Comparing Digitally and Traditionally Made Ankle Foot Orthoses

November 18, 2025 updated by: Holland Bloorview Kids Rehabilitation Hospital

Feasibility RCT Evaluating Digitally and Traditionally Produced Ankle Foot Orthoses for Individuals With Impaired Lower Limb Function

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, L4W5A8
        • Not yet recruiting
        • Boundless Biomechanical Bracing
        • Contact:
      • Toronto, Ontario, Canada, M4G1R8
        • Recruiting
        • Holland Bloorview Kids Rehabilitation Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jan Andrysek, P.Eng, PhD
        • Principal Investigator:
          • Virginia Wright, PT, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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 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.
Experimental: 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.
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 B Long-term Evaluation Period: Digital AFO(s)
Participants are randomized to wear digitally produced AFO(s) during Weeks 7 through 14.
Active Comparator: 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.
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 Second Wear Period: Digital AFO(s)
Participants wear digitally produced AFOs during Weeks 4 through 6.
Device: Part B Long-term Evaluation Period: Digital AFO(s)
Participants are randomized to wear digitally produced AFO(s) during Weeks 7 through 14.
Active Comparator: 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.
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
Time Frame: From the shape capture visit until the end of the study at week 14
Evaluates patient satisfaction related to assistive technology and services rendered. This questionnaire is commonly used in assessing performance of AFOs and other orthotic devices.
From the shape capture visit until the end of the study at week 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Orthotic Patient-Reported Outcomes - Mobility (OPRO-M)
Time Frame: From Week 1 until Week 6 of the study
Designed and validated to assess orthotic users' ability to perform activities related to movement, locomotion, and/or postural transitions.
From Week 1 until Week 6 of the study
Orthotics Prosthetics User's Survey (OPUS)
Time Frame: From Week 1 until Week 6 of the study
Assesses function, satisfaction, and quality of life of individuals using orthotic or prosthetic devices. Its Lower Extremity Functional Status component will be used since it pertains specifically to the individual's functional abilities and limitations.
From Week 1 until Week 6 of the study
10-metre Walk Test
Time Frame: From the shape capture visit until the end of the study at Week 14
Timed walk test
From the shape capture visit until the end of the study at Week 14
Timed Up and Go (TUG)
Time Frame: From the shape capture visit until the end of the study at Week 14
From the shape capture visit until the end of the study at Week 14
Goal Attainment Scale (GAS)
Time Frame: From the shape capture appointment until the participant receives their devices at Week 1
Creating biomechanical (alignment/dynamic) goals that AFOs are designed to treat. Will be applied to both types of AFOs. Goal achievement rating will be based on a modification of the GAS 5-level rating system (levels -2 to 0 only) after AFO fitting is complete
From the shape capture appointment until the participant receives their devices at Week 1
AFO Challenge
Time Frame: From the shape capture visit until the end of the study at Week 14
A new six-item measure that was created by the Holland Bloorview team for this study to capture any functionally important differences in balance linked with AFO type across a spectrum of client abilities.
From the shape capture visit until the end of the study at Week 14
Orthotist Satisfaction Questionnaire
Time Frame: From the shape capture visit until the end of the crossover period at Week 6
Evaluate orthotists' satisfaction with the AFO fabrication and fitting process.
From the shape capture visit until the end of the crossover period at Week 6
Orthotic Patient-Reported Outcomes - Mobility (OPRO-M)
Time Frame: From the shape capture visit until the end of the crossover period at Week 6
Designed and validated to assess orthotic users' ability to perform activities related to movement, locomotion, and/or postural transitions.
From the shape capture visit until the end of the crossover period at Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Holland Bloorview Kids Rehabilitation Hospital

Investigators

  • Principal Investigator: Jan Andrysek, P.Eng, PhD, Bloorview Research Institute
  • Principal Investigator: Virginia Wright, PT, PhD, Bloorview Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

February 14, 2025

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 703

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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