Evaluating custom dynamic orthoses for foot injuries
From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
This study is testing how different styles of custom foot braces can help adults with long-term injuries recover better and move more easily.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Locations | 5 sites (San Diego, California and 4 other locations) |
| Trial ID | NCT06352788 on ClinicalTrials.gov |
What this trial studies
This study evaluates how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) affect recovery outcomes in adults with traumatic lower extremity injuries. Participants, aged 18 to 65 and experiencing ongoing deficits more than two years post-injury, will be randomized to receive either a modular or monolithic CDO. They will undergo assessments without the orthosis and with the CDO in three configurations to determine the optimal setup for improving mobility and function. Established tests will be utilized to compare the effectiveness of each configuration.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who have experienced a traumatic injury below the knee and have ongoing mobility issues for over two years.
Not a fit: Patients with severe pain at rest, non-ambulatory status, or those requiring imminent surgery on the affected limb may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation strategies for patients with foot injuries, enhancing their mobility and quality of life.
How similar studies have performed: Other studies have shown promise in using custom orthoses for rehabilitation, but this specific evaluation of configurations is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Diego, California and 4 other locations
- Naval Medical Center San Diego - Clinical Biomechanics Laboratory — San Diego, California, United States (Recruiting)
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- Minneapolis VA Health Care System - Motion Analysis Laboratory — Minneapolis, Minnesota, United States (Recruiting)
- Mayo Clinic - Motion Analysis Lab — Rochester, Minnesota, United States (Recruiting)
- Vanderbilt University - Zelik Lab For Biomechanics & Assistive Technology — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Jason M Wilken, PT, PhD — University of Iowa
- Study coordinator: Jason M Wilken, PT, PhD
- Email: jason-wilken@uiowa.edu
- Phone: 319-335-6857
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.