CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 54 enrolled
Drug / intervention
Reaktiv AFO +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03901053
NCT03901053N/ACompleted

Comparative Effect of Commercially Available Custom Dynamic Orthoses (CDOs)

Jason Wilken·interventional·Posted Apr 3, 2019·Updated Jan 29, 2026

In Brief

A clinical study evaluating Reaktiv AFO and PhatBrace AFO for Foot Injuries and Disorders. Completed, enrolled 54 participants across 3 sites.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 3, 2019
Enrollment StartFeb 27, 2020
Primary CompletionDec 18, 2023
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 7.2 years ago

Interventions

Reaktiv AFOdevice

This device is a carbon fiber ankle foot orthosis (brace) that contacts the foot and lower leg. It consists of a foot plate that is designed to protect the foot, a carbon fiber strut on the back that stores and returns energy, and a cuff that goes below the knee. It has a custom geometry and alignment that is specific to the individual.

PhatBrace AFOdevice

Although lighter and thinner than the Reaktiv it has a similar overall design. The posterior strut is typically longer and the footplate is thinner, more compliant and less customized. Further, the device is formed into a single piece.