Testing an Adjustable Ankle Orthosis During Walking in Cerebral Palsy

Northern Arizona University (NAU)

Status and phase: Completed; Early Phase 1

Conditions: Cerebral Palsy

Treatments: Device: Differential and adjustable stiffness AFO (DAS-AFO)

Study type: Interventional

Funder types: Other

Identifiers

NCT06262191

2137249

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 8 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 8-35 years old, inclusive
• Diagnosis of cerebral palsy (CP)
• Gross motor functional classification score level I, II, or III
• Physician-prescribed AFOs of common design (i.e., rigid molded thermoplastic)
• Ability to walk for 6 minutes on a treadmill
• At least 20° of passive plantar-flexion range of motion
• No concurrent treatment other than those assigned during the study
• No condition other than CP that would affect safe participation
• No surgery within 6 months of participation.

Exclusion criteria

-Excessive knee flexion during walking caused by CP

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Study group

Experimental group

Description:

Participants will walk with the new AFO, their own AFOs, and no AFOs.

Treatment:

Device: Differential and adjustable stiffness AFO (DAS-AFO)