Custom Orthoses for Leg Injuries

(CDODistract Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jason M Wilken, PT, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Iowa

Disqualifiers: Brain injury, Arthritis, Necrosis, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Carbon fiber custom dynamic orthoses (CDOs) and unloading ankle foot orthoses (AFOs) have shown varying levels of success in reducing forces acting on different regions of the bottom of the foot during gait. CDOs and unloading AFOs have shown differing offloading capabilities across different regions of the foots (hindfoot, midfoot, forefoot) which may be related to a distinct difference between CDOs and unloading AFOs: CDOs do not suspend, or distract, the foot away from the footplate. The purpose of this study is to determine the effects of CDOs and heel distraction height (the distance between the heel and the footplate) on limb loading and motion during gait as well as patient reported pain, and comfort.

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 data supports the effectiveness of the treatment Carbon Fiber Custom Dynamic Orthosis (CDO) for leg injuries?

Research shows that carbon fiber custom dynamic orthoses (CDOs) can reduce pain and improve function, especially in military service members with lower-limb impairments. Additionally, carbon fiber ankle-foot orthoses (AFOs) have been effective in improving mobility and reducing pain in various patient groups. ^{1 2 3 4 5}

Is the use of carbon fiber custom dynamic orthoses (CDOs) generally safe for humans?

Research on carbon fiber custom dynamic orthoses (CDOs) shows they are used to reduce pain and improve function in various patient groups, including military personnel and those with lower-limb impairments. However, specific safety data for civilians is limited, but no significant safety concerns have been reported in the available studies. ^{1 2 3 4 5}

How is the Carbon Fiber Custom Dynamic Orthosis (CDO) treatment different from other treatments for leg injuries?

The Carbon Fiber Custom Dynamic Orthosis (CDO) is unique because it uses carbon fiber to create a lightweight and dynamic support that improves mobility and reduces pain, especially in military service members and individuals with partial foot amputation. Unlike traditional orthoses, the CDO provides enhanced energy return during walking, simulating a natural push-off action. ^{1 2 3 4 5}

Eligibility Criteria

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 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.

I can walk without using a cane or crutch.

Trial Timeline

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

Treatment Details

Interventions

• Carbon Fiber Custom Dynamic Orthosis (CDO) (Orthosis)

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).

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Iowa Iowa City, IA

Who Is Running the Clinical Trial?

University of Iowa Lead Sponsor

Fabtech Systems Collaborator

References

1. 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.

2. 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.

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

Carbon fiber ankle-foot orthoses in impaired populations: A systematic review. [2023] Carbon fiber is increasingly being used in ankle-foot orthoses (AFOs). Orthotic devices and carbon fiber-containing devices have been shown to reduce pain and improve function in multiple patient populations. Although the number of publications and interest in carbon fiber AFOs is growing, a systematic evaluation of their effects is lacking.

4. 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.

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

Dynamic assist by carbon fiber spring AFOs for patients with myelomeningocele. [2022] Patients with calf muscle insufficiency and a calcaneus gait are often dependent on ankle-foot orthoses (AFO). The orthosis is intended to improve walking and posture and should prevent structural deformities. AFOs are often manufactured with a dorsiflexion stop. The design of this type of orthosis has been investigated in several previous studies. In the current study, orthoses with a dorsal carbon fiber spring were compared with the classic design. Five patients with Spina Bifida took part in the current study. All participants underwent a 3D gait analysis including kinematic (VICON infrared cameras) and kinetic (Kistler force plates) data collection. The measurements showed that the carbon spring was able to support the patient during the complete stance phase. It was found that the use of a carbon fiber spring significantly increases the energy return during the 3rd rocker, simulating the natural push-off action (p