NCT06352788 From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
| NCT ID | NCT06352788 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jason Wilken |
| Condition | Foot Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2024-07-02 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2024-07-02 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Between the ages of 18 and 65 * 2 or more years from a traumatic injury below the knee * Ability to be fit with an orthosis * Any of the following: * Weakness of ankle plantarflexors (\<4/5 on manual muscle test) * Limited pain-free ankle motion (dorsiflexion (DF) \<10° or plantarflexion (PF) \<20°) * Mechanical pain with loading to hindfoot/midfoot (\>=4/10 Numerical pain rating scale) * Fusion or candidate for fusion of the ankle or hindfoot * Candidate for amputation secondary to ankle/foot injury and impairment Exclusion Criteria: * Pain greater than 8/10 at rest * Ankle weakness or spasticity as a result of spinal cord injury or central nervous system pathology * Use of an orthosis including the knee * Non-ambulatory * Surgery on study limb anticipated in next 4 months * Medical or psychological conditions that would influence functional testing (e.g., severe traumatic brain injury, stroke, heart disease, vestibular disorder) * Neurologic, musculoskeletal, or other conditions limiting function of the contralateral extremity * Uncorrected visual or hearing impairments * Pregnancy * Non-English speaking * BMI \> 40
Contact & Investigator
Jason M Wilken, PT, PhD
PRINCIPAL INVESTIGATOR
University of Iowa
Frequently Asked Questions
Who can join the NCT06352788 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Foot Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06352788 currently recruiting?
Yes, NCT06352788 is actively recruiting participants. Contact the research team at jason-wilken@uiowa.edu for enrollment information.
Where is the NCT06352788 trial being conducted?
This trial is being conducted at San Diego, United States, Iowa City, United States, Minneapolis, United States, Rochester, United States and 1 additional location.
Who is sponsoring the NCT06352788 clinical trial?
NCT06352788 is sponsored by Jason Wilken. The principal investigator is Jason M Wilken, PT, PhD at University of Iowa. The trial plans to enroll 35 participants.