Recruiting
Phase 2

Smart AFO

Sponsor:

Orthocare Innovations, LLC

Code:

NCT05619484

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Smart AFO

Study Details

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

Study ID

NCT05619484

Start date

Aug 15, 2022

Status verified date

Oct, 2023

Completion date

Aug 31, 2024

Anticipated

Primary completion date

Aug 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Participant's prescribed ankle-foot orthosis

experimental: Smart AFO

Interventions

Smart AFO

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

Primary outcome measure

  • Timed Up and Go (TUG) test [ Time Frame: 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 ]
  • Ankle plantarflexion [ Time Frame: Assessed on day 1 (data collection day) with prescribed AFO ]
  • Ankle plantarflexion [ Time Frame: Assessed on day 1 (data collection day) with Smart AFO ]
  • Ankle power [ Time Frame: Assessed on day 1 (data collection day) with prescribed AFO ]
  • Ankle power [ Time Frame: Assessed on day 1 (data collection day) with Smart AFO ]
  • Knee angle [ Time Frame: Assessed on day 1 (data collection day) with prescribed AFO ]
  • Knee angle [ Time Frame: Assessed on day 1 (data collection day) with Smart AFO ]
  • Knee power [ Time Frame: Assessed on day 1 (data collection day) with prescribed AFO ]
  • Knee power [ Time Frame: Assessed on day 1 (data collection day) with Smart AFO ]
  • Ankle dorsiflexion [ Time Frame: Assessed on day 1 (data collection day) with prescribed AFO ]
  • Ankle dorsiflexion [ Time Frame: Assessed on day 1 (data collection day) with Smart AFO ]

Central Contacts and Locations

Central contacts

Adam Arabian

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

Locations

Becker Orthopedic

Recruiting

Troy, Michigan, United States, 48083

Contacts

Adam Arabian, PhD

arabian@orthocareinnovations.com

Orthocare Innovations, LLC

Recruiting

Edmonds, Washington, United States, 98020

Contacts

Adam Arabian, PhD

425-771-0797arabian@orthocareinnovations.com

More Information

Sponsor

Orthocare Innovations, LLC

Last update posted

Oct 10, 2023

Last verified

Oct, 2023

Keywords

  • ankle-foot orthosis
  • orthotist

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Orthocare Innovations, LLC on 2023-10-10.