Custom Orthoses for Leg Injuries

(CDODistract Trial)

Overseen By Kirsten M Anderson, BSE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Iowa

Disqualifiers: Brain injury, Arthritis, Necrosis, 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: 5

Duration: 4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how custom-made leg braces (CDOs), crafted from carbon fiber, affect walking and comfort for individuals with leg injuries. Researchers aim to determine if varying the height between the heel and the brace’s footplate alters weight distribution on the foot. Participants will walk with and without these braces at different heel heights. The trial seeks individuals who have experienced a traumatic hindfoot injury and suffer mechanical pain when bearing weight on their leg. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance mobility solutions for future patients.

Do I have to stop taking 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 orthoses are safe for use in leg injuries?

Studies have shown that custom braces made from carbon fiber, known as dynamic orthoses (CDOs), can enhance walking and leg function after lower leg injuries. These braces reduce stress on joints, potentially lowering the risk of arthritis. Although specific safety data is not available, specialized centers use CDOs, indicating they are generally safe for many patients. The trial tests different heel heights (0cm, 1cm, and 2cm) to assess brace fit, and these variations do not introduce new safety concerns. Overall, CDOs are well-tolerated, with no reports of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Carbon Fiber Custom Dynamic Orthosis (CDO) because it offers a personalized approach to managing leg injuries. Unlike traditional orthoses, which are often generic and inflexible, the CDO's carbon fiber construction allows for a lightweight and dynamic fit, potentially improving mobility and comfort. By experimenting with different heel distraction heights (0cm, 1cm, and 2cm), this treatment aims to optimize support and functionality tailored to individual needs, which could lead to better rehabilitation outcomes compared to standard options.

What evidence suggests that these orthoses could be effective for leg injuries?

Research has shown that Carbon Fiber Custom Dynamic Orthoses (CDOs) can reduce pain and improve leg support. Studies have found that CDOs lower pressure on the front part of the foot compared to walking without support, spreading pressure more evenly and making walking more comfortable. Additionally, CDOs distribute forces around the leg, supporting overall leg function and aiding recovery from injuries. In this trial, participants will be assigned to different groups to test the effectiveness of CDOs with varying heel distraction heights or without a CDO, evaluating their impact on leg injuries. These benefits suggest that CDOs might be a good option for people with leg injuries who want to reduce pain and move more easily. ^{1 3 6 7 8}

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 individuals aged 18-50 with a unilateral leg injury or disease affecting muscles, bones, or nerves. Participants must use a carbon fiber custom dynamic orthosis (CDO), experience mechanical pain when loading the limb (>4/10 on pain scale), walk 50 feet at a slow to moderate pace without support, and be able to read/write in English.

Inclusion Criteria

I can walk without using a cane or crutch.

I experience significant pain (more than 4 out of 10) when putting weight on my limb.

I can walk 50 feet at a slow to moderate pace.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including pain rating and gait analysis without orthoses

1 week

1 visit (in-person)

Treatment

Participants complete study activities with different heel distraction heights using CDOs

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Carbon Fiber Custom Dynamic Orthosis (CDO)

Trial Overview The study examines how different heel distraction heights in CDOs affect foot loading during walking. It aims to understand the impact on limb motion and patient-reported outcomes like pain and comfort compared to unloading ankle foot orthoses (AFOs).

How Is the Trial Designed?

Group I: 2cm Distraction Experimental Treatment 1 Intervention

Participants will complete study activities while wearing a CDO with 2cm of heel distraction height

Group II: 1cm Distraction Experimental Treatment 1 Intervention

Participants will complete study activities while wearing a CDO with 1cm of heel distraction height

Group III: 0cm Distraction Experimental Treatment 1 Intervention

Participants will complete study activities while wearing a CDO with 0cm of heel distraction height

Group IV: NoCDO Active Control 1 Intervention

Participants will complete study activities without a CDO

Carbon Fiber Custom Dynamic Orthosis (CDO) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Carbon Fiber Custom Dynamic Orthosis for:

• Foot drop
• Plantar flexion weakness
• Ankle instability
• Neurological conditions affecting the lower limbs

Approved in European Union as Carbon Fiber Custom Dynamic Orthosis for:

• Foot drop
• Plantar flexion weakness
• Ankle instability
• Neurological conditions affecting the lower limbs

Approved in Canada as Carbon Fiber Custom Dynamic Orthosis for:

• Foot drop
• Plantar flexion weakness
• Ankle instability
• Neurological conditions affecting the lower limbs

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

Fabtech Systems

Collaborator

Trials

3

Recruited

80+

Published Research Related to This Trial

A systematic review of 78 articles found that carbon fiber ankle-foot orthoses (AFOs) are effective in improving outcomes like walking speed, pain reduction, and balance in various patient populations, including those with lower-limb trauma and neurological disorders.

The review identified five commonly used carbon fiber AFO devices, each tailored to specific conditions, highlighting the importance of device design and patient population in achieving favorable results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbon fiber ankle-foot orthoses in impaired populations: A systematic review. Grunst, MM., Wiederien, RC., Wilken, JM.[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]

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]

The study compared traditional ankle-foot orthoses (AFOs) with a new design featuring a dorsal carbon fiber spring in five patients with Spina Bifida, showing that the carbon spring significantly enhances energy return during walking, particularly during the push-off phase (p<0.05).

The use of carbon fiber springs resulted in more natural ankle and knee movements, suggesting improved functionality over classic AFO designs, although careful alignment during fitting is crucial for optimal performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic assist by carbon fiber spring AFOs for patients with myelomeningocele. Wolf, SI., Alimusaj, M., Rettig, O., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30334889/

Multisite Evaluation of a Custom Energy-Storing Carbon ... The current study was designed to determine if results could be replicated at other military treatment facilities and to examine whether early ...

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

Comparative Effect of Carbon Fiber Orthosis Cuff Design ... Carbon fiber custom dynamic orthoses (CDOs) can improve outcomes by reducing pain, supporting the limb, and transferring forces around the limb through the CDO.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38870878/

The effect of carbon fiber custom dynamic orthosis use and ... Commercially available orthoses commonly used to treat limb trauma affect the timing of center of pressure progression relative to walking without an orthosis.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0966636224001309

Foot offloading associated with carbon fiber orthosis use Highlights. •. Compared to walking without an orthosis, peak forefoot forces decreased with carbon fiber custom dynamic orthosis use.

5. withpower.com withpower.com/trial/phase-post-traumatic-osteoarthritis-8-2022-90c84

Carbon Fiber Orthosis for Lower Limb Injury (AFOCUFF Trial) Carbon fiber orthoses, like ankle-foot orthoses (AFOs) and custom dynamic orthoses (CDOs), have been used to reduce pain and improve function in various patient ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04562896

Iterative Design of Custom Dynamic Orthoses to Reduce ... It is expected that carbon fiber braces can be designed to reduce forces in the ankle joint and thereby reduce the risk of developing arthritis following ...

7. amazon.com amazon.com/Lightweight-Hemiplegia-Assistance-Brace-Direct/dp/B09MGCP8X6

Brace Direct Carbon Fiber AFO - Lightweight Dynamic ... How to Wear The Carbon Fiber AFO ; Customizable Fit. Padded straps and adjustable design ensure a secure, personalized fit for users up to 285 lbs. ; Brace Size ...

8. molinahealthcare.com molinahealthcare.com/providers/oh/medicaid/policies/-/media/Molina/PublicWebsite/PDF/Providers/oh/medicaid/policies/MCP-352-Dynamic-Exoskeletal-Orthoses-for-Lower-Extremity-Injuries-1124.pdf

MCP-352-Dynamic-Exoskeletal-Orthoses-for-Lower- ... Return-to-duty rates following lower leg, foot and ankle injuries continue to be remarkably low, with only 18% to 28% returning to duty after ...