Clinical trial NCT04623853: Investigating Auto Adjusting Dynamic AFO
Official title: Investigating Auto Adjusting Dynamic AFO
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Limb; Fusion, Congenital
Lower Limb Fracture
Ankle Foot Injury
Keywords: Ankle foot orthotic
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2020-11-10
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Time Running Per Day
timeFrame: Calculated across all days of data collection (up to 4 weeks).
measure: Longest Running Bout Duration
timeFrame: Across all days of data collection (up to 4 weeks), the longest bout of continuous activity will be identified (minutes).
measure: PROMIS-Fatigue
timeFrame: 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.
measure: Pain Score
timeFrame: 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.
measure: Orthotic Evaluation Questionnaire (OEQ)
timeFrame: Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete an OEQ.
measure: Running Speed on Treadmill
timeFrame: In-lab testing will occur over the course of up to 2 hours at a time.
measure: Extended Figure-of-8 Test
timeFrame: In-lab testing wil occur over the course of up to 2 hours at a time.
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington, Dept. of Bioengineering
state: Washington
Study officials:
affiliation: University of Washington
name: Joan E Sanders, PhD
role: PRINCIPAL_INVESTIGATOR
References: