Custom Dynamic Orthoses for Foot Injuries

(AFOSVA Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Jason M Wilken, PT, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Jason Wilken

Disqualifiers: Spinal cord injury, Stroke, Heart disease, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influences outcomes following traumatic lower extremity injury.

Do I need to stop my current medications for the trial?

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

What data supports the effectiveness of the treatment Custom Dynamic Orthosis for foot injuries?

Research shows that custom dynamic orthoses, particularly those made from carbon fiber, can reduce pain and improve function in military service members with lower-limb impairments. Additionally, these orthoses have been beneficial in improving gait, pain, and function for individuals with partial foot amputation and have shown promise in civilian settings for enhancing physical function and reducing pain. ^{1 2 3 4 5}

Is the use of custom dynamic orthoses generally safe for humans?

Custom dynamic orthoses, particularly those made from carbon fiber, have been used to improve mobility and reduce pain in both military and civilian settings. While specific safety data is limited, these devices have been associated with positive outcomes in terms of pain reduction and improved function, suggesting they are generally safe for use. ^{1 2 3 5 6}

How is the Custom Dynamic Orthosis treatment different from other treatments for foot injuries?

The Custom Dynamic Orthosis (CDO) is unique because it is a carbon fiber brace designed to improve mobility and reduce pain by storing and releasing energy, which is particularly beneficial for those with lower-limb impairments or partial foot amputations. Unlike standard braces, CDOs are custom-made and often used with integrated physical training and psychosocial interventions to enhance outcomes. ^{1 2 3 5 7}

Eligibility Criteria

This trial is for adults aged 18-65 who are at least two years post a traumatic injury below the knee, have weak ankle muscles, can be fitted with an orthosis, and experience pain or limited motion in their ankle. It's not suitable for those outside this age range or with conditions that would prevent them from using the orthosis.

Inclusion Criteria

I can be fitted for a brace.

I have weakness in my ankle when trying to push down.

It has been over 2 years since I had a traumatic injury below my knee.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Participants are evaluated without a CDO and with the CDO in three configurations in a randomized order

4-6 weeks

Multiple visits for configuration testing

Treatment

Participants are fitted with either modular or monolithic CDO and undergo various tests to compare outcomes

6 weeks

3 visits (in-person) for each configuration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Custom Dynamic Orthosis (Orthosis)

Trial Overview The study compares two types of carbon fiber custom dynamic orthoses (CDOs) - modular and mono designs - to see which one better improves outcomes after lower extremity injuries.

Participant Groups

Group I: NoCDO, C, B, A Experimental Treatment 2 Interventions

Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration C, CDO configuration B, and finally CDO configuration A.

Group II: NoCDO, C, A, B Experimental Treatment 2 Interventions

Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration C, CDO configuration A, and finally CDO configuration B.

Group III: NoCDO, B, C, A Experimental Treatment 2 Interventions

Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration B, CDO configuration C, and finally CDO configuration A.

Group IV: NoCDO, B, A, C Experimental Treatment 2 Interventions

Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration B, CDO configuration A, and finally CDO configuration C.

Group V: NoCDO, A, C, B Experimental Treatment 2 Interventions

Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration A, CDO configuration C, and finally CDO configuration B.

Group VI: NoCDO, A, B, C Experimental Treatment 2 Interventions

Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration A, CDO configuration B, and finally CDO configuration C.

Custom Dynamic Orthosis is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Custom Dynamic Orthosis for:

• Traumatic lower extremity injury
• Musculoskeletal disorders
• Neurological conditions

🇪🇺 Approved in European Union as Dynamic Orthosis for:

• Lower limb injuries
• Muscle weakness
• Paralysis

🇨🇦 Approved in Canada as Carbon Fiber Orthosis for:

• Orthopedic conditions
• Rehabilitation post-surgery
• Neurological rehabilitation

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Naval Medical Center San Diego - Clinical Biomechanics Laboratory San Diego, CA

University of Iowa Iowa City, IA

Minneapolis VA Health Care System - Motion Analysis Laboratory Minneapolis, MN

Mayo Clinic - Motion Analysis Lab Rochester, MN

More Trial Locations

Who Is Running the Clinical Trial?

Jason Wilken Lead Sponsor

Mayo Clinic Collaborator

Vanderbilt University Medical Center Collaborator

Navy Medical Center San Diego Collaborator

Minneapolis Veterans Affairs Medical Center Collaborator

Johns Hopkins University Collaborator

References

1. France pubmed.ncbi.nlm.nih.gov

Predictors of long-term pain and function in individuals who received a custom dynamic orthosis and device-centric care pathway. [2023] Carbon fiber custom dynamic orthoses (CDOs) have been shown to effectively reduce pain and improve function in military service members with lower-limb impairment, but data are limited for civilians.

2. United States pubmed.ncbi.nlm.nih.gov

Custom Dynamic Orthoses and Physical Therapist Intervention for Bilateral Midfoot Amputation: A Case Report. [2022] Partial foot amputation is often associated with decreased mobility and function. Recent advances in custom carbon-fiber dynamic ankle-foot orthoses (CDOs) have improved gait, pain, and function following musculoskeletal trauma and can benefit individuals with partial foot amputation. However, limited information is available related to CDO use outside the military. The purpose of this case report is to describe the course of care and outcomes of a civilian provided with CDOs after bilateral transmetatarsal amputation.

3. France pubmed.ncbi.nlm.nih.gov

Short-term effect of a carbon fiber custom dynamic orthosis and integrated rehabilitation on self-reported physical function, pain, speed, and agility in civilians. [2023] Ankle-foot orthoses (AFOs) are widely used to restore mobility and reduce pain in individuals with lower extremity pain and disability. The use of a carbon fiber custom dynamic orthosis (CDO) with integrated physical training and psychosocial intervention has been shown to improve outcomes in a military setting, but civilian data are limited.

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

Design principles, manufacturing and evaluation techniques of custom dynamic ankle-foot orthoses: a review study. [2023] Ankle-Foot Orthoses (AFO) can be prescribed to allow drop-foot patients to restore a quasi-normal gait pattern. Standard off-the-shelf AFOs are cost-effective solutions to treat most patients with foot and ankle weakness, but these devices have several limitations, especially in terms of comfort. Therefore, custom AFOs are increasingly adopted to address drop-foot when standard solutions are not adequate. While the solid ones are the most common type of AFO, providing full stability and strong resistance to ankle plantarflexion, passive dynamic AFOs (PD-AFOs) represent the ideal solution for patients with less severe ankle weakness. PD-AFOs have a flexible calf shell, which can bend during the stance phase of walking and absorb energy that can be released to support the limb in the push-off phase. The aim of this review is to assess the state-of-the-art and identify the current limitations of PD-AFOs. An extensive literature review was performed in Google Scholar to identify all studies on custom PD-AFOs. Only those papers reporting on custom PD-AFOs were included in the review. Non peer-reviewed papers, abstract shorter than three pages, lecture notes and thesis dissertations were excluded from the analysis. Particular attention was given to the customization principles and the mechanical and functional tests. For each topic, the main results from all relevant papers are reported and summarized herein. There were 75 papers that corresponded to the search criteria. These were grouped according to the following macro-topics: 16 focusing on scanning technologies and geometry acquisition; 14 on customization criteria; 19 on production techniques; 16 on mechanical testing, and 33 on functional testing. According to the present review, design and production of custom PD-AFOs are becoming increasingly feasible due to advancements in 3D scanning techniques and additive manufacturing. In general, custom PD-AFOs were shown to provide better comfort and improved spatio-temporal parameters with respect to standard solutions. However, no customization principle to adapt PD-AFO stiffness to the patient's degree of ankle impairment or mechanical/functional demand has thus far been proposed.

5. United States pubmed.ncbi.nlm.nih.gov

Passive Dynamic Ankle Foot Orthoses Use in Civilian Patients with Arthritic Conditions of the Foot and Ankle. [2023] Nonsurgical interventions such as bracing with ankle foot orthoses (AFOs) aim to assist, restore, and redirect weightbearing forces to address difficulty with mobilization. We identified a custom carbon fiber passive dynamic ankle foot orthosis (PDAFO) that was designed to meet the needs of military combat veterans. We sought to evaluate the off-loading properties of one model of PDAFO (ExoSym) in a civilian population.

6. Netherlands pubmed.ncbi.nlm.nih.gov

Influence of custom foot orthoses on venous status: A quasi-experimental study. [2019] Customized foot orthoses (CFO) have been widely accepted to reduce the frequency of foot problems and postural disorders. The purpose of the research was to compare the influence of CFO utilization on the venous status among healthy females and males.

7. United States pubmed.ncbi.nlm.nih.gov

Comparative effect of orthosis design on functional performance. [2016] High-energy extremity trauma is common in combat. Orthotic options for patients whose lower extremities have been salvaged are limited. A custom energy-storing ankle-foot orthosis, the Intrepid Dynamic Exoskeletal Orthosis (IDEO), was created and used with high-intensity rehabilitation as part of the Return to Run clinical pathway. We hypothesized that the IDEO would improve functional performance compared with a non-custom carbon fiber orthosis (BlueRocker), a posterior leaf spring orthosis, and no brace.