NCT06828653 Comparing Digitally and Traditionally Made Ankle Foot Orthoses
| NCT ID | NCT06828653 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Holland Bloorview Kids Rehabilitation Hospital |
| Condition | Flaccid Paresis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-09-05 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-09-05 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Jan Andrysek, P.Eng, PhD
PRINCIPAL INVESTIGATOR
Bloorview Research Institute
Frequently Asked Questions
Who can join the NCT06828653 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, studying Flaccid Paresis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06828653 currently recruiting?
Yes, NCT06828653 is actively recruiting participants. Contact the research team at cngan@hollandbloorview.ca for enrollment information.
Where is the NCT06828653 trial being conducted?
This trial is being conducted at Mississauga, Canada, Toronto, Canada.
Who is sponsoring the NCT06828653 clinical trial?
NCT06828653 is sponsored by Holland Bloorview Kids Rehabilitation Hospital. The principal investigator is Jan Andrysek, P.Eng, PhD at Bloorview Research Institute. The trial plans to enroll 50 participants.