An interventional study of Variable Stiffness AFO in Lower Limb; Fusion, Congenital, Lower Limb Fracture and Ankle Foot Injury, sponsored by University of Washington. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by University of Washington · Not applicable, Interventional, and Supportive care
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.
51 studies on the registry are indexed under Foot Injuries; 10 are open to participants now.
This study's planned enrollment of 22 is below the median of 52 across 38 interventional studies indexed under Foot Injuries.
Browse Foot Injuries studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (Healthy Volunteers):
-able to run continuously for 1 minute
Inclusion Criteria (All Other Volunteers)
Exclusion Criteria (Healthy Volunteers):
Exclusion Criteria (All Other Volunteers):
Participants will carry out a protocol comprised of treadmill walking in a laboratory setting while wearing the Dynamic AFO device.
Device: Variable Stiffness AFO
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.
Device: Variable Stiffness AFO
The Dynamic AFO is able to adjust in stiffness depending on activity.
Time 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.
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.
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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