Digital vs Traditional Ankle Foot Orthoses for Muscular Weakness

Recruiting at 1 trial location

Overseen By Gloria Lee, MSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Holland Bloorview Kids Rehabilitation Hospital

Disqualifiers: Wound management, Insensate feet, Ulcerations, First-time AFO users

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods for making ankle-foot orthoses (AFOs), which assist individuals with muscle weakness in their legs to walk better. One method employs the traditional plaster mold technique, while the other utilizes new digital technology, such as 3D printing. The researchers aim to determine if digital AFOs can provide the same benefits as traditional ones, with potentially faster and more cost-effective production. Suitable participants have muscle weakness in their lower limbs due to conditions like cerebral palsy or stroke and already use AFOs to aid independent walking. As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance AFO production and accessibility.

Will I have to stop taking my current medications?

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

What prior data suggests that these methods of creating Ankle Foot Orthoses are safe?

Research has shown that ankle-foot orthoses (AFOs), both digital and traditional, are generally safe for use. Studies examining the impact of AFOs on walking have found them to be well-tolerated, with no major safety concerns reported.

Digital AFOs utilize 3D scanning and printing, offering a quicker and cheaper alternative to traditional methods. Although this approach is newer, no evidence suggests it is less safe than traditional AFOs.

Both types of AFOs aim to help individuals with muscle weakness improve their walking. Overall, AFOs are considered a safe option for managing walking difficulties. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares digital and traditional Ankle Foot Orthoses (AFOs) for addressing muscular weakness. Traditional AFOs are typically custom-made using molds of the patient's foot and ankle, which can be time-consuming and less precise. In contrast, digital AFOs leverage advanced technology for a more personalized fit, potentially improving comfort and effectiveness. By comparing both methods, the trial aims to uncover which approach offers better support and mobility for patients, paving the way for enhanced rehabilitation strategies.

What evidence suggests that digital AFOs are effective for muscular weakness?

Research has shown that ankle-foot orthoses (AFOs) can assist individuals with weak calf muscles by making walking easier and faster. In this trial, participants will use both traditional and digital AFOs. The newer digital AFOs employ 3D scanning and printing, potentially making them quicker and cheaper to produce. While traditional AFOs perform well, studies suggest that digital AFOs might provide similar walking assistance. Early findings indicate that digital methods could offer more precise customization for each person, potentially enhancing comfort and function. Overall, both traditional and digital AFOs hold promise for those needing walking support. ^{1 2 6 7 8}

Who Is on the Research Team?

Jan Andrysek, P.Eng, PhD

Principal Investigator

Bloorview Research Institute

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 am 8 years old or older.

I have muscle weakness in my legs due to a condition like cerebral palsy or stroke.

I can walk on my own, but I may use aids like a cane or walker.

Exclusion Criteria

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

First-time AFO users

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

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?

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+

Citations

1. withpower.com withpower.com/trial/digital-vs-traditional-ankle-foot-orthoses-for-muscular-weakness-73f7b

Digital vs Traditional Ankle Foot Orthoses for Muscular ... 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11593354/

Deep Learning and IoT-Based Ankle–Foot Orthosis for ... This paper proposes a method for managing gait imbalances by integrating the Internet of Things (IoT) and machine learning technologies.

3. researchprotocols.org researchprotocols.org/2024/1/e52365/

Innovative Design and Development of Personalized Ankle ... Background: Ankle-foot orthoses (AFOs) are vital in gait rehabilitation for patients with stroke. · Objective: This nonrandomized trial seeks to ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024029578

Optimizing 3D printed ankle-foot orthoses for patients with ... This study provides valuable insights into the production and optimization of 3D printed AFOs for patients with stroke.

5. mdpi.com mdpi.com/1424-8220/22/17/6596

Research and Development of Ankle–Foot Orthoses This review analyzes the design and development of AFOs from the perspective of improving walking ability and reducing walking EC.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0966636224004764

A predictive simulation study to assess the effect of ankle ... AFOs likely reduce tripping frequency, but may negatively affect balance recovery after tripping due to restriction of the ankle range of motion.

7. mdpi.com mdpi.com/2673-7078/5/3/55

Simulation–Driven Design of Ankle–Foot Orthoses Using ... Results: The results indicated that increased translational stiffness significantly reduced inversion angles to safer levels, though direction–dependent effects ...

8. nsuworks.nova.edu nsuworks.nova.edu/cgi/viewcontent.cgi?article=2688&context=ijahsp

Quantifying AFO Use, Fit, and Function Via Outcome ... The purpose of this exploratory study is to ascertain whether PTs treating IwCVA know of and use these orthotic. OMs targeting the ankle and ...