigh.

    Treatment: Smart Ankle-Foot Orthosis and 5-Azacitidine

  • Smart AFO & Home Intervention Training + Mannitol (Placebo)Existing treatment, for comparison

    Participants will receive one Smart AFO device for use during the at-home intervention phase of the study. Participants will be asked to complete and log at least three 30-minute gait training sessions per week at home with the device. Each session will involve: 1. Walking for 5-10 minutes intervals for 3 trials, with the goal of performing at a 7/10 on the Pictorial Children's Effort Rating Table (PCERT) 2. Monitoring Heart Rate 3. Caregiver filling out brief log to track training session details. A subset of opt-in participants will also be randomized to receive either 5-azacitidine (VIDAZA) or placebo (Mannitol) at midpoint. A registered nurse will deliver a single subcutaneous injection of either AZA or placebo at a dose of 75 mg/m² to the participants lower abdomen or medial thigh.

    Treatment: Smart Ankle-Foot Orthosis and Placebo

  • Smart AFO & Home Intervention TrainingExisting treatment, for comparison

    Participants will receive one Smart AFO device for use during the at-home intervention phase of the study. Participants will be asked to complete and log at least three 30-minute gait training sessions per week at home with the device. Each session will involve: 1. Walking for 5-10 minutes intervals for 3 trials, with the goal of performing at a 7/10 on the Pictorial Children's Effort Rating Table (PCERT) 2. Monitoring Heart Rate 3. Caregiver filling out brief log to track training session details.

    Treatment: Smart Ankle-Foot Orthosis

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Smart Ankle-Foot Orthosis and 5-Azacitidine to Enhance Gait and Community Mobility for Children With Cerebral Palsy
Plain-language title
Smart ankle brace with 5-Azacitidine to help children with cerebral palsy moveGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07434492, who can take part
Record updated
1 June 2026