Actively Recruiting

Phase Not Applicable
Age: 8Years +
All Genders
NCT06828653

Comparing Digitally and Traditionally Made Ankle Foot Orthoses

Led by Holland Bloorview Kids Rehabilitation Hospital · Updated on 2025-11-20

50

Participants Needed

2

Research Sites

81 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Comparing Digitally and Traditionally Made Ankle Foot Orthoses

Who Can Participate

Age: 8Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be aged 8 years or older.
  • Participants should have flaccid or spastic paresis due to cerebral palsy, stroke, spinal cord injury, spina bifida, or traumatic peripheral nerve injury causing 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.
  • Participants must be able to walk independently, with or without gait aids.
  • Participants must be able to complete questionnaires with no more than orienting guidance.
  • Participants must qualify for Assistive Devices Program (ADP) funding for their AFO.
Not Eligible

You will not qualify if you...

  • Individuals whose primary AFO goal includes wound management.
  • Individuals who do not wear an AFO for walking.
  • Individuals with insensate feet or a history of foot ulcers.
  • First-time AFO users.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Boundless Biomechanical Bracing

Mississauga, Ontario, Canada, L4W5A8

Not Yet Recruiting

2

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, Canada, M4G1R8

Actively Recruiting

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Research Team

C

Calvin Ngan, PhD

CONTACT

G

Gloria Lee, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

4

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