Investigating Auto Adjusting Dynamic AFO

Study Overview
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Brief Summary
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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.

Official Title
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Investigating Auto Adjusting Dynamic AFO

Conditions
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Lower Limb; Fusion, Congenital, Lower Limb Fracture, Ankle Foot Injury

Intervention / Treatment
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* Device: Variable Stiffness AFO


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria (All Other Volunteers): Unable to ambulate (walk/run) continuously with AFO for at least 1 minute Unable to sit, stand, or negotiate a step onto lab treadmill

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aim 2<br>Participants will carry out a protocol comprised of treadmill walking in a laboratory setting while wearing the Dynamic AFO device. | Device: Variable Stiffness AFO<br>* The Dynamic AFO is able to adjust in stiffness depending on activity.<br>|
| Experimental: Aim 3<br>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<br>* The Dynamic AFO is able to adjust in stiffness depending on activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankle foot orthotic