Investigating Auto Adjusting Dynamic AFO

NCT04623853 | Unknown FDA Device

• 1 other identifier: STUDY00009120
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Ankle foot orthotic

Outcome Measures

Primary Outcomes (7)

• Time Running Per Day

  Collected while participant uses device in free-living environment.

  Calculated across all days of data collection (up to 4 weeks).

• 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).

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Aim 2

EXPERIMENTAL

Participants will carry out a protocol comprised of treadmill walking in a laboratory setting while wearing the Dynamic AFO device.

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.

Device: Variable Stiffness AFO

Interventions

Variable Stiffness AFO DEVICE

The Dynamic AFO is able to adjust in stiffness depending on activity.

Aim 2; Aim 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Washington, Dept. of Bioengineering

Seattle, Washington, 98105, United States

RECRUITING

Study Officials

• Joan E Sanders, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Ballesteros, BS

CONTACT

206-221-5873; danielb25@uw.edu

Katheryn Allyn, CPO, LPO

CONTACT

206-390-0228

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: Engineering

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 10, 2020
• Study Start: November 30, 2020
• Primary Completion: September 30, 2024
• Study Completion: December 1, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

US (1)