Comparing Digitally and Traditionally Made Ankle Foot Orthoses

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.

Conditions

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

Interventions

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.

DEVICE

Part A Second Wear Period: Traditional AFO(s)

Participants wear traditionally produced AFOs during Weeks 4 through 6.

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.

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital

  lead OTHER

Principal Investigators

• Jan Andrysek, P.Eng, PhD · Bloorview Research Institute

• Virginia Wright, PT, PhD · Bloorview Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

8 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-05

Primary Completion

2026-12-31

Completion

2027-03-31

Countries

• Canada

Study Locations