20 Participants Needed

Custom Orthoses for Leg Injuries

(CDODistract Trial)

JM
KM
Overseen ByKirsten M Anderson, BSE
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Iowa
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

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.12345

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.12345

Research Team

Jason WILKEN | Director Human ...

Jason M Wilken, PT, PhD

Principal Investigator

University of Iowa

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.
See 3 more

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)
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
4Treatment groups
Experimental Treatment
Active Control
Group I: 2cm DistractionExperimental Treatment1 Intervention
Participants will complete study activities while wearing a CDO with 2cm of heel distraction height
Group II: 1cm DistractionExperimental Treatment1 Intervention
Participants will complete study activities while wearing a CDO with 1cm of heel distraction height
Group III: 0cm DistractionExperimental Treatment1 Intervention
Participants will complete study activities while wearing a CDO with 0cm of heel distraction height
Group IV: NoCDOActive Control1 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:

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Approved in United States as Carbon Fiber Custom Dynamic Orthosis for:
  • Foot drop
  • Plantar flexion weakness
  • Ankle instability
  • Neurological conditions affecting the lower limbs
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Approved in European Union as Carbon Fiber Custom Dynamic Orthosis for:
  • Foot drop
  • Plantar flexion weakness
  • Ankle instability
  • Neurological conditions affecting the lower limbs
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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

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials
486
Recruited
934,000+

Fabtech Systems

Collaborator

Trials
3
Recruited
80+

Findings from Research

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.
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.
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 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.
Carbon fiber ankle-foot orthoses in impaired populations: A systematic review.Grunst, MM., Wiederien, RC., Wilken, JM.[2023]

References

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]
Predictors of long-term pain and function in individuals who received a custom dynamic orthosis and device-centric care pathway. [2023]
Carbon fiber ankle-foot orthoses in impaired populations: A systematic review. [2023]
Custom Dynamic Orthoses and Physical Therapist Intervention for Bilateral Midfoot Amputation: A Case Report. [2022]
Dynamic assist by carbon fiber spring AFOs for patients with myelomeningocele. [2022]
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