Investigating Auto Adjusting Dynamic AFO

University of Washington

Status: Enrolling

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

Treatments: Device: Variable Stiffness AFO

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04623853

STUDY00009120

Details and patient eligibility

About

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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

22 participants in 2 patient groups

Aim 2

Experimental group

Description:

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

Treatment:

Device: Variable Stiffness AFO

Aim 3

Experimental group

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.

Treatment:

Device: Variable Stiffness AFO