Ankle Foot Orthosis Comparative Effect

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.

Conditions

• Foot Injuries and Disorders

Interventions

DEVICE

Reaktiv AFO

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.

DEVICE

PhatBrace AFO

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.

Sponsors & Collaborators

• Minneapolis Veterans Affairs Medical Center

  collaborator FED

• Walter Reed National Military Medical Center

  collaborator FED

• Henry M. Jackson Foundation for the Advancement of Military Medicine

  collaborator OTHER

• Center for Veterans Research and Education

  collaborator OTHER

• University of Delaware

  collaborator OTHER

• Johns Hopkins Bloomberg School of Public Health

  collaborator OTHER

• Jason Wilken

  lead OTHER

Principal Investigators

• Jason M. Wilken, PT, PhD · University of Iowa

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-27

Primary Completion

2023-12-18

Completion

2023-12-18

FDA Device

Yes

Countries

• United States

Study Locations