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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Orthocare Innovations, LLC

Collaborators

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)

August 15, 2022

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

October 10, 2022

First Submitted That Met QC Criteria

November 11, 2022

First Posted (Actual)

November 17, 2022

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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