Back to resultsInvestigating Auto Adjusting Dynamic AFO
Primary Purpose
Lower Limb; Fusion, Congenital, Lower Limb Fracture, Ankle Foot Injury
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Variable Stiffness AFO
Sponsored by
About this trial
This is an interventional supportive care trial for Lower Limb; Fusion, Congenital focused on measuring Ankle foot orthotic
Eligibility Criteria
Inclusion Criteria (Healthy Volunteers):
-able to run continuously for 1 minute
Inclusion Criteria (All Other Volunteers)
- Sustained a major unilateral lower-limb injury requiring surgical reconstruction, at least 6-months post-op
- 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
Sites / Locations
- University of Washington, Dept. of BioengineeringRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Aim 2
Aim 3
Arm Description
Participants will carry out a protocol comprised of treadmill walking in a laboratory setting while wearing the Dynamic AFO device.
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.
Outcomes
Primary Outcome Measures
Time Running Per Day
Collected while participant uses device in free-living environment.
Longest Running Bout Duration
Collected while participant uses device in free-living environment.
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.
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.
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.
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.
Extended Figure-of-8 Test
Participants carrying out the in-lab protocol will be asked to do a Figure-of-8 test.
Secondary Outcome Measures
Full Information
NCT ID
NCT04623853
First Posted
November 2, 2020
Last Updated
April 14, 2023
Sponsor
University of Washington
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT04623853
Brief Title
Investigating Auto Adjusting Dynamic AFO
Official Title
Investigating Auto Adjusting Dynamic AFO
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
United States Department of Defense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Limb; Fusion, Congenital, Lower Limb Fracture, Ankle Foot Injury
Keywords
Ankle foot orthotic
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aim 2
Arm Type
Experimental
Arm Description
Participants will carry out a protocol comprised of treadmill walking in a laboratory setting while wearing the Dynamic AFO device.
Arm Title
Aim 3
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Variable Stiffness AFO
Intervention Description
The Dynamic AFO is able to adjust in stiffness depending on activity.
Primary Outcome Measure Information:
Title
Time Running Per Day
Description
Collected while participant uses device in free-living environment.
Time Frame
Calculated across all days of data collection (up to 4 weeks).
Title
Longest Running Bout Duration
Description
Collected while participant uses device in free-living environment.
Time Frame
Across all days of data collection (up to 4 weeks), the longest bout of continuous activity will be identified (minutes).
Title
PROMIS-Fatigue
Description
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.
Time Frame
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.
Title
Pain Score
Description
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.
Time Frame
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.
Title
Orthotic Evaluation Questionnaire (OEQ)
Description
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.
Time Frame
Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete an OEQ.
Title
Running Speed on Treadmill
Description
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.
Time Frame
In-lab testing will occur over the course of up to 2 hours at a time.
Title
Extended Figure-of-8 Test
Description
Participants carrying out the in-lab protocol will be asked to do a Figure-of-8 test.
Time Frame
In-lab testing wil occur over the course of up to 2 hours at a time.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Ballesteros, BS
Phone
206-221-5873
Email
danielb25@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Katheryn Allyn, CPO, LPO
Phone
206-390-0228
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan E Sanders, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington, Dept. of Bioengineering
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Ballesteros
Phone
206-221-5873
12. IPD Sharing Statement
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Investigating Auto Adjusting Dynamic AFO
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