Back to resultsSmart Ankle-Foot Orthosis to Improve Stroke Outcomes: Smart AFO
Primary Purpose
Stroke
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Smart AFO
Sponsored by
About this trial
This is an interventional other trial for Stroke focused on measuring ankle-foot orthosis, orthotist
Eligibility Criteria
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
Sites / Locations
- Becker OrthopedicRecruiting
- University of Utah
- Orthocare Innovations, LLCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Participant's prescribed ankle-foot orthosis
Smart AFO
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Ankle plantarflexion
Average ankle joint angle at foot flat after initial contact (degrees)
Ankle plantarflexion
Average ankle joint angle at foot flat after initial contact (degrees)
Ankle power
Average peak ankle joint power during stance phase (Newton-meters/second)
Ankle power
Average peak ankle joint power during stance phase (Newton-meters/second)
Knee angle
Average knee joint angle at midstance (degrees)
Knee angle
Average knee joint angle at midstance (degrees)
Knee power
Average knee joint power at foot flat after initial contact (Newton-meters/second)
Knee power
Average knee joint power at foot flat after initial contact (Newton-meters/second)
Ankle dorsiflexion
Average ankle joint angle during midswing (degrees)
Ankle dorsiflexion
Average ankle joint angle during midswing (degrees)
Secondary Outcome Measures
Stride length
Average stride length of steps (meters)
Stride length
Average stride length of steps (meters)
Full Information
NCT ID
NCT05619484
First Posted
October 10, 2022
Last Updated
October 6, 2023
Sponsor
Orthocare Innovations, LLC
Collaborators
Becker Orthopedic, University of Utah
1. Study Identification
Unique Protocol Identification Number
NCT05619484
Brief Title
Smart Ankle-Foot Orthosis to Improve Stroke Outcomes: Smart AFO
Official Title
Smart Ankle-Foot Orthosis to Improve Stroke Outcomes: Smart AFO
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orthocare Innovations, LLC
Collaborators
Becker Orthopedic, University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
ankle-foot orthosis, orthotist
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participant's prescribed ankle-foot orthosis
Arm Type
No Intervention
Arm Title
Smart AFO
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Smart AFO
Intervention Description
Diagnostic ankle-foot orthosis with AFO stiffness and range of motion settings adjusted using a mobile application
Primary Outcome Measure Information:
Title
Timed Up and Go (TUG) test
Description
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.
Time Frame
Assessed on day 1 (data collection day) with prescribed AFO
Title
Timed Up and Go (TUG) test
Description
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.
Time Frame
Assessed on day 1 (data collection day) with Smart AFO
Title
Ankle plantarflexion
Description
Average ankle joint angle at foot flat after initial contact (degrees)
Time Frame
Assessed on day 1 (data collection day) with prescribed AFO
Title
Ankle plantarflexion
Description
Average ankle joint angle at foot flat after initial contact (degrees)
Time Frame
Assessed on day 1 (data collection day) with Smart AFO
Title
Ankle power
Description
Average peak ankle joint power during stance phase (Newton-meters/second)
Time Frame
Assessed on day 1 (data collection day) with prescribed AFO
Title
Ankle power
Description
Average peak ankle joint power during stance phase (Newton-meters/second)
Time Frame
Assessed on day 1 (data collection day) with Smart AFO
Title
Knee angle
Description
Average knee joint angle at midstance (degrees)
Time Frame
Assessed on day 1 (data collection day) with prescribed AFO
Title
Knee angle
Description
Average knee joint angle at midstance (degrees)
Time Frame
Assessed on day 1 (data collection day) with Smart AFO
Title
Knee power
Description
Average knee joint power at foot flat after initial contact (Newton-meters/second)
Time Frame
Assessed on day 1 (data collection day) with prescribed AFO
Title
Knee power
Description
Average knee joint power at foot flat after initial contact (Newton-meters/second)
Time Frame
Assessed on day 1 (data collection day) with Smart AFO
Title
Ankle dorsiflexion
Description
Average ankle joint angle during midswing (degrees)
Time Frame
Assessed on day 1 (data collection day) with prescribed AFO
Title
Ankle dorsiflexion
Description
Average ankle joint angle during midswing (degrees)
Time Frame
Assessed on day 1 (data collection day) with Smart AFO
Secondary Outcome Measure Information:
Title
Stride length
Description
Average stride length of steps (meters)
Time Frame
Assessed on day 1 (data collection day) with prescribed AFO
Title
Stride length
Description
Average stride length of steps (meters)
Time Frame
Assessed on day 1 (data collection day) with Smart AFO
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Arabian
Phone
1-425-771-0797
Email
arabian@orthocareinnovations.com
Facility Information:
Facility Name
Becker Orthopedic
City
Troy
State/Province
Michigan
ZIP/Postal Code
48083
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Arabian, PhD
Email
arabian@orthocareinnovations.com
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Orthocare Innovations, LLC
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Arabian, PhD
Phone
425-771-0797
Email
arabian@orthocareinnovations.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Smart Ankle-Foot Orthosis to Improve Stroke Outcomes: Smart AFO
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