Comparing Digitally and Traditionally Made Ankle Foot Orthoses

Launched by HOLLAND BLOORVIEW KIDS REHABILITATION HOSPITAL · Feb 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to create Ankle Foot Orthoses (AFOs), which are supportive devices that help people with mobility issues in their legs. The first method is traditional, where a mold is made from a plaster cast of the limb, while the second method uses modern technology like 3D scanning and printing to design and make the AFOs. The goal is to see if the AFOs made with digital technology are just as effective as the traditional ones while being faster and possibly less expensive to produce.

To participate in this trial, you need to be at least 8 years old and have specific conditions that cause lower limb movement problems, such as cerebral palsy or a spinal cord injury. You should be able to walk on your own, even if you use some aids, and need a custom AFO to help you move better. During the trial, participants will be asked to wear the AFOs and complete some questionnaires about their experience. It's important to note that this trial is not yet recruiting participants. If you have any questions about whether you or your loved one might be eligible, feel free to reach out for more details!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants must be aged 8 years or older.
• • Participants should have either flaccid or spastic paresis resulting from conditions such as cerebral palsy, stroke, spinal cord injury, spina bifida, or traumatic peripheral nerve injury, leading to lower limb mobility impairments.
• • Participants must require a custom articulating, rigid, or energy storage and return (ESR) AFO to improve physical function for one or both sides (unilateral or bilateral).
• • Participants must be able to ambulate independently, though the use of gait aids is permitted.
• • Participants must be capable of completing questionnaires with no more than orienting guidance.
• • Participants must meet the requirements to have their AFO funded by the Assistive Devices Program (ADP).
• Exclusion Criteria:
• • Clients for whom the primary goal of the AFO includes wound management.
• • Those whose AFO is not worn for ambulation.
• • Clients with insensate feet or a history of ulcerations.
• • First-time AFO users.