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Smart AFO for Stroke

Phase 2

Recruiting

Research Sponsored by Orthocare Innovations, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Foot drop during swing phase (often identified by a toe catch), on at least one side

Hemiplegia or hemiparesis as a result of stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed on day 1 (data collection day) with smart afo

Awards & highlights

Study Summary

This trial is testing a device designed to help people with stroke adjust their AFOs to optimize walking. It could help improve walking for post-stroke users.

Who is the study for?

This trial is for adults over 18 who've had a stroke, weigh less than 200 lbs, and currently use an Ankle-Foot Orthosis (AFO) due to foot drop. They should be able to walk safely for at least 100 feet and communicate in English. Excluded are those with other injuries or conditions that affect participation, pregnant individuals, non-English readers, or those needing bilateral upper limb support for walking.Check my eligibility

What is being tested?

The Smart AFO system is being tested on post-stroke patients who use AFOs. It's designed to help clinicians improve the user's gait by adjusting the orthosis stiffness and range of motion through a mobile app. The study will assess how well it works and if it can enhance walking function.See study design

What are the potential side effects?

Since this trial involves a physical assistive device rather than medication, traditional side effects are not expected. However, users may experience discomfort or skin issues where the AFO contacts the body if adjustments aren't optimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience foot drop when walking, noticeable by my toe catching.

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I have weakness or paralysis on one side of my body due to a stroke.

Select...

I currently use an AFO with a Triple Action Joint.

Select...

My ankles move normally without assistance.

Select...

I can walk 100 feet on flat ground without stopping.

Select...

I am 18 years old or older.

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I weigh less than 200 lbs.

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I can walk by myself safely on a treadmill.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed on day 1 (data collection day) with smart afo

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed on day 1 (data collection day) with smart afo

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed on day 1 (data collection day) with smart afo for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ankle

Ankle power

+3 more

Secondary outcome measures

Stride length

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Smart AFOExperimental Treatment1 Intervention

Group II: Participant's prescribed ankle-foot orthosisActive Control1 Intervention

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Orthocare Innovations, LLCLead Sponsor

8 Previous Clinical Trials

224 Total Patients Enrolled

3 Trials studying Stroke

110 Patients Enrolled for Stroke

Becker OrthopedicUNKNOWN

University of UtahOTHER

1,099 Previous Clinical Trials

1,778,639 Total Patients Enrolled

19 Trials studying Stroke

3,407 Patients Enrolled for Stroke

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participant count for this research project?

"Affirmative. Clinicaltrials.gov confirms that this medical experiment, originally posted on August 15th 2022, is actively searching for participants. Specifically, 50 patients are needed from 2 separate sites."

Answered by AI

Has the Smart AFO been granted regulatory acceptance by the FDA?

"Although there is still no definitive proof of efficacy, Smart AFO's prior use in clinical settings has yielded credible safety data. As such, it received a score of 2 on our team at Power's scale."

Answered by AI

Are there presently any openings for participation in this medical experiment?

"Affirmative. According to the data hosted on clinicaltrials.gov, this research study is actively recruiting patients and was initially posted on August 15th 2022. The trial requires 50 participants from two separate sites before it can be completed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Smart Ankle-Foot Orthosis to Improve Stroke Outcomes: Smart AFO". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05619484.