Comparing Digitally and Traditionally Made Ankle Foot Orthoses
Feasibility RCT Evaluating Digitally and Traditionally Produced Ankle Foot Orthoses for Individuals With Impaired Lower Limb Function
Holland Bloorview Kids Rehabilitation Hospital
50 participants
Sep 5, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria4
- 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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Interventions
Participants are randomized to wear traditionally produced AFOs during Weeks 1 through 3.
Participants are randomized to wear digitally produced AFOs during Weeks 1 through 3.
Participants wear traditionally produced AFOs during Weeks 4 through 6.
Participants wear digitally produced AFOs during Weeks 4 through 6.
Participants are randomized to wear traditionally produced AFO(s) during Weeks 7 through 14.
Participants are randomized to wear digitally produced AFO(s) during Weeks 7 through 14.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06828653