MedTrace Logo

Investigating Auto Adjusting Dynamic AFO

NCT04623853 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-04-18

No results posted yet for this study

Summary

Offloading Ankle Foot Orthoses (AFOs) are devices designed for people following lower-limb reconstruction to restore mobility by reducing mechanical loading through the injury site and redistributing it proximally. While they perform well for some users, their current form limits full functional potential and may put joints proximal to the injury at risk of long-term damage. This study is directed toward designing and testing a lightweight, variable stiffness, dynamic brace that can adjust in response to user activity.

Conditions

  • Lower Limb; Fusion, Congenital
  • Lower Limb Fracture
  • Ankle Foot Injury

Interventions

DEVICE

Variable Stiffness AFO

The Dynamic AFO is able to adjust in stiffness depending on activity.

Sponsors & Collaborators

Principal Investigators

  • Joan E Sanders, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2024-09-30
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04623853 on ClinicalTrials.gov