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Comparing Digitally and Traditionally Made Ankle Foot Orthoses
Sponsor: Holland Bloorview Kids Rehabilitation Hospital
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.
Official title: Feasibility RCT Evaluating Digitally and Traditionally Produced Ankle Foot Orthoses for Individuals With Impaired Lower Limb Function
Key Details
Gender
All
Age Range
8 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-09-05
Completion Date
2027-03-31
Last Updated
2025-11-20
Healthy Volunteers
No
Conditions
Interventions
Part A First Wear Period: Traditional AFO(s)
Participants are randomized to wear traditionally produced AFOs during Weeks 1 through 3.
Part A First Wear Period: Digital AFO(s)
Participants are randomized to wear digitally produced AFOs during Weeks 1 through 3.
Part A Second Wear Period: Traditional AFO(s)
Participants wear traditionally produced AFOs during Weeks 4 through 6.
Part A Second Wear Period: Digital AFO(s)
Participants wear digitally produced AFOs during Weeks 4 through 6.
Part B Long-term Evaluation Period: Traditional AFO(s)
Participants are randomized to wear traditionally produced AFO(s) during Weeks 7 through 14.
Part B Long-term Evaluation Period: Digital AFO(s)
Participants are randomized to wear digitally produced AFO(s) during Weeks 7 through 14.
Locations (2)
Boundless Biomechanical Bracing
Mississauga, Ontario, Canada
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada