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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aim 2 | Experimental | Participants will carry out a protocol comprised of treadmill walking in a laboratory setting while wearing the Dynamic AFO device. |
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| Aim 3 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Variable Stiffness AFO | Device | The Dynamic AFO is able to adjust in stiffness depending on activity. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
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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):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Ballesteros, BS | Contact | 206-221-5873 | danielb25@uw.edu | |
| Katheryn Allyn, CPO, LPO | Contact | 206-390-0228 |
| Name | Affiliation | Role |
|---|---|---|
| Joan E Sanders, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington, Dept. of Bioengineering | Recruiting | Seattle | Washington | 98105 | United States |
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| 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. |