StrokePhase 2NCT05619484
Smart Ankle-Foot Orthosis to Improve Stroke Outcomes: Smart AFO
A Phase 2 study testing Smart AFO in people with Stroke, run by Orthocare Innovations, LLC at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Smart AFO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Aug 2022to 31 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 2 recruiting
- Recruiting
Orthocare Innovations, LLC
Edmonds, Washington, 98020
Adam Arabian, PhD, 425-771-0797, arabian@orthocareinnovations.com
- Active, not recruiting
University of Utah
Salt Lake City, Utah, 84108
- Recruiting
Becker Orthopedic
Troy, Michigan, 48083
Adam Arabian, PhD, arabian@orthocareinnovations.com
About this study
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
- Being tested
- Smart AFO
- Keywords
- ankle-foot orthosis, orthotist
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart AFODevice
Diagnostic ankle-foot orthosis with AFO stiffness and range of motion settings adjusted using a mobile application
| Study group | Role | What they receive |
|---|---|---|
| Participant's prescribed ankle-foot orthosis | No intervention | Not described |
| Smart AFO | Experimental | Not described Receives: Device: Smart AFO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Assessed on day 1 (data collection day) with Smart AFO
Ankle plantarflexion
Average ankle joint angle at foot flat after initial contact (degrees)
Measured: Assessed on day 1 (data collection day) with prescribed AFO
Ankle plantarflexion
Average ankle joint angle at foot flat after initial contact (degrees)
Measured: Assessed on day 1 (data collection day) with Smart AFO
Ankle power
Average peak ankle joint power during stance phase (Newton-meters/second)
Measured: Assessed on day 1 (data collection day) with prescribed AFO
Ankle power
Average peak ankle joint power during stance phase (Newton-meters/second)
Measured: Assessed on day 1 (data collection day) with Smart AFO
Knee angle
Average knee joint angle at midstance (degrees)
Measured: Assessed on day 1 (data collection day) with prescribed AFO
Knee angle
Average knee joint angle at midstance (degrees)
Measured: 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)
Measured: 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)
Measured: Assessed on day 1 (data collection day) with Smart AFO
Ankle dorsiflexion
Average ankle joint angle during midswing (degrees)
Measured: Assessed on day 1 (data collection day) with prescribed AFO
Ankle dorsiflexion
Average ankle joint angle during midswing (degrees)
Measured: Assessed on day 1 (data collection day) with Smart AFO
Secondary outcomes (2)
Stride length
Average stride length of steps (meters)
Measured: Assessed on day 1 (data collection day) with prescribed AFO
Stride length
Average stride length of steps (meters)
Measured: Assessed on day 1 (data collection day) with Smart AFO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start15 Aug 2022
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orthocare Innovations, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Becker Orthopedic, University of Utah
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619484
- Sponsor's protocol ID
- 0019-01
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Ankle-Foot Orthosis to Improve Stroke Outcomes: Smart AFO
- ClinicalTrials.gov ID
- NCT05619484
- Acronym / sponsor ID
- 0019-01
- Conditions
- Stroke
- Keywords
- ankle-foot orthosis, orthotist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Orthocare Innovations, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Becker Orthopedic, University of Utah
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participant's prescribed ankle-foot orthosis | No intervention | – |
| Smart AFO | Experimental | Device: Smart AFO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart AFODiagnostic ankle-foot orthosis with AFO stiffness and range of motion settings adjusted using a mobile application | Device | Smart AFO |
Primary outcome
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.
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.
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)
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)
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)
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)
Knee angle
Time frame: Assessed on day 1 (data collection day) with prescribed AFO
Average knee joint angle at midstance (degrees)
Knee angle
Time frame: Assessed on day 1 (data collection day) with Smart AFO
Average knee joint angle at midstance (degrees)
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)
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)
Ankle dorsiflexion
Time frame: Assessed on day 1 (data collection day) with prescribed AFO
Average ankle joint angle during midswing (degrees)
Ankle dorsiflexion
Time frame: Assessed on day 1 (data collection day) with Smart AFO
Average ankle joint angle during midswing (degrees)
2 secondary outcomes
Stride length
Time frame: Assessed on day 1 (data collection day) with prescribed AFO
Stride length
Time frame: Assessed on day 1 (data collection day) with Smart AFO
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Smart AFO in people with Stroke, run by Orthocare Innovations, LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam Arabian (1-425-771-0797, arabian@orthocareinnovations.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) test (time frame: Assessed on day 1 (data collection day) with prescribed AFO). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.