Investigating Auto Adjusting Dynamic AFO

Lower Limb Fracture Clinical Trial

Official title:

Investigating Auto Adjusting Dynamic AFO

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04623853
• Other study ID #: STUDY00009120
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: University of Washington
• Contact: Daniel Ballesteros, BS
• Phone: 206-221-5873
• Email: danielb25[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: December 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Foot Injury
• Foot Injuries
• Lower Limb Fracture
• Lower Limb; Fusion, Congenital

Intervention

Device:
• Variable Stiffness AFO
The Dynamic AFO is able to adjust in stiffness depending on activity.

Locations

Country	Name	City	State
United States	University of Washington, Dept. of Bioengineering	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Running Per Day	Collected while participant uses device in free-living environment.	Calculated across all days of data collection (up to 4 weeks).
Primary	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).
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.