UnknownPhase 2

Smart Ankle-Foot Orthosis to Improve Stroke Outcomes: Smart AFO

United States50 participantsStarted 2022-08-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Timed Up and Go (TUG) test

Timeframe: Assessed on day 1 (data collection day) with prescribed AFO

Timed Up and Go (TUG) test

Timeframe: Assessed on day 1 (data collection day) with Smart AFO

Ankle plantarflexion

Timeframe: Assessed on day 1 (data collection day) with prescribed AFO

Ankle plantarflexion

Timeframe: Assessed on day 1 (data collection day) with Smart AFO

Ankle power

Timeframe: Assessed on day 1 (data collection day) with prescribed AFO

Ankle power

Timeframe: Assessed on day 1 (data collection day) with Smart AFO

Knee angle

Timeframe: Assessed on day 1 (data collection day) with prescribed AFO

Trial details

NCT IDNCT05619484

SponsorOrthocare Innovations, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-31

Contact for this trial

Adam Arabian

1-425-771-0797 arabian@orthocareinnovations.com

View on ClinicalTrials.gov More Stroke trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Timed Up and Go (TUG) test

Timeframe: Assessed on day 1 (data collection day) with prescribed AFO

Timed Up and Go (TUG) test

Timeframe: Assessed on day 1 (data collection day) with Smart AFO

Ankle plantarflexion

Timeframe: Assessed on day 1 (data collection day) with prescribed AFO

Ankle plantarflexion

Timeframe: Assessed on day 1 (data collection day) with Smart AFO

Ankle power

Timeframe: Assessed on day 1 (data collection day) with prescribed AFO

Ankle power

Timeframe: Assessed on day 1 (data collection day) with Smart AFO

Knee angle

Timeframe: Assessed on day 1 (data collection day) with prescribed AFO