Clinical trial · Interventional
Iterative Design of Custom Dynamic Orthoses
Iterative Design of Custom Dynamic Orthoses and Comprehensive Design of Musculoskeletal Model
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult ALL | Adult Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Healthy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carbon Fiber Custom Dynamic Orthosis (CDO) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- NoCDO, CDOA, CDOB, CDOC
- description
- Participants will be evaluated without a CDO, then with CDOA, then with CDOB, then with CDOC.
- interventionNames
- Device: Carbon Fiber Custom Dynamic Orthosis (CDO)
- type
- EXPERIMENTAL
- label
- NoCDO, CDOA, CDOC, CDOB
- description
- Participants will be evaluated without a CDO, then with CDOA, then with CDOC, then with CDOB.
- interventionNames
- Device: Carbon Fiber Custom Dynamic Orthosis (CDO)
- type
- EXPERIMENTAL
- label
- NoCDO, CDOB, CDOA, CDOC
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available