- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04623853
Investigating Auto Adjusting Dynamic AFO
April 14, 2023 updated by: Joan Sanders, University of Washington
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Daniel Ballesteros, BS
- Phone Number: 206-221-5873
- Email: danielb25@uw.edu
Study Contact Backup
- Name: Katheryn Allyn, CPO, LPO
- Phone Number: 206-390-0228
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98105
- Recruiting
- University of Washington, Dept. of Bioengineering
-
Contact:
- Daniel Ballesteros
- Phone Number: 206-221-5873
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aim 2
Participants will carry out a protocol comprised of treadmill walking in a laboratory setting while wearing the Dynamic AFO device.
|
The Dynamic AFO is able to adjust in stiffness depending on activity.
|
Experimental: Aim 3
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.
|
The Dynamic AFO is able to adjust in stiffness depending on activity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time Running Per Day
Time Frame: Calculated across all days of data collection (up to 4 weeks).
|
Collected while participant uses device in free-living environment.
|
Calculated across all days of data collection (up to 4 weeks).
|
Longest Running Bout Duration
Time Frame: 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.
|
Across all days of data collection (up to 4 weeks), the longest bout of continuous activity will be identified (minutes).
|
PROMIS-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.
|
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
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.
|
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)
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.
|
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
Time Frame: 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.
|
In-lab testing will occur over the course of up to 2 hours at a time.
|
Extended Figure-of-8 Test
Time Frame: 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.
|
In-lab testing wil occur over the course of up to 2 hours at a time.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joan E Sanders, PhD, University of Washington
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2020
Primary Completion (Anticipated)
September 30, 2024
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
November 2, 2020
First Submitted That Met QC Criteria
November 9, 2020
First Posted (Actual)
November 10, 2020
Study Record Updates
Last Update Posted (Actual)
April 18, 2023
Last Update Submitted That Met QC Criteria
April 14, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00009120
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lower Limb; Fusion, Congenital
-
Otto Bock Healthcare Products GmbHHanger Clinic: Prosthetics & OrthoticsActive, not recruitingLower Limb Amputation Above Knee (Injury) | Lower Limb Amputation Knee | Congenital Amputation of Lower LimbUnited States
-
Liberating Technologies, Inc.Vivonics, Inc.CompletedAmputation | Prosthesis | Prosthesis User | Amputation Stumps | Amputees | Lower Limb Deformities, CongenitalUnited States
-
Liberating Technologies, Inc.Vivonics, Inc.CompletedLower Limb Amputation Below Knee (Injury) | Amputation | Prosthesis User | Amputation; Traumatic, Leg, Lower | Limb; Absence, Congenital, Lower | Amputation StumpUnited States
-
Liberating Technologies, Inc.Hanger Clinic: Prosthetics & OrthoticsRecruitingLower Limb Amputation Above Knee (Injury) | Amputation | Prosthesis User | Amputation; Traumatic, Leg, Lower | Limb; Absence, Congenital, Lower | Amputation; Traumatic, Leg: Thigh, Between Hip and KneeUnited States
-
Liberating Technologies, Inc.Hanger Clinic: Prosthetics & OrthoticsRecruitingLower Limb Amputation Above Knee (Injury) | Amputation | Prosthesis User | Amputation; Traumatic, Leg, Lower | Limb; Absence, Congenital, Lower | Amputation; Traumatic, Leg: Thigh, Between Hip and KneeUnited States
-
Sint MaartenskliniekCompletedLower Limb Amputation Above Knee (Injury) | Lower Limb Amputation KneeNetherlands
-
Tezel Yıldırım ŞahanCompletedValidity and Reliability of The 3-Meter Backward Walk Test in Individuals With Lower Limb AmputationLower Limb Amputation Below Knee (Injury) | Lower Limb Amputation KneeTurkey
-
Carmell Therapeutics CorporationWithdrawn
-
Józef Piłsudski University of Physical EducationCompletedAmputation | Dysmelia | Leg; Deformity, CongenitalPoland
-
GCS Ramsay Santé pour l'Enseignement et la RechercheCompleted
Clinical Trials on Variable Stiffness AFO
-
VA Palo Alto Health Care SystemCompleted
-
Shirley Ryan AbilityLabEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsNot yet recruiting
-
Northern Arizona UniversityRecruiting
-
University of DelawareRecruiting
-
Massachusetts Institute of TechnologyEnrolling by invitationTranstibial Amputation - UnilateralUnited States
-
National Cheng-Kung University HospitalCompletedGait AnalysisTaiwan
-
Texas Woman's UniversityBaylor Research InstituteCompletedStroke | Hemiplegia | Hemiparesis | Foot Drop | CVAUnited States
-
University of Texas Southwestern Medical CenterTerminated
-
Orthocare Innovations, LLCUniversity of Utah; Becker OrthopedicRecruiting