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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
22
The Dynamic AFO is able to adjust in stiffness depending on activity.
University of Washington, Dept. of Bioengineering
Seattle, Washington, United States
RECRUITINGTime Running Per Day
Collected while participant uses device in free-living environment.
Time frame: Calculated across all days of data collection (up to 4 weeks).
Longest Running Bout Duration
Collected while participant uses device in free-living environment.
Time frame: Across all days of data collection (up to 4 weeks), the longest bout of continuous activity will be identified (minutes).
PROMIS-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.
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.
Pain Score
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.
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.
Orthotic Evaluation Questionnaire (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.
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Running Speed on Treadmill
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.
Time frame: In-lab testing will occur over the course of up to 2 hours at a time.
Extended Figure-of-8 Test
Participants carrying out the in-lab protocol will be asked to do a Figure-of-8 test.
Time frame: In-lab testing wil occur over the course of up to 2 hours at a time.