Custom Dynamic Orthoses for Foot Injuries

(AFOSVA Trial)

Recruiting at 4 trial locations

Overseen By Molly S Pacha, MS, ATC, LAT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jason Wilken

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

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to use custom dynamic orthoses (CDOs) for individuals with serious foot or ankle injuries. It will test different configurations of these supportive devices to assess their effectiveness in improving movement and reducing pain. Participants will try multiple setups to determine the most effective option. Those who had a below-the-knee injury more than two years ago and experience issues like ankle weakness or limited movement might be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore personalized solutions for enhancing mobility and comfort.

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 prior data suggests that these custom dynamic orthoses are safe for foot injuries?

Research has shown that carbon fiber custom dynamic orthoses (CDOs) are generally safe for use. In one study, most patients (92.4%) experienced positive outcomes, such as reduced pain and improved support for their injured limb. Another study found that CDOs help by distributing pressure around the limb, enhancing comfort and reducing stress on injured areas.

The available studies did not report any serious side effects or negative reactions, indicating that CDOs are well-tolerated. The trial's "Not Applicable" phase designation means that CDOs are not new and have been used safely in other contexts. This information can reassure participants about their safety in this study as well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Custom Dynamic Orthoses (CDOs) because they offer a personalized approach to treating foot injuries. Unlike traditional orthotic devices that are often static, CDOs can be adjusted to different configurations, allowing for tailored support based on the patient’s specific injury and recovery needs. This dynamic adaptability could lead to improved comfort and effectiveness in promoting healing, potentially reducing recovery time compared to standard rigid orthotics. By experimenting with various configurations, researchers hope to find the most effective combination for each patient, which could revolutionize foot injury treatment.

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

Research has shown that custom dynamic orthoses (CDOs), made from carbon fiber, effectively improve recovery after foot injuries. One study found that 92.4% of patients reported positive results, including better physical function and less pain. This trial will evaluate different configurations of CDOs. Researchers will assess participants without a CDO and then with various CDO configurations. These orthoses help people walk faster and with less effort, especially after injuries like strokes. Advances in these devices have improved walking ability, reduced pain, and enhanced function after injuries to muscles and bones. Overall, most patients experience better mobility and less pain, making CDOs a promising option for treating foot injuries. ^{1 2 4 5 6}

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 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 am a candidate for or have had ankle or hindfoot fusion surgery.

I can be fitted for a brace.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Custom Dynamic 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Jason Wilken

Lead Sponsor

Trials

2

Recruited

90+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Navy Medical Center San Diego

Collaborator

Trials

4

Recruited

480+

Minneapolis Veterans Affairs Medical Center

Collaborator

Trials

77

Recruited

355,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

A study of 131 adults using carbon fiber custom dynamic orthoses (CDOs) showed that most participants experienced significant long-term improvements in pain and physical function, with follow-up occurring an average of 4 years after intervention.

Long-term outcomes were strongly predicted by initial pain levels and short-term functional improvements, indicating that early progress with CDOs and training can lead to sustained benefits.

NCBI (Pubmed)

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. Williamson, JN., Grunst, MM., Lynn, J., et al.[2023]

A 72-year-old man fitted with custom carbon-fiber dynamic ankle-foot orthoses (CDOs) after bilateral transmetatarsal amputation experienced significant improvements in gait biomechanics, including over 40% increases in ankle push-off power and plantarflexor moments after just one week of use.

With additional training from a physical therapist, the patient reported enhanced mobility, confidence, and quality of life, demonstrating that CDOs can effectively support recovery and function in individuals with partial foot amputations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Custom Dynamic Orthoses and Physical Therapist Intervention for Bilateral Midfoot Amputation: A Case Report. Anderson, KM., Evans, RE., Connerly, CE., et al.[2022]

A study involving 20 healthy participants demonstrated that using customized foot orthoses (CFO) significantly improved venous function, as indicated by shorter venous filling times and better ejection fractions.

The results suggest that CFO can enhance venous return in the feet, potentially reducing the risk of foot problems and postural disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of custom foot orthoses on venous status: A quasi-experimental study. López-López, D., Araújo, R., Losa-Iglesias, ME., et al.[2019]

The Intrepid Dynamic Exoskeletal Orthosis (IDEO) significantly improved functional performance in patients with lower extremity trauma compared to other orthotic options and no brace, particularly in agility, power, and speed tests.

After using the IDEO and participating in high-intensity rehabilitation, most patients who initially considered amputation opted for limb salvage instead, indicating the potential of this intervention to positively impact patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effect of orthosis design on functional performance. Patzkowski, JC., Blanck, RV., Owens, JG., et al.[2016]

Custom passive dynamic ankle-foot orthoses (PD-AFOs) are becoming more feasible and effective due to advancements in 3D scanning and additive manufacturing, providing better comfort and improved walking parameters compared to standard AFOs.

Despite their advantages, there is currently no established method to customize the stiffness of PD-AFOs based on the patient's specific level of ankle weakness or functional needs, highlighting a gap in their design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design principles, manufacturing and evaluation techniques of custom dynamic ankle-foot orthoses: a review study. Rogati, G., Caravaggi, P., Leardini, A.[2023]

In a study of 131 adult patients using a carbon fiber custom dynamic orthosis (CDO) combined with training, 92% reported improved physical function and 69% reported reduced maximum pain, indicating high initial effectiveness of the intervention.

The improvement in pain and physical function was significantly influenced by baseline pain levels and patient characteristics such as sex, suggesting that personalized approaches may enhance outcomes.

NCBI (Pubmed)

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. Williamson, JN., Grunst, MM., Lynn, J., et al.[2023]

The custom carbon fiber passive dynamic ankle foot orthosis (PDAFO) significantly reduced forefoot maximal force by 66% and contact pressures by 49% in patients with arthritic foot and ankle conditions, indicating its efficacy in off-loading pressure during walking.

Participants using the PDAFO experienced greater loading on the brace compared to their unbraced foot, suggesting that the device effectively redistributes weight and provides measurable pressure relief for those with mobility difficulties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Passive Dynamic Ankle Foot Orthoses Use in Civilian Patients with Arthritic Conditions of the Foot and Ankle. Feng, J., Weiss, J., Thompson, A., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38064296/

Short-term effect of a carbon fiber custom dynamic orthosis ... Most patients (92.4%) reported a positive initial outcome after intervention as measured using patient-reported and objective measures.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05456295

Comparative Effect of Carbon Fiber Orthosis Cuff Design ... The purpose of this study is to determine the effects of CDO proximal cuff design on patient reported outcomes, limb mechanics and loading, and CDO mechanical ...

3. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-024-01425-7

Customized passive-dynamic ankle–foot orthoses can ... Stiffness-customized PD-AFOs can improve the mechanical cost-of-transport and self-selected walking speed in many individuals post-stroke.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8054777/

Custom Dynamic Orthoses and Physical Therapist ... Recent advances in custom carbon-fiber dynamic ankle-foot orthoses (CDOs) have improved gait, pain, and function following musculoskeletal trauma and can ...

5. researchgate.net researchgate.net/publication/376355997_Short-term_effect_of_a_carbon_fiber_custom_dynamic_orthosis_and_integrated_rehabilitation_on_self-reported_physical_function_pain_speed_and_agility_in_civilians

Short-term effect of a carbon fiber custom dynamic orthosis ... Results A majority of patients reported improved or greatly improved physical function (92%), maximum pain (69%), and typical pain (55%) and experienced ...

6. mayo.edu mayo.edu/research/clinical-trials/cls-20572293

Multi-site Evaluation of Custom Dynamic Orthosis Best ... This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom ...