Ankle Foot Injury, Lower Limb Fracture, Lower Limb; Fusion, Congenital
Conditions
Keywords
Ankle foot orthotic
Brief summary
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.
Interventions
DEVICEVariable Stiffness AFO
The Dynamic AFO is able to adjust in stiffness depending on activity.
Sponsors
United States Department of Defense
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Running Per Day | Calculated across all days of data collection (up to 4 weeks). | Collected while participant uses device in free-living environment. |
| Longest Running Bout Duration | 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 | 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 | 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) | 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 | 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 | 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. |
Countries
United States
Contacts
Primary ContactDaniel Ballesteros, BS
Backup ContactKatheryn Allyn, CPO, LPO
Outcome results
None listed