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Recruiting Phase 1 NCT05154253

Augmenting Ankle Plantarflexor Function in Cerebral Palsy

Trial Parameters

Condition Cerebral Palsy
Sponsor Northern Arizona University
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 36
Sex ALL
Min Age 8 Years
Max Age 21 Years
Start Date 2023-02-01
Completion 2026-09-14
Interventions
Biomotum Spark: Robotic ankle assistanceBiomotum Spark: Robotic ankle resistanceStandard gait training

Brief Summary

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 graded treadmill and stair stepping protocols compared to walking with ankle foot orthoses and walking with just shoes.

Eligibility Criteria

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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