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Augmenting Ankle Plantarflexor Function in Cerebral Palsy

RecruitingPhase 1Ages 8 Years - 21 YearsAllNorthern Arizona University
NCT05154253 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The first specific aim is to quantify improvement in ankle muscle function and functional mobility following targeted ankle resistance gait training in ambulatory children with cerebral palsy (CP). The primary hypothesis for the first aim is that targeted ankle resistance training will produce larger improvements in lower-extremity motor control, gait mechanics, and clinical measures of mobility assessed four- and twelve-weeks post intervention compared to standard physical therapy and standard gait training. The second specific aim is to determine the efficacy of adaptive ankle assistance to improve capacity and performance during sustained, high-intensity, and challenging tasks in ambulatory children with CP. The primary hypothesis for the second aim is that adaptive ankle assistance will result in significantly greater capacity and performance during the six-minute-walk-test and grade

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📋 Eligibility rules (as published)
Inclusion Criteria: * Ages between 8 and 21 years old, inclusive. Diagnosis of CP and a pathological gait pattern caused by ankle dysfunction. * Able to understand and follow simple directions (based on parent report, if needed) and walk at least 30 feet with or without a walking aid (Gross Motor Function Classification System (GMFCS) Level I-III). * At least 20° of passive plantar-flexion range of motion. Exclusion Criteria: * Concurrent treatment other than those assigned during the study. * A condition other than CP that would affect safe participation. * Surgical intervention within 6 months of participation.
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What it tests

  • Biomotum Spark: Robotic ankle assistance
  • Biomotum Spark: Robotic ankle resistance
  • Standard gait training
  • Ankle foot orthosis
  • Standard physical therapy
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Where

1 site
Gillette Children's Specialty Healthcare
Minneapolis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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