Comparing digitally and traditionally made ankle foot braces in people with movement problems
Compares two ways of making ankle foot braces for people with weak or stiff legs.
Plain-language title generated from the registry record
Registry title: Comparing Digitally and Traditionally Made Ankle Foot Orthoses
Key facts
- Where
- Mississauga and Toronto, CanadaSee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 8 or older with weak or stiff leg muscles from a condition such as cerebral palsy or stroke. They need a custom ankle foot brace (AFO) and can walk on their own.
- Age
- 8 years or older
- Sex
- All sexes can join.
- Disease stage
- Flaccid (weak) or spastic (stiff) paresis from cerebral palsy, stroke, spinal cord injury, spina bifida or traumatic peripheral nerve injury, causing leg movement problems. Must need a custom articulating, rigid, or energy storage and return (ESR) AFO on one or both sides.
- Earlier treatment
- First-time AFO users cannot join, so people must have used an AFO before.
Main reasons for not taking part
- Main goal of the AFO includes wound management
- AFO not worn for walking
- Insensate feet (no feeling) or a history of ulcerations
- First-time AFO user
Read by machine on 12 November 2026.
Where in Canada
- Boundless Biomechanical BracingMississauga, CanadaContact: Anne Whitney, MScNot yet recruiting
- Holland Bloorview Kids Rehabilitation HospitalToronto, CanadaContact: Calvin Ngan, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Holland Bloorview Kids Rehabilitation Hospital
- Trial code
- NCT06828653
- Record updated
- 20 November 2025
- 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.