NCT06828653

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Holland Bloorview Kids Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is designed to compare two methods of creating ankle-foot orthoses (AFOs), which are devices used to support the lower limbs in people with mobility impairments due to conditions like stroke or cerebral palsy. The traditional method involves manually creating a mold from a plaster cast of the patient's limb, which is time-consuming and labor-intensive. The new method uses digital technology, such as 3D scanning and printing, to design and produce the AFOs, potentially making the process faster and less costly. The purpose of the study is to test whether AFOs made using digital technology can provide the same clinical benefits as those made traditionally, but with greater efficiency and at a lower cost. The research will gather data on patient satisfaction, the functionality of the AFOs, and the costs associated with each method. This will help determine if the digital method can be a viable alternative to traditional AFO production, potentially leading to better patient care and reduced healthcare costs. The study poses the overarching research question: Can digitally produced ankle-foot orthoses (AFOs) achieve similar positive clinical outcomes to traditionally fabricated AFOs while being more efficient and cost-effective? The primary objective of this feasibility study is to inform the design of a larger randomized controlled trial (RCT) that will comprehensively address this question.

Conditions

• Flaccid Paresis
• Spastic Paresis
• Cerebral Palsy
• Stroke
• Spinal Cord Injury
• Spina Bifida
• Traumatic Peripheral Nerve Injury

Interventions

Type	Name	Description
DEVICE	Part A First Wear Period: Traditional AFO(s)	Participants are randomized to wear traditionally produced AFOs during Weeks 1 through 3.
DEVICE	Part A First Wear Period: Digital AFO(s)	Participants are randomized to wear digitally produced AFOs during Weeks 1 through 3.
DEVICE	Part A Second Wear Period: Traditional AFO(s)	Participants wear traditionally produced AFOs during Weeks 4 through 6.
DEVICE	Part A Second Wear Period: Digital AFO(s)	Participants wear digitally produced AFOs during Weeks 4 through 6.
DEVICE	Part B Long-term Evaluation Period: Traditional AFO(s)	Participants are randomized to wear traditionally produced AFO(s) during Weeks 7 through 14.
DEVICE	Part B Long-term Evaluation Period: Digital AFO(s)	Participants are randomized to wear digitally produced AFO(s) during Weeks 7 through 14.

Timeline

• Start date: 2025-09-05
• Primary completion: 2026-12-01
• Completion: 2027-03-31
• First posted: 2025-02-14
• Last updated: 2025-11-20

Locations

2 sites across 1 country: Canada