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Comparing Digitally and Traditionally Made Ankle Foot Orthoses

RecruitingNAAges 8 Years - anyAllHolland Bloorview Kids Rehabilitation Hospital
NCT06828653 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The research is being done to compare two methods of creating AFOs: 1. The traditional method, which involves manually creating a mold from a plaster cast of the client's limb. This is time-consuming and labor-intensive; and 2. The newer method uses digital technology, such as 3D scanning and printing, to design and produce the AFOs, potentially making the process faster and less costly. We want to know whether AFOs made using digital technology can provide the same clinical benefits as those made traditionally.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Part A First Wear Period: Traditional AFO(s)
  • Part A First Wear Period: Digital AFO(s)
  • Part A Second Wear Period: Traditional AFO(s)
  • Part A Second Wear Period: Digital AFO(s)
  • Part B Long-term Evaluation Period: Traditional AFO(s)
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Where

2 sites
Boundless Biomechanical Bracing
Mississauga, Canada
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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