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

NCT05619484 | Unknown Phase 2 FDA Device

• 1 other identifier: 0019-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Stroke

Keywords

ankle-foot orthosis; orthotist

Outcome Measures

Primary Outcomes (12)

• Timed Up and Go (TUG) test

  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

  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

  Average ankle joint angle at foot flat after initial contact (degrees)

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

• Ankle plantarflexion

  Average ankle joint angle at foot flat after initial contact (degrees)

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

• Ankle power

  Average peak ankle joint power during stance phase (Newton-meters/second)

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

• Ankle power

  Average peak ankle joint power during stance phase (Newton-meters/second)

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

• Knee angle

  Average knee joint angle at midstance (degrees)

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

• Knee angle

  Average knee joint angle at midstance (degrees)

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

• Knee power

  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

  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

  Average ankle joint angle during midswing (degrees)

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

• Ankle dorsiflexion

  Average ankle joint angle during midswing (degrees)

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

Secondary Outcomes (2)

• Stride length

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

• Stride length

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

Study Arms (2)

Participant's prescribed ankle-foot orthosis

NO INTERVENTION

Smart AFO

EXPERIMENTAL

Device: Smart AFO

Interventions

Smart AFO DEVICE

Diagnostic ankle-foot orthosis with AFO stiffness and range of motion settings adjusted using a mobile application

Smart AFO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orthocare Innovations, LLC: lead
• Becker Orthopedic: collaborator
• University of Utah: collaborator

Study Sites (3)

Becker Orthopedic

Troy, Michigan, 48083, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84108, United States

ACTIVE NOT RECRUITING

Orthocare Innovations, LLC

Edmonds, Washington, 98020, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Adam Arabian

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: November 17, 2022
• Study Start: August 15, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)