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Comparing Digitally and Traditionally Made Ankle Foot Orthoses

Key facts

Where
Mississauga és Toronto, KanadaSee the 2 sites

Where in Kanada

  • Boundless Biomechanical BracingMississauga, KanadaToborzás még nem indult
  • Holland Bloorview Kids Rehabilitation HospitalToronto, KanadaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Holland Bloorview Kids Rehabilitation Hospital
Trial code
NCT06828653
Record updated
2025. november 20.
Original description
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.Read full original descriptionShow less

Feasibility RCT Evaluating Digitally and Traditionally Produced Ankle Foot Orthoses for Individuals With Impaired Lower Limb Function

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.

Inclusion: 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: Clients with insensate feet or a history of ulcerations; Clients for whom the primary goal of the AFO includes wound management; Those whose AFO is not worn for ambulation; First-time AFO users.

ClinicalTrials.gov NCT06828653

Építés alatt, nem éles – Comparing Digitally and Traditionally Made Ankle Foot Orthoses (NCT06828653) – Frontlight Research