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NCT05619484RECRUITINGIRB Ready

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

Sponsored by Orthocare Innovations, LLC

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 50 participants interested
2% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

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
Not able to read and understand English
Use of assistive device that requires bilateral upper extremities

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

50 participants

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Gender

ALL

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Sponsor

Orthocare Innovations, LLC

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Troy

Michigan

Location available
View Troy location page
ACTIVE_NOT_RECRUITING

Salt Lake City

Utah

Location available
View Salt Lake City location page
RECRUITING

Edmonds

Washington

Location available
View Edmonds location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Stroke Treatment in Troy?

Join others in Michigan exploring innovative treatment options through clinical research

Stroke Treatment Options in Troy, Michigan

If you're searching for Stroke treatment in Troy, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Troy, Salt Lake City, Edmonds and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Stroke. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Michigan
Now Enrolling
Up to 50 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Stroke?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Stroke

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Stroke Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05619484. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.