Clinical trial NCT05619484: Smart Ankle-Foot Orthosis to Improve Stroke Outcomes: Smart AFO
Official title: Smart Ankle-Foot Orthosis to Improve Stroke Outcomes: Smart AFO
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Stroke
Keywords: ankle-foot orthosis
orthotist
Lead sponsor: Orthocare Innovations, LLC
Sponsor class: INDUSTRY
Collaborators: name: Becker Orthopedic
name: University of Utah
First posted: 2022-11-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The Smart Ankle-Foot Orthosis (Smart AFO) system is an investigational system that combines a diagnostic ankle-foot orthosis with a mobile application to assist clinicians in optimizing an AFO user's gait by adjusting AFO stiffness and range of motion settings, and quantifying functional walking improvements in post-stroke individuals. The purpose of the clinical testing is to evaluate the Smart AFO system with its target users: post-stroke AFO users and orthotists. This may include, but is not limited to, identifying any aspects of the Smart AFO system that could be improved through clinical testing and evaluating the gait of post-stroke AFO users walking with an AFO adjusted using the Smart AFO system.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Mass less than 90 kg (200 lbs)
* At least six months post-stroke
* Hemiplegia or hemiparesis as a result of stroke
* Foot drop during swing phase (often identified by a toe catch), on at least one side
* Current user of an AFO
* Current user of an AFO with a Triple Action Joint is acceptable
* Has bilateral passive ankle range of motion within normal limits
* Able to walk safely on level ground for at least 100 feet without rest
* Able to communicate individual perceptions in the English language
* Able to provide written informed consent
* Participants that will use a treadmill during data collection must also be able to walk independently and safely on an instrumented treadmill

Exclusion Criteria:

* Confounding injury, musculoskeletal issues, or cognitive issues that limit effective participation
* Pregnancy
* Not able to read and understand English
* Use of assistive device that requires bilateral upper extremities

Primary outcomes:
measure: Timed Up and Go (TUG) test
timeFrame: Assessed on day 1 (data collection day) with prescribed AFO
measure: Timed Up and Go (TUG) test
timeFrame: Assessed on day 1 (data collection day) with Smart AFO
measure: Ankle plantarflexion
timeFrame: Assessed on day 1 (data collection day) with prescribed AFO
measure: Ankle plantarflexion
timeFrame: Assessed on day 1 (data collection day) with Smart AFO
measure: Ankle power
timeFrame: Assessed on day 1 (data collection day) with prescribed AFO
measure: Ankle power
timeFrame: Assessed on day 1 (data collection day) with Smart AFO
measure: Knee angle
timeFrame: Assessed on day 1 (data collection day) with prescribed AFO
measure: Knee angle
timeFrame: Assessed on day 1 (data collection day) with Smart AFO
measure: Knee power
timeFrame: Assessed on day 1 (data collection day) with prescribed AFO
measure: Knee power
timeFrame: Assessed on day 1 (data collection day) with Smart AFO
measure: Ankle dorsiflexion
timeFrame: Assessed on day 1 (data collection day) with prescribed AFO
measure: Ankle dorsiflexion
timeFrame: Assessed on day 1 (data collection day) with Smart AFO
Secondary outcomes:
measure: Stride length
timeFrame: Assessed on day 1 (data collection day) with prescribed AFO
measure: Stride length
timeFrame: Assessed on day 1 (data collection day) with Smart AFO
Other outcomes:
Locations:
city: Troy
country: United States
facility: Becker Orthopedic
state: Michigan
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Edmonds
country: United States
facility: Orthocare Innovations, LLC
state: Washington
Study officials:
References: