50 Participants Needed

Digital vs Traditional Ankle Foot Orthoses for Muscular Weakness

Recruiting at 1 trial location
CN
GL
Overseen ByGloria Lee, MSc
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Holland Bloorview Kids Rehabilitation Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is it safe to use ankle-foot orthoses for muscular weakness?

Research on ankle-foot orthoses (AFOs) for muscular weakness shows they are generally safe for use in humans. Studies have focused on their effects on walking and comfort, with no significant safety concerns reported.12345

How does the treatment Ankle Foot Orthoses differ from other treatments for muscular weakness?

Ankle Foot Orthoses (AFOs) are unique because they provide stability and support to the ankle and foot, which is crucial for people with muscular weakness, especially in the lower legs. Unlike other treatments, AFOs can be customized for individual needs, such as adjusting stiffness to improve walking efficiency, and they offer a non-invasive way to enhance mobility and prevent further muscle deterioration.12678

What data supports the effectiveness of the treatment Ankle Foot Orthoses for muscular weakness?

Research shows that ankle-foot orthoses (AFOs) can help people with calf muscle weakness by reducing the energy needed for walking and increasing walking speed. Specifically, stiffness-optimized AFOs were found to lower walking energy cost by 9.2% and improve walking speed by 5.2% compared to conventional AFOs.125910

Who Is on the Research Team?

JA

Jan Andrysek, P.Eng, PhD

Principal Investigator

Bloorview Research Institute

VW

Virginia Wright, PT, PhD

Principal Investigator

Bloorview Research Institute

Are You a Good Fit for This Trial?

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.
See 3 more

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
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants wear either traditional or digital AFOs for 3 weeks, then crossover to the other type for another 3 weeks

6 weeks
Weekly visits for monitoring and adjustments

Treatment Part B

Participants continue wearing the assigned AFO type for an additional 8 weeks

8 weeks
Bi-weekly visits for monitoring and adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ankle Foot Orthoses
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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: Part A: Digital AFO(s) wear first; Part B: Digital AFO(s) wearExperimental Treatment3 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) wearActive Control3 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) wearActive Control3 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) wearActive Control3 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Holland Bloorview Kids Rehabilitation Hospital

Lead Sponsor

Trials
69
Recruited
14,100+

Citations

Ankle-Foot Orthosis in Duchenne Muscular Dystrophy: A 4 year Experience in a Multidisciplinary Neuromuscular Disorders Clinic. [2018]
Stiffness-Optimized Ankle-Foot Orthoses Improve Walking Energy Cost Compared to Conventional Orthoses in Neuromuscular Disorders: A Prospective Uncontrolled Intervention Study. [2021]
Description of orthotic properties and effect evaluation of ankle-foot orthoses in non-spastic calf muscle weakness. [2020]
The use of stock orthoses to assist gait in neuromuscular disorders: a pilot study. [2015]
The gait and energy efficiency of stance control knee-ankle-foot orthoses: A literature review. [2016]
Immediate and long-term effects of ankle-foot orthosis on muscle activity during walking: a randomized study of patients with unilateral foot drop. [2019]
Design and evaluation of a stance-control knee-ankle-foot orthosis knee joint. [2006]
Effects of AFO use on walking in boys with Duchenne muscular dystrophy: a pilot study. [2014]
Biomechanical and electromyographic evaluation of ankle foot orthosis and dynamic ankle foot orthosis in spastic cerebral palsy. [2022]
Individual stiffness optimization of dorsal leaf spring ankle-foot orthoses in people with calf muscle weakness is superior to standard bodyweight-based recommendations. [2021]
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