UnknownNot Applicable

Evaluation of the Effectiveness and Safety of Keeogo™ Dermoskeleton in Subjects With Mobility Impairments Due to Stroke

United States, Canada60 participantsStarted 2019-07-22

Plain-language summary

A multi-site, interventional, non-comparative, single-arm trial to evaluate the safety of the Keeogo™ Dermoskeleton in subjects with hemiparesis due to ischemic or hemorrhagic stroke.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: To be eligible to participate in this study, an individual must meet all of the following criteria: * Provide signed and dated informed consent form; * Willing to comply with all study procedures and be available for the duration of the study \[2-3 days per week, 3-5 consecutive weeks\]; * Adults 18 years of age and older; * Confirmed Cerebrovascular Accident (CVA) with hemiparesis; * Stable stroke (≥ 6 months post-incident) * Sufficient cognition to follow simple instructions and understand the content and purpose of the study (MMSE \> 20); * Capable of standing and walking independently for an extended period of time (MMT * 3 hip flexors and extensors, and ≥ 2 knee flexors and extensors with BBS ≥ 45); * Presence of any gait deficit, as defined by one or more of the following clinical observations: * Hip hike * Hip circumduction * Knee spasticity (MAS 2 to 3) as per Modified Ashworth Scale (MAS) * Mid-foot striking (aka 'flat foot landing') * Poor foot clearance (toe/foot drop or foot drag) * Narrow steps (\< 1 shoe-width or \< 8 cm) * Manual Muscle Test (MMT) of 4/5 for the unaffected upper extremity; * Able to sit on a bench for more than 5 minutes; * Is physically and mentally compatible with device to demonstrate ability to safely activate the Keeogo™ user interface; * Able to understand and follow instructions with assistance if needed. Exclusion Criteria: An individual who meets any of the following criteria will be excluded fro…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of device-related adverse events [Safety]

Timeframe: Duration of study participation for each subject, estimated 3-5 weeks

Trial details

NCT IDNCT03986320

SponsorB-Temia, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-03

View on ClinicalTrials.gov More Stroke, Ischemic trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.