Investigating Auto Adjusting Dynamic AFO

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 30, 2024

Interventions

  • Device: Variable Stiffness AFO
    • The Dynamic AFO is able to adjust in stiffness depending on activity.

Arms, Groups and Cohorts

  • Experimental: Aim 2
    • Participants will carry out a protocol comprised of treadmill walking in a laboratory setting while wearing the Dynamic AFO device.
  • Experimental: Aim 3
    • Participants will be asked to take the Dynamic AFO home and wear the device for up to 4 weeks. The device will be set in either an adjustment-capable mode, or a “locked” mode that functions similar to their own orthotic–the order in which they are tested will be randomized.

Clinical Trial Outcome Measures

Primary Measures

  • Time Running Per Day
    • Time Frame: Calculated across all days of data collection (up to 4 weeks).
    • Collected while participant uses device in free-living environment.
  • Longest Running Bout Duration
    • Time Frame: Across all days of data collection (up to 4 weeks), the longest bout of continuous activity will be identified (minutes).
    • Collected while participant uses device in free-living environment.
  • PROMIS-Fatigue
    • Time Frame: Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete a questionnaire related to fatigue.
    • Participants will be asked to fill out a questionnaire related to their experience using the variable stiffness AFO out of lab in various test configurations. Each PROMIS-Fatigue question asks participants to rank on a scale from 1 to 5 (categorical options), with higher scores indicating a greater level of fatigue.
  • Pain Score
    • Time Frame: Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete a questionnaire related to pain.
    • Participants will be asked to fill out a questionnaire related to their experience using the variable stiffness AFO out of lab in various test configurations. Each Pain-Score question asks participants to rank on a scale from 1 to 10 (categorical options), with higher scores indicating a greater level of pain.
  • Orthotic Evaluation Questionnaire (OEQ)
    • Time Frame: Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete an OEQ.
    • Similar to the Prosthesis Evaluation Questionnaire (PEQ), the OEQ will ask various questions concerning their experience wearing the variable stiffness AFO. Participants will rate their overall satisfaction, ability to ambulate, the health of their limb, the utility of the device, and their overall well-being after wearing the device.
  • Running Speed on Treadmill
    • Time Frame: In-lab testing will occur over the course of up to 2 hours at a time.
    • Participants carrying out the in-lab protocol will be asked to run using the variable stiffness AFO and running speed will be documented at various time points.
  • Extended Figure-of-8 Test
    • Time Frame: In-lab testing wil occur over the course of up to 2 hours at a time.
    • Participants carrying out the in-lab protocol will be asked to do a Figure-of-8 test.

Participating in This Clinical Trial

Inclusion Criteria (Healthy Volunteers): -able to run continuously for 1 minute Inclusion Criteria (All Other Volunteers)

  • prescribed an offloading Ankle-Foot Orthosis (AFO) for walking/running – Use prescribed offloading AFO at least 20 hours per week – Prescribed AFO strut length of at least 200 mm – Able to run continuously for 1 minute Exclusion Criteria (Healthy Volunteers): – limited sensation in the lower limbs – use an assistive device Exclusion Criteria (All Other Volunteers): – Unable to ambulate (walk/run) continuously with AFO for at least 1 minute – Unable to sit, stand, or negotiate a step onto lab treadmill

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Washington
  • Collaborator
    • United States Department of Defense
  • Provider of Information About this Clinical Study
    • Principal Investigator: Joan Sanders, Professor: Engineering – University of Washington
  • Overall Official(s)
    • Joan E Sanders, PhD, Principal Investigator, University of Washington
  • Overall Contact(s)
    • Daniel Ballesteros, BS, 206-221-5873, danielb25@uw.edu

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