NCT06828653Recruiting
Comparing Digitally and Traditionally Made Ankle Foot Orthoses
Feasibility RCT Evaluating Digitally and Traditionally Produced Ankle Foot Orthoses for Individuals With Impaired Lower Limb Function
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 3 Feb 2025
- Start date
- 5 Sept 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Diseases
- Stroke
- NCT number
- NCT06828653
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 5 Sept 2025 to the primary completion date, Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Clients with insensate feet or a history of ulcerations.
Other
- Clients for whom the primary goal of the AFO includes wound management.
- Those whose AFO is not worn for ambulation.
- First-time AFO users.
Who the study is looking for
- 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).
Age in the registry: 8 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Boundless Biomechanical Bracing Coordinator of this site? Confirm its status | Mississauga | Canada | Not yet recruiting |
| Holland Bloorview Kids Rehabilitation Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.