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RECRUITING
NCT05154253
PHASE1

Augmenting Ankle Plantarflexor Function in Cerebral Palsy

Sponsor: Northern Arizona University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

8 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2023-02-01

Completion Date

2026-09-25

Last Updated

2026-03-03

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Biomotum Spark: Robotic ankle assistance

A lightweight assistive wearable ankle robotic device.

DEVICE

Biomotum Spark: Robotic ankle resistance

A lightweight resistive wearable ankle robotic device.

OTHER

Standard gait training

Standard gait training without a device.

DEVICE

Ankle foot orthosis

Standard ankle foot orthosis

OTHER

Standard physical therapy

Physical therapy without a device.

OTHER

Standard walking

Walking without a device

Locations (1)

Gillette Children's Specialty Healthcare

Minneapolis, Minnesota, United States