NCT06262191

Testing an Adjustable Ankle Orthosis During Walking in Cerebral Palsy

An Adjustable Stiffness Orthosis to Maintain Muscle Engagement and Push-off Power in Cerebral Palsy

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Northern Arizona University · Academic / Other
• Sex: All
• Age: 8 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to determine how an adjustable stiffness ankle braces affects walking performance and biomechanics in cerebral palsy.

Detailed description

Our first aim is to confirm that the differential and adjustable stiffness (DAS) AFO improves plantarflexor push-off power and range of motion compared to standard (physician prescribed) AFOs during walking in CP. Our second aim is to confirm that the differential and adjustable stiffness (DAS) AFO improves plantarflexor muscle activity while maintaining improved posture compared to standard AFOs during walking in CP. Our third aim is to validate the need and usability of real-time stiffness adjustment during play and school activities; obtain feedback from the children, their parents, and orthotists to design the MVP.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
DEVICE	Differential and adjustable stiffness AFO (DAS-AFO)	Walking with a differential and adjustable stiffness AFO (DAS-AFO)

Timeline

• Start date: 2024-05-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2024-02-15
• Last updated: 2025-05-25
• Results posted: 2025-05-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study