NCT04623853|UnknownFDA Device
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Sponsor study identifier
interventional
22
1 country
1
Study Start
November 30, 2020
Actual (reported)Primary Completion
September 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2, 2020
Actual (reported)November 10, 2020
Actual (reported)November 30, 2020
Actual (reported)September 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Time Running Per Day
Collected while participant uses device in free-living environment.
Calculated across all days of data collection (up to 4 weeks).
Longest Running Bout Duration
Collected while participant uses device in free-living environment.
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.
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 carry out a protocol comprised of treadmill walking in a laboratory setting while wearing the Dynamic AFO device.
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.
The Dynamic AFO is able to adjust in stiffness depending on activity.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Washington, Dept. of Bioengineering
Seattle, Washington, 98105, United States
Joan E Sanders, PhD
University of Washington
First Submitted
November 2, 2020
First Posted
November 10, 2020
Study Start
November 30, 2020
Actual (reported)Primary Completion
September 30, 2024
Estimated (date passed)Comparison of Postoperative Analgesia Between Intravenous Paracetamol and Intranasal Tapentadol
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.
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.
Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete an OEQ.
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.
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.
In-lab testing wil occur over the course of up to 2 hours at a time.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 18, 2023
Record last verified: 2023-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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