Investigating Auto Adjusting Dynamic AFO

Not Applicable

Recruiting

• Conditions: Lower Limb; Fusion, Congenital; Lower Limb Fracture; Ankle Foot Injury
• Interventions: Device: Variable Stiffness AFO

• Registration Number: NCT04623853
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-10
• Study Start: 2020-11-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18
• Primary Completion: 2024-09-30
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Aim 2	Variable Stiffness AFO	Participants will carry out a protocol comprised of treadmill walking in a laboratory setting while wearing the Dynamic AFO device.
Aim 3	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Washington, Dept. of Bioengineering; 🇺🇸 Seattle, Washington, United States