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

Trial Summary

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}

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.

Research Team

Jason M Wilken, PT, PhD

Principal Investigator

University of Iowa

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.

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

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

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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

Custom Dynamic Orthoses and Physical Therapist Intervention for Bilateral Midfoot Amputation: A Case Report. [2022]

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]

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

Design principles, manufacturing and evaluation techniques of custom dynamic ankle-foot orthoses: a review study. [2023]

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]

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

Influence of custom foot orthoses on venous status: A quasi-experimental study. [2019]

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

Comparative effect of orthosis design on functional performance. [2016]