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Study on Custom Dynamic Orthoses for Lower Leg Injuries

This study is looking at how a special type of brace, called a carbon fiber custom dynamic orthosis (CDO), affects the pressure on the front part of your foot when you walk. We want to see if using this brace, especially with training that includes visual feedback (seeing how much pressure you're putting on your foot), can help reduce forces on your foot. You might be able to join if you are 18-65 years old, have had an injury below the knee that requires a CDO, and meet certain shoe size and ankle movement requirements. The main goal is to measure the peak force and total force on your forefoot at the beginning of the study.

Study design
This interventional study plans to enroll 60 participants. Participants will be randomly assigned to receive training with or without visual feedback on their foot loading.
What's involved
Participants will walk with and without the CDO at different times: after initial fitting, after training with or without visual feedback, and after using the CDO at home. You will also complete questionnaires about pain, quality of life, comfort, satisfaction, and preference.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06710119

Effect of Custom Dynamic Orthoses on Forefoot Loading

Recruiting
NAAges 18–65Interventional
University of Iowa
~60 participants
Updated 2025-12-31 on ClinicalTrials.gov
What's tested:Visual Feedback

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Peak Plantar Force (Forefoot)
Measured over Baseline
+1 more outcome measured

Conditions

Lower Extremity Injuries

Explore related trials

Leg Injury

NCT06710119

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cornerstone Prosthetics and Orthotics

    Everett, Washingtonstudy coordinator listed

    Recruiting

  • University of Iowa

    Iowa City, Iowano site contact published

    Active, not recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Jason M Wilken, PT, PhD
[email protected]
319-335-6857
Email the study team

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Eligibility criteria

Inclusion

Ages: 18-65
Sustained a function limiting injury below the knee, requiring a carbon fiber custom dynamic orthosis
Shoe size between women's 8 and 13.5 or men's 6.5 and 13
Any of the following: weakness of ankle plantarflexors (\<4/5 on MMT), limited pain free ankle motion (DF\<10deg or PF\<20deg), mechanical pain with loading onto hindfoot/midfoot/forefoot (\>4/10 on verbal numeric pain rating scale), ankle or hindfoot fusion, candidate for ankle or hindfoot fusion, candidate for amputation secondary to ankle/foot impairment
Ability to walk 25 feet without using a cane or crutch
Ability to walk at a slow to moderate pace
Able to read and write in English and provide written informed consent

Exclusion

Pain \> 9/10 while walking
Ankle weakness as a result of spinal cord injury or central nervous system pathology
AFO or CDO prescription that includes a knee brace or goes up to thigh
Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, heart condition, clotting disorder, lung condition, stroke, vestibular disorder)
Nerve, muscle, bone, or other condition limiting function of the contralateral extremity
BMI greater than 40
Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing
Pregnancy

What this trial measures

  • Peak Plantar Force (Forefoot)Baseline

    Maximum force (N) collected from the forefoot (distal 40% of sensor) during gait.

  • Plantar Force Impulse (Forefoot)Baseline

    Plantar force impulse (Ns) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase as participants walk.