Lower Limb; Fusion, CongenitalNCT04623853
Investigating Auto Adjusting Dynamic AFO
A study testing Variable Stiffness AFO in people with Lower Limb; Fusion, Congenital and Lower Limb Fracture, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lower Limb; Fusion, Congenital, Lower Limb Fracture, Ankle Foot Injury
- What is being tested?
- Variable Stiffness AFO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2020to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -able to run continuously for 1 minute
- 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
Who cannot join
- limited sensation in the lower limbs
- use an assistive device
- Unable to ambulate (walk/run) continuously with AFO for at least 1 minute
- Unable to sit, stand, or negotiate a step onto lab treadmill
Trial locations and contacts
1 site in 1 country.
Katheryn Allyn, CPO, LPO contact
United States1 site, 1 recruiting
- Recruiting
University of Washington, Dept. of Bioengineering
Seattle, Washington, 98105
Daniel Ballesteros, 206-221-5873
About this study
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.
- Being tested
- Variable Stiffness AFO
- Keywords
- Ankle foot orthotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variable Stiffness AFODevice
The Dynamic AFO is able to adjust in stiffness depending on activity.
| Study group | Role | What they receive |
|---|---|---|
| Aim 2 | Experimental | Participants will carry out a protocol comprised of treadmill walking in a laboratory setting while wearing the Dynamic AFO device. Receives: Device: Variable Stiffness AFO |
| Aim 3 | Experimental | 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. Receives: Device: Variable Stiffness AFO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Running Per Day
Collected while participant uses device in free-living environment.
Measured: Calculated across all days of data collection (up to 4 weeks).
Longest Running Bout Duration
Collected while participant uses device in free-living environment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: In-lab testing wil occur over the course of up to 2 hours at a time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start30 Nov 2020
- Primary completion30 Sep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb; Fusion, CongenitalStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Joan Sanders, University of Washington
- Investigators
- Joan E Sanders, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623853
- Sponsor's protocol ID
- STUDY00009120
- Status last verified
- Apr 2023
- First submitted
- 2 Nov 2020
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Auto Adjusting Dynamic AFO
- ClinicalTrials.gov ID
- NCT04623853
- Acronym / sponsor ID
- STUDY00009120
- Keywords
- Ankle foot orthotic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim 2 | Experimental | Device: Variable Stiffness AFOParticipants will carry out a protocol comprised of treadmill walking in a laboratory setting while wearing the Dynamic AFO device. |
| Aim 3 | Experimental | Device: Variable Stiffness AFOParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- -able to run continuously for 1 minute
- 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
Key exclusion criteria (4 listed)
- limited sensation in the lower limbs
- use an assistive device
- Unable to ambulate (walk/run) continuously with AFO for at least 1 minute
- Unable to sit, stand, or negotiate a step onto lab treadmill
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Variable Stiffness AFOThe Dynamic AFO is able to adjust in stiffness depending on activity. | Device | Aim 2, Aim 3 |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katheryn Allyn, CPO, LPO contact
Joan E Sanders, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Variable Stiffness AFO in people with Lower Limb; Fusion, Congenital and Lower Limb Fracture, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Ballesteros, BS (206-221-5873, danielb25@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Running Per Day (time frame: Calculated across all days of data collection (up to 4 weeks).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.