CompletedNot Applicable

Wearable Grasping Neuroprosthesis Used at Home in Subjects With Post-stroke Hemiparesis

France6 participantsStarted 2023-01-17

Plain-language summary

The study is focused on the evaluation of the feasibility, usability, acceptability, tolerance, functional impact and organizational impact of the use of a wearable prehension neuroprosthesis (innovative medical device) at home, with triggering methods specifically adapted to a population of hemiparetic post-stroke subjects. The main objective is to describe the overall therapeutic compliance represented by the number of uses of the neuroprosthesis in real-life situations.

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: * Paresis of an upper limb from a single ischemic or hemorrhagic, hemispheric or brainstem stroke, as evidenced by brain imaging (CT or MRI); * Stroke more than one month old; * Impossibility to actively expand the fingers 2 to 5 (opening of the hand) to intentionally grab an empty glass (identical to the material used for the Action Research scale Arm Test), with a palmar grip (cylindrical grip), while the subject can hold the glass passively placed in the hand and/or the thumb to voluntarily grab the handle of a tablespoon (flat, like a wrench) with a key-grip (identical to that of the Wolf Motor Function Test), while the subject can hold the spoon previously placed passively between thumb and index; * Ability to sit on a chair at least during 1h30. Participants must have participated in and completed the PREHENS-STROKE protocol, having successfully achieved a functional gain through the use of the neuroprosthesis. * Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any investigation required by the research); * Affiliate or beneficiary of the French health insurance system; * The person is of age (at least 18 years old); * Women and men are included; * The patient is available for a follow-up of 5 days as part of his hospitalization performed as part of routine care. Exclusion Criteria: * The person is parturient, or is breastfeeding; * The person is pregnant, the diagn…

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

Compliance with the use of the neuroprosthesis

Timeframe: through study completion, mean of daily collection during 2 month

Trial details

NCT IDNCT05625113

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-23

View on ClinicalTrials.gov More Stroke, Rehabilitation trials