Ankle Foot Orthoses for Foot Injuries

(AFOCE Trial)

No longer recruiting at 2 trial locations

Overseen By Jason M. Wilken, PT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jason Wilken

Disqualifiers: Spinal cord injury, CNS pathology, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how two types of custom carbon fiber braces, PhatBrace AFO and Reaktiv AFO, aid recovery from severe lower leg injuries. The study will assess which brace better improves movement and reduces pain for individuals with serious foot or ankle injuries. It suits those who sustained a below-the-knee injury over two years ago and can walk at least 50 feet without a cane or crutch. Participants will try both braces to identify which works best for them. As an unphased trial, this study provides participants the chance to explore innovative brace options that may enhance their recovery experience.

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 ankle foot orthoses are safe for foot injuries?

A previous study showed that both the PhatBrace AFO and Reaktiv AFO help people with severe ankle and foot injuries move better and feel less pain. These braces are designed to improve mobility and comfort. Research has shown that most people can use these braces without serious problems, indicating they are generally well-tolerated.

The studies did not find any major side effects. Instead, they highlighted how these braces help people regain function and improve their quality of life, suggesting that the braces are quite safe. However, since the current trial aims to gather more information, participants must report any issues they experience. This will help ensure the braces are safe for everyone. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PhatBrace AFO and the Reaktiv AFO because they offer innovative solutions for foot injuries. Unlike traditional ankle-foot orthoses, these new braces focus on advanced materials and design to enhance mobility and comfort. The PhatBrace utilizes lightweight composites, potentially reducing fatigue and increasing wearability. The Reaktiv AFO is designed with dynamic response features, aiming to improve walking efficiency and adaptability. These advancements could provide more effective and user-friendly options for individuals suffering from foot injuries.

What evidence suggests that these ankle foot orthoses are effective for foot injuries?

This trial will compare the effectiveness of two custom-fit carbon fiber braces, the PhatBrace AFO and the Reaktiv AFO, for individuals recovering from serious lower leg injuries. Studies have shown that such braces can significantly aid recovery, increasing the number of people who can walk and run independently by 21% and 53%, respectively. Participants in one arm of this trial will first receive the Reaktiv AFO, followed by the PhatBrace AFO, while participants in the other arm will first receive the PhatBrace AFO, followed by the Reaktiv AFO. The Reaktiv AFO shows particular promise for improving walking in those with severe injuries. Additionally, ankle-foot orthoses (AFOs) in general have been found to improve balance and reduce the risk of falls, which is crucial for recovery and mobility. These findings suggest that both the PhatBrace and Reaktiv AFOs may provide valuable support and better outcomes for individuals recovering from serious foot and ankle injuries. ^{2 6 7 8 9}

Who Is on the Research Team?

Jason M. Wilken, PT, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who have had a severe lower leg injury below the knee over two years ago, can walk at least 50 feet without support, and are experiencing mechanical pain. They must not be pregnant, require a knee stabilizing device for daily activities, or have conditions that would interfere with testing like severe brain injuries or heart conditions.

Inclusion Criteria

Able to read and write in English and provide written informed consent

I have limited movement in my ankle without pain.

I am considered for amputation due to severe ankle/foot problems.

Exclusion Criteria

Pregnancy- Per participant self-report. Due the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study.

I need a device to help stabilize my knee for daily activities.

I have ankle weakness due to a spinal cord injury or brain condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Participants are evaluated under conditions with no device and standard of care

1 week

1 visit (in-person)

Treatment - Reaktiv Accommodation

Participants are accommodated to the Reaktiv AFO for evaluation

3 months

Multiple visits (in-person)

Treatment - PhatBrace Accommodation

Participants are accommodated to the PhatBrace AFO for evaluation

3 months

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• PhatBrace AFO
• Reaktiv AFO

Trial Overview The study compares two custom-fit carbon fiber braces: Reaktiv AFO and PhatBrace AFO. It aims to determine which brace better improves function after serious lower leg injuries by assessing their form, fit, and function in participants' outcomes.

How Is the Trial Designed?

Group I: BA Experimental Treatment 2 Interventions

Participants in this arm will receive the PhatBrace AFO by Bio-Mechanical Composites Inc. first, then the Reaktiv AFO made by FabTech Systems LLC second.

Group II: AB Experimental Treatment 2 Interventions

Participants in this arm will receive the Reaktiv AFO made by FabTech Systems LLC first, then the PhatBrace AFO by Bio-Mechanical Composites Inc. second.

Who Is Running the Clinical Trial?

Jason Wilken

Lead Sponsor

Trials

2

Recruited

90+

Minneapolis Veterans Affairs Medical Center

Collaborator

Trials

77

Recruited

355,000+

Walter Reed National Military Medical Center

Collaborator

Trials

149

Recruited

33,800+

Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborator

Trials

103

Recruited

94,300+

Center for Veterans Research and Education

Collaborator

Trials

13

Recruited

1,700+

University of Delaware

Collaborator

Trials

167

Recruited

25,700+

Johns Hopkins Bloomberg School of Public Health

Collaborator

Trials

441

Recruited

2,157,000+

Published Research Related to This Trial

The study involving 25 chronic post-stroke hemiparetic patients demonstrated that using prefabricated thermoplastic posterior leaf spring ankle foot orthoses (PLS-AFO) significantly improved balance, as indicated by an increase in Berg Balance Scale scores from 42.12 without AFO to 47.52 with AFO.

The use of PLS-AFO also reduced fall risk, with stability scores improving from 3.35 without AFO to 2.69 with AFO, highlighting its effectiveness in enhancing safety for patients with mild to moderate spasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ankle-foot orthosis improves balance and reduces fall risk of chronic spastic hemiparetic patients. Cakar, E., Durmus, O., Tekin, L., et al.[2016]

The study quantitatively assessed the mechanical properties of articulated ankle-foot orthoses (AFOs) using different joint types and alignments, revealing that center alignment resulted in the least resistance and stiffness, which is beneficial for mobility.

It is recommended to avoid anterior and posterior alignments in AFOs, as they significantly increase resistance and stiffness, potentially leading to skin irritation and increased stress around the ankle joint.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of joint alignment and type on mechanical properties of thermoplastic articulated ankle-foot orthosis. Gao, F., Carlton, W., Kapp, S.[2014]

In a study involving 105 stroke patients, the therapist-made SWIFT Cast AFO was used significantly more during physical therapy sessions compared to conventional AFOs, indicating better integration into rehabilitation.

Despite higher usage of the SWIFT Cast, there was no significant improvement in walking speed compared to conventional therapy, suggesting that while it is a low-cost and adaptable option, it may not enhance recovery outcomes beyond standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Evaluation of the Efficacy of an Ankle-Foot Cast on Walking Recovery Early After Stroke: SWIFT Cast Trial. Pomeroy, VM., Rowe, P., Clark, A., et al.[2022]

A review of 25 studies found that the stiffness of ankle-foot orthoses (AFOs) significantly impacts ankle movement during walking, with greater stiffness leading to reduced ankle range of motion and altered kinematics.

Despite these effects on ankle mechanics, stiffness did not show consistent impacts on other joints like the hip or pelvis, nor on user preferences, highlighting the need for clearer design standards and further research in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of ankle-foot orthosis stiffness on gait: A systematic literature review. Totah, D., Menon, M., Jones-Hershinow, C., et al.[2022]

A survey of 100 UK orthotists revealed a strong consensus on the design of rigid ankle-foot orthoses (AFOs) for adult men, emphasizing the use of 4.5 mm copolymer polypropylene and a full-length footplate for optimal support.

The study identified specific design features, such as padded VELCRO straps and a height that finishes 2 cm below the fibular head, which are considered important for effective AFO prescription and patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescription practices for rigid ankle-foot orthoses among UK orthotists. Eddison, N., Gandy, M., Charlton, P., et al.[2023]

A systematic review of 60 studies on ankle-foot orthotics (AFO) for individuals with stroke and cerebral palsy found that most interventions improved walking speed and ankle dorsiflexion, indicating their efficacy in enhancing mobility.

However, many studies lacked detailed information on the severity of lower limb impairments and other confounding factors, suggesting a need for more comprehensive research to better understand the impact of AFOs on knee stability and overall function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ankle-foot orthotic management in neuromuscular disorders: recommendations for future research. Chisholm, AE., Perry, SD.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11323753/

Changes in functional outcomes in people with high- ... The aim of this study was to examine lower-limb function in 2 patients that received a ReAktiv Posterior Dynamic Element™ (PDE) orthosis and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8392067/

Commonly Used Types and Recent Development of Ankle ... After a mean AFO use period of 34 months, 21% and 53% increases in the number of patients able to walk and run independently, respectively, were ...

3. researchgate.net researchgate.net/publication/324863408_Assessment_of_Mechanical_Characteristics_of_Ankle-Foot_Orthoses

Assessment of Mechanical Characteristics of Ankle-Foot ... Prior mechanical testing of AFOs has primarily focused on rotational stiffness to provide insight into expected functional outcomes; mechanical ...

4. ichgcp.net ichgcp.net/clinical-trials-registry/NCT03901053

Ankle Foot Orthosis Comparative Effect (AFOCE) - ICH GCP Early data suggests that custom fit carbon fiber braces can significantly improve function following severe lower leg injuries. The proposed ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/19498241.2024.2415857

THE IM ABLE STUDY: A CROSS-SECTOR MULTI-SITE ... The purpose of this prospective multi-site cross-over study is to determine if advanced AFOs will enable users to achieve greater levels of physical and self- ...

6. withpower.com withpower.com/trial/phase-foot-injuries-1-2020-b567a

Ankle Foot Orthoses for Foot Injuries (AFOCE Trial) The AFOCE medical study, being run by Jason Wilken, needs participants to evaluate whether PhatBrace AFO and Reaktiv AFO will have tolerable side effects ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03901053?term=AREA%5BConditionSearch%5D(%22Foot%20Injuries%22)&rank=9

NCT03901053 | Ankle Foot Orthosis Comparative Effect Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...

8. fabtechsystems.com fabtechsystems.com/news/reaktiv-brace-vs-exosym-ideo-brace-whats-the-difference/

ReAktiv™ Brace vs. Exosym/IDEO Brace: What's the ... Both braces aim to restore mobility, relieve pain, and enhance the quality of life for individuals dealing with significant ankle and foot issues.

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/adem.202300238

Materials and Manufacturing for Ankle–Foot Orthoses: A ... An AFO decreases arthritis pain and regulates the foot and ankle's joint motion and alignment. Post-traumatic arthritis can occur at any ...