Ankle Foot Orthoses for Foot Injuries

(AFOCE Trial)

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

54 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two types of custom-fit carbon fiber leg braces to help adults who had serious lower leg injuries and still have trouble moving. The braces are designed to give extra support and make it easier to walk. Researchers will compare how well each brace works by measuring things like balance, speed, and comfort.

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 data supports the effectiveness of the treatment PhatBrace AFO, Reaktiv AFO for foot injuries?

Research shows that ankle-foot orthoses (AFOs) can help improve balance and reduce the risk of falls in people with certain conditions, like after a stroke. Additionally, AFOs have been effective in treating severe ankle sprains, allowing most patients to return to activity without restrictions in a few months. ^{1 2 3 4 5}

How is the PhatBrace AFO, Reaktiv AFO treatment different from other treatments for foot injuries?

The PhatBrace AFO and Reaktiv AFO are unique because they are designed to improve balance and walking ability by providing specific ankle support, which can be particularly beneficial for those with compromised balance or spasticity. Unlike standard treatments, these orthoses may offer tailored stiffness and support to enhance mobility and reduce fall risk. ^{1 6 7 8 9}

Research Team

Jason M. Wilken, PT, PhD

Principal Investigator

University of Iowa

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

The ankle-foot orthosis improves balance and reduces fall risk of chronic spastic hemiparetic patients. [2016]

2. France pubmed.ncbi.nlm.nih.gov

Prescription practices for rigid ankle-foot orthoses among UK orthotists. [2023]

3. United States 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Severe Ankle Sprains. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Ankle-foot orthotic management in neuromuscular disorders: recommendations for future research. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The impact of ankle-foot orthosis stiffness on gait: A systematic literature review. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

The Impact of Ankle-foot Orthoses on Balance in Older Adults: a Scoping Review. [2023]

8. France pubmed.ncbi.nlm.nih.gov

A new model of plastic ankle foot orthosis (FAFO (II)) against spastic foot and genu recurvatum. [2017]

9. France pubmed.ncbi.nlm.nih.gov

Effects of joint alignment and type on mechanical properties of thermoplastic articulated ankle-foot orthosis. [2014]