Effects of heel distraction height on foot loading with carbon fiber orthoses
The Effects of Heel Distraction Height on Foot Loading With Carbon Fiber Custom Dynamic Orthoses
NA · University of Iowa · NCT06127316
This study tests how different heel heights in special foot supports can change the way people with lower limb injuries walk and feel during movement.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Iowa (other) |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT06127316 on ClinicalTrials.gov |
What this trial studies
This study investigates how different heel distraction heights in carbon fiber custom dynamic orthoses (CDOs) affect foot loading and motion during walking in individuals with traumatic lower limb injuries. It aims to measure the forces acting under the foot using advanced wireless technology while also assessing patient-reported pain and comfort levels. By comparing the performance of CDOs to unloading ankle foot orthoses (AFOs), the study seeks to understand the biomechanical differences and their implications for rehabilitation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with traumatic hindfoot injuries and moderate mechanical pain during limb loading.
Not a fit: Patients with severe brain injuries, significant functional limitations, or conditions that severely affect mobility may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved orthotic designs that enhance mobility and reduce pain for patients with lower limb injuries.
How similar studies have performed: While there have been studies on the effectiveness of CDOs and AFOs, this specific investigation into heel distraction height is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ages 18-65 years 2. Traumatic hindfoot injury (soft tissue injury or fracture affecting the hindfoot or ankle) 3. Mechanical pain with limb loading (\>=4/10 on Numerical Pain Rating Scale) 4. Ability to walk 50 feet at a slow to moderate pace 5. Ability to walk without a cane or crutch 6. Ability to read and write in English and provide written informed consent Exclusion Criteria: 1. Diagnosis with a moderate or severe brain injury 2. Diagnosis with a physical or psychological condition that would preclude functional testing (e.g., cardiac condition, clotting disorder, pulmonary condition, etc. 3. Ankle weakness resulting from spinal cord injury or central nervous system pathology 4. Nerve, muscle, bone, or other condition limiting function in the contralateral extremity 5. Rheumatoid or inflammatory arthritis 6. Necrosis of any bones in the foot or ankle 7. Pain of 8/10 or greater during walking 8. Uncorrected visual or hearing impairments 9. Require use of a knee stabilizing device to perform daily activities (i.e., Knee ankle foot orthosis, knee orthosis, etc.) 10. Pregnancy 11. Body mass index greater than 40 kg/m2
Where this trial is running
Iowa City, Iowa
- University of Iowa — Iowa City, Iowa, 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: 3193356857
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.
Conditions: Traumatic Lower Limb Injury, Plantar Force, Ankle Foot Orthosis, Carbon Fiber Orthosis, Biomechanics