Digital vs Traditional Ankle Foot Orthoses for Muscular Weakness

Recruiting at1 trial location

Overseen by Virginia Wright, PT, PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Holland Bloorview Kids Rehabilitation Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jan Andrysek, P.Eng, PhD

Principal Investigator

Bloorview Research Institute

Virginia Wright, PT, PhD

Principal Investigator

Bloorview Research Institute

Eligibility Criteria

This trial is for individuals with conditions like muscular weakness, spinal cord injury, cerebral palsy, peripheral neuropathy, and similar nerve or muscle issues. It's also for those who have experienced delayed wound healing after a stroke or have nerve damage from injuries.

Inclusion Criteria

I can complete questionnaires with minimal help.

Participants must meet the requirements to have their AFO funded by the Assistive Devices Program (ADP)

I am 8 years old or older.

Exclusion Criteria

Clients for whom the primary goal of the AFO includes wound management

I have lost feeling in my feet or have had foot ulcers before.

First-time AFO users

Treatment Details

Interventions

• Ankle Foot Orthoses (Orthosis)

Trial Overview The study compares ankle foot orthoses (AFOs) made traditionally by hand-casting to those created using digital methods like 3D scanning and printing. Participants will wear both types of AFOs in different periods to assess their effectiveness.

Participant Groups

Group I: Part A: Digital AFO(s) wear first; Part B: Digital AFO(s) wear Experimental Treatment 3 Interventions

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 II: Part A: Traditional AFO(s) wear first; Part B: Traditional AFO(s) wear Active Control 3 Interventions

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 III: Part A: Traditional AFO(s) wear first; Part B: Digital AFO(s) wear Active Control 3 Interventions

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 IV: Part A: Digital AFO(s) wear first; Part B: Traditional AFO(s) wear Active Control 3 Interventions

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.

Who Is Running the Clinical Trial?

Holland Bloorview Kids Rehabilitation Hospital

Lead Sponsor

Trials

69

Recruited

14,100+

Julia Hanigsberg

Holland Bloorview Kids Rehabilitation Hospital

Chief Executive Officer since 2015

Law degrees from McGill University and Columbia Law School

Dr. Golda Milo-Manson

Holland Bloorview Kids Rehabilitation Hospital

Chief Medical Officer since 2010

MD from University of Toronto