N/A
N=9
Iterative Design of Custom Dynamic Orthoses
Adult ALL · Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04800510 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Joint Contact Stress-Time Exposure — 3.9; 3.5; 4.1; 2.7 MPa-s/gait cycle
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Carbon Fiber Custom Dynamic Orthosis (CDO) (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Iowa
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Joint Contact Stress-Time Exposure |
3.9; 3.5; 4.1; 2.7 | — |
| SECONDARY Ankle Range of Motion |
17.8; 16.0; 16.3; 15.5 | — |
| SECONDARY Peak Ankle Moment |
1.5; 1.5; 1.5; 1.4 | — |
| SECONDARY Peak Ankle Power |
2.9; 1.8; 1.6; 2.4 | — |
| SECONDARY Plantar Force (Total Foot) |
406.5; 415.1; 428.6; 424.7 | — |
| SECONDARY Plantar Force (Forefoot) |
199.0; 165.7; 135.2; 149.9 | — |
| SECONDARY Plantar Force (Midfoot) |
65.4; 83.5; 81.6; 89.9 | — |
| SECONDARY Plantar Force (Hindfoot) |
142.0; 165.9; 211.8; 184.9 | — |
| SECONDARY Four Square Step Test (4SST) |
5.5; 6.1; 6.1; 5.8 | — |
| SECONDARY Sit to Stand 5 Times (STS5) |
7.0; 7.7; 7.4; 7.2 | — |
| SECONDARY Numerical Pain Rating Scale |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY The Orthotics Prosthetics Users' Survey (OPUS) |
3.5; 3.6; 4.0 | — |
| SECONDARY Soleus Muscle Force (N) |
1813.0; 1250.2; 1106.6; 1466.3 | — |
| SECONDARY Gastrocnemius Muscle Force (N) |
1232.6; 1333.9; 1262.3; 1210.5 | — |
| SECONDARY Modified Socket Comfort Score (Comfort) |
6.6; 6.8; 8.0 | — |
| SECONDARY Modified Socket Comfort Score (Smoothness) |
6.6; 6.9; 8.3 | — |
Summary
The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. It is expected that carbon fiber braces can be designed to reduce forces in the ankle. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. The purpose of this study is to refine a pre-existing musculoskeletal model and finalize the procedures for inputting multiple data sources into the model to evaluate ankle articular contact stresses.
Eligibility Criteria
Inclusion Criteria
- Between the ages of 18 and 50
- Shoe size between women's 8 and 13.5 or men's 6.5 and 12
- Healthy individuals without a current complaint of lower extremity pain, spine pain, or medical or neuromusculoskeletal disorders that have limited participation in work or exercise in the last 6 months
- Full active range of motion of the bilateral lower extremities and spine
- Ability to hop without pain
- Ability to perform a full squat without pain
- Ability to read and write in English and provide written informed consent
Exclusion Criteria
- Diagnosed moderate or severe brain injury
- Prior lower extremity injury resulting in surgery or limiting function for greater than 6 weeks
- Diagnosis of a physical or psychological condition that would preclude testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
- Visual or hearing impairment that would interfere with instructions given during testing
- Require an assistive device
- Wounds to the foot or calf that would prevent CDO use
- BMI greater than 35
- Pregnancy - Per participant self-report. Due to the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes, participants will be withdrawn from the study
Data sourced from ClinicalTrials.gov (NCT04800510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.