Recruiting

Dynamic Brace

Sponsor:

University of Washington

Code:

NCT04623853

Conditions

Lower Limb; Fusion, Congenital

Lower Limb Fracture

Ankle Foot Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Variable Stiffness AFO

Study Details

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

Study ID

NCT04623853

Start date

Nov 30, 2020

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

22 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Aim 2

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

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.

Interventions

Variable Stiffness AFO

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

Primary outcome measure

  • Time Running Per Day [ Time Frame: 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). ]
  • 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. ]
  • 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. ]
  • 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. ]
  • Running Speed on Treadmill [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Joan Sanders, PhD

206-221-5872jsanders@uw.edu

Katheryn Allyn, CPO, LPO

206-390-0228

Locations

University of Washington, Dept. of Bioengineering

Recruiting

Seattle, Washington, United States, 98105

Contacts

Joan Sanders, PhD

206-221-5872jsanders@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Nov 4, 2026

Last verified

Apr, 2026

Keywords

  • Ankle foot orthotic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by University of Washington on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.