Comparing Digitally and Traditionally Made Ankle Foot Orthoses

NCT ID: NCT06828653

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-05
• Study Completion Date: 2027-03-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Part A: Traditional AFO(s) wear first; Part B: Traditional AFO(s) wear

Participants wear traditionally produced AFO(s) for 3 weeks, and will then crossover to wear digital AFO(s) for another 3 weeks. In Part B of the study, participants will wear traditional AFO(s) for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Part A First Wear Period: Traditional AFO(s)

Intervention Type: DEVICE

Participants are randomized to wear traditionally produced AFOs during Weeks 1 through 3.

Part A Second Wear Period: Digital AFO(s)

Intervention Type: DEVICE

Participants wear digitally produced AFOs during Weeks 4 through 6.

Part B Long-term Evaluation Period: Traditional AFO(s)

Intervention Type: DEVICE

Participants are randomized to wear traditionally produced AFO(s) during Weeks 7 through 14.

Part A: Digital AFO(s) wear first; Part B: Digital AFO(s) wear

Participants wear digitally produced AFO(s) for 3 weeks, and will then crossover to wear traditional AFO(s) for another 3 weeks. In Part B of the study, participants will wear digital AFO(s) for 8 weeks.

Group Type: EXPERIMENTAL

Part A First Wear Period: Digital AFO(s)

Intervention Type: DEVICE

Participants are randomized to wear digitally produced AFOs during Weeks 1 through 3.

Part A Second Wear Period: Traditional AFO(s)

Intervention Type: DEVICE

Participants wear traditionally produced AFOs during Weeks 4 through 6.

Part B Long-term Evaluation Period: Digital AFO(s)

Intervention Type: DEVICE

Participants are randomized to wear digitally produced AFO(s) during Weeks 7 through 14.

Part A: Traditional AFO(s) wear first; Part B: Digital AFO(s) wear

Participants wear traditionally produced AFO(s) for 3 weeks, and will then crossover to wear digital AFO(s) for another 3 weeks. In Part B of the study, participants will wear digital AFO(s) for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Part A First Wear Period: Traditional AFO(s)

Intervention Type: DEVICE

Participants are randomized to wear traditionally produced AFOs during Weeks 1 through 3.

Part A Second Wear Period: Digital AFO(s)

Intervention Type: DEVICE

Participants wear digitally produced AFOs during Weeks 4 through 6.

Part B Long-term Evaluation Period: Digital AFO(s)

Intervention Type: DEVICE

Participants are randomized to wear digitally produced AFO(s) during Weeks 7 through 14.

Part A: Digital AFO(s) wear first; Part B: Traditional AFO(s) wear

Participants wear digitally produced AFO(s) for 3 weeks, and will then crossover to wear traditional AFO(s) for another 3 weeks. In Part B of the study, participants will wear traditional AFO(s) for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Part A First Wear Period: Digital AFO(s)

Intervention Type: DEVICE

Participants are randomized to wear digitally produced AFOs during Weeks 1 through 3.

Part A Second Wear Period: Traditional AFO(s)

Intervention Type: DEVICE

Participants wear traditionally produced AFOs during Weeks 4 through 6.

Part B Long-term Evaluation Period: Traditional AFO(s)

Intervention Type: DEVICE

Participants are randomized to wear traditionally produced AFO(s) during Weeks 7 through 14.

Interventions

Part A First Wear Period: Traditional AFO(s)

Participants are randomized to wear traditionally produced AFOs during Weeks 1 through 3.

Intervention Type: DEVICE

Part A First Wear Period: Digital AFO(s)

Participants are randomized to wear digitally produced AFOs during Weeks 1 through 3.

Intervention Type: DEVICE

Part A Second Wear Period: Traditional AFO(s)

Participants wear traditionally produced AFOs during Weeks 4 through 6.

Intervention Type: DEVICE

Part A Second Wear Period: Digital AFO(s)

Participants wear digitally produced AFOs during Weeks 4 through 6.

Intervention Type: DEVICE

Part B Long-term Evaluation Period: Traditional AFO(s)

Participants are randomized to wear traditionally produced AFO(s) during Weeks 7 through 14.

Intervention Type: DEVICE

Part B Long-term Evaluation Period: Digital AFO(s)

Participants are randomized to wear digitally produced AFO(s) during Weeks 7 through 14.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Holland Bloorview Kids Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Andrysek, P.Eng, PhD

Role: PRINCIPAL_INVESTIGATOR

Bloorview Research Institute

Virginia Wright, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Bloorview Research Institute

Locations

Boundless Biomechanical Bracing

Mississauga, Ontario, Canada

Site Status: NOT_YET_RECRUITING

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Calvin Ngan, PhD

Role: CONTACT

cngan@hollandbloorview.ca

416-425-6220 ext. 6340

Gloria Lee, MSc

Role: CONTACT

glee@hollandbloorview.ca

416-425-6220 ext. 3342

Facility Contacts

Anne Whitney, MSc

Role: primary

anne@boundlessbracing.com

905-602-0650

Calvin Ngan, PhD

Role: primary

cngan@hollandbloorview.ca

416-425-6220 ext. 6340

Gloria Lee, MSc

Role: backup

glee@hollandbloorview.ca

416-425-6220 ext. 3342

Other Identifiers

703

Identifier Type: -

Identifier Source: org_study_id