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

October 6, 2023 updated by: Orthocare Innovations, LLC
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Michigan
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Active, not recruiting
        • University of Utah
    • Washington
      • Edmonds, Washington, United States, 98020

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Participant's prescribed ankle-foot orthosis
Experimental: Smart AFO
Device: Smart AFO
Diagnostic ankle-foot orthosis with AFO stiffness and range of motion settings adjusted using a mobile application

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Timed Up and Go (TUG) test
Time Frame: Assessed on day 1 (data collection day) with prescribed AFO
The Timed Up and Go (TUG) test is a validated timed functional test that involves standing up from a chair, walking forward for 3 meters, turning around, walking back to the chair for 3 meter, and sitting down. Measured in seconds.
Assessed on day 1 (data collection day) with prescribed AFO
Timed Up and Go (TUG) test
Time Frame: Assessed on day 1 (data collection day) with Smart AFO
The Timed Up and Go (TUG) test is a validated timed functional test that involves standing up from a chair, walking forward for 3 meters, turning around, walking back to the chair for 3 meter, and sitting down. Measured in seconds.
Assessed on day 1 (data collection day) with Smart AFO
Ankle plantarflexion
Time Frame: Assessed on day 1 (data collection day) with prescribed AFO
Average ankle joint angle at foot flat after initial contact (degrees)
Assessed on day 1 (data collection day) with prescribed AFO
Ankle plantarflexion
Time Frame: Assessed on day 1 (data collection day) with Smart AFO
Average ankle joint angle at foot flat after initial contact (degrees)
Assessed on day 1 (data collection day) with Smart AFO
Ankle power
Time Frame: Assessed on day 1 (data collection day) with prescribed AFO
Average peak ankle joint power during stance phase (Newton-meters/second)
Assessed on day 1 (data collection day) with prescribed AFO
Ankle power
Time Frame: Assessed on day 1 (data collection day) with Smart AFO
Average peak ankle joint power during stance phase (Newton-meters/second)
Assessed on day 1 (data collection day) with Smart AFO
Knee angle
Time Frame: Assessed on day 1 (data collection day) with prescribed AFO
Average knee joint angle at midstance (degrees)
Assessed on day 1 (data collection day) with prescribed AFO
Knee angle
Time Frame: Assessed on day 1 (data collection day) with Smart AFO
Average knee joint angle at midstance (degrees)
Assessed on day 1 (data collection day) with Smart AFO
Knee power
Time Frame: Assessed on day 1 (data collection day) with prescribed AFO
Average knee joint power at foot flat after initial contact (Newton-meters/second)
Assessed on day 1 (data collection day) with prescribed AFO
Knee power
Time Frame: Assessed on day 1 (data collection day) with Smart AFO
Average knee joint power at foot flat after initial contact (Newton-meters/second)
Assessed on day 1 (data collection day) with Smart AFO
Ankle dorsiflexion
Time Frame: Assessed on day 1 (data collection day) with prescribed AFO
Average ankle joint angle during midswing (degrees)
Assessed on day 1 (data collection day) with prescribed AFO
Ankle dorsiflexion
Time Frame: Assessed on day 1 (data collection day) with Smart AFO
Average ankle joint angle during midswing (degrees)
Assessed on day 1 (data collection day) with Smart AFO

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stride length
Time Frame: Assessed on day 1 (data collection day) with prescribed AFO
Average stride length of steps (meters)
Assessed on day 1 (data collection day) with prescribed AFO
Stride length
Time Frame: Assessed on day 1 (data collection day) with Smart AFO
Average stride length of steps (meters)
Assessed on day 1 (data collection day) with Smart AFO

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Orthocare Innovations, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Utah
Becker Orthopedic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0019-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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