RecruitingPhase 1NCT05154253

Augmenting Ankle Plantarflexor Function in Cerebral Palsy

Augmenting Ankle Plantarflexor Function and Walking Capacity in Children With Cerebral Palsy


Sponsor

Northern Arizona University

Enrollment

36 participants

Start Date

Feb 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 8 YearsMax Age: 21 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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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Interventions

DEVICEBiomotum Spark: Robotic ankle assistance

A lightweight assistive wearable ankle robotic device.

DEVICEBiomotum Spark: Robotic ankle resistance

A lightweight resistive wearable ankle robotic device.

OTHERStandard gait training

Standard gait training without a device.

DEVICEAnkle foot orthosis

Standard ankle foot orthosis

OTHERStandard physical therapy

Physical therapy without a device.

OTHERStandard walking

Walking without a device


Locations(1)

Gillette Children's Specialty Healthcare

Minneapolis, Minnesota, United States

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NCT05154253


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