Testing an Adjustable Ankle Orthosis During Walking in Cerebral Palsy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-06-01

Brief Summary

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

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Detailed Description

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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

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Cerebral Palsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study group

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

Group Type EXPERIMENTAL

Differential and adjustable stiffness AFO (DAS-AFO)

Intervention Type DEVICE

Walking with a differential and adjustable stiffness AFO (DAS-AFO)

Interventions

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Differential and adjustable stiffness AFO (DAS-AFO)

Walking with a differential and adjustable stiffness AFO (DAS-AFO)

Intervention Type DEVICE

Eligibility Criteria

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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.