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NCT03901053 · ClinicalTrials.gov registry record · NA
Ankle Foot Orthosis Comparative Effect
A NA study, sponsored by Jason Wilken.
- Completed
- Registry status
- NA
- Development phase
- 54
- Enrollment target
NCT03901053: Completed NA study, sponsored by Jason Wilken.
NCT03901053 is a NA study that has completed, run by Jason Wilken. The registered enrollment target is 54 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03901053, a NA study, has completed, sponsored by Jason Wilken.
- COMPLETED
- Registry status
- NA
- Development phase
- 54 participants
- Enrollment target
Study Summary
The proposed effort is designed to support evidence-based practice and optimal care by evaluating how the form, fit and function of two commercially available carbon fiber custom fit braces (Orthoses) influences outcomes following extremity injury. Early data suggests that custom fit carbon fiber braces can significantly improve function following severe lower leg injuries. The proposed study will provide evidence that can be used by clinicians to guide their practice, including care for service members, veterans and civilians who have experienced a high-energy traumatic injury to their lower leg.
Primary Outcome
The Patient Reported Outcome Information System (PROMIS) physical function Computer Adaptive Test (CAT) is a computerized assessment measuring physical function. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents more of the measured variable than the population average.
Interventions
- DEVICE Reaktiv AFO
- DEVICE PhatBrace AFO
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2020-02-27 |
| Est. Completion | 2023-12-18 |
| Phase | NA |
What the finished NCT03901053 record still lists
NCT03901053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Reaktiv AFO is the first listed.
NCT03901053 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03901053 about?
NCT03901053 is a clinical study titled "Ankle Foot Orthosis Comparative Effect". The proposed effort is designed to support evidence-based practice and optimal care by evaluating how the form, fit and function of two commercially available carbon fiber custom fit braces (Orthoses) influences outcomes following extremity injury. Early data suggests that custom fit carbon fiber br...
What is the current status of trial NCT03901053?
This trial is currently completed. It is a NA study. The enrollment target is 54 participants. The study started on 2020-02-27. Estimated completion is 2023-12-18.
What interventions are being tested in trial NCT03901053?
The interventions under investigation include: Reaktiv AFO (DEVICE), PhatBrace AFO (DEVICE).
Who is sponsoring clinical trial NCT03901053?
This trial is sponsored by Jason Wilken, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03901053's enrollment target sits among peer trials
54 1268th of 2000 higher than 730 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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