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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.
Nearly 80% of stroke survivors are affected by a grip deficit. Studies had shown the potential interest of functional supplementation by functional electrical stimulation of the fingers' extensor muscles to restore gripping capacities. The limit of some studies is that they assess gripping abilities in a hospital environment, which is a non-ecological situation very different from the daily life situations. The interest of this type of device will only be established if it restores gripping capacities in the daily life of the subjects in order to allow them to improve their level of autonomy and their quality of life. The objective of the study will be to test the feasibility and usability of a wearable version of a gripping neuroprosthesis in daily life situations. The subjects will use the neuroprosthesis for 2 months at home with evaluations at the beginning and at the end of the protocol associated with a weekly follow-up in order to evaluate the modalities of use and the functional benefits linked to its use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neuroprosthesis | Experimental | This is a prospective, monocentric, real-life, feasibility case series, succeeding to the PREHENS-STROKE study, aimed at assessing the feasibility, acceptability, tolerance, efficacy and organizational impact of the use of a gripping neuroprosthesis at home (innovative medical device) in a population of vascular hemiparetic patients. The study consists of an initial phase of inclusion and evaluation (T1 and T2), an intermediate phase (T3 to T9) of learning and use of the gripping neuroprosthesis at home by the patient and a final phase (T10 and T11) of evaluation of the impact of the use of the neuroprosthesis. Each patient is their own control (self-matching). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neuroprosthesis | Device | Use at least one time every day the gripping neuroprosthesis in daily life activities. |
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| Measure | Description | Time Frame |
|---|---|---|
| Compliance with the use of the neuroprosthesis | Overall therapeutic compliance described by the proportion of days when at least one task was performed compared to the number of days when the neuroprosthesis was available and functional (concept of delivered dose), independently of the functional task performed. This indicator is recorded automatically by the neuroprosthesis software (objective outcome). In the event of non-compliance, the data collected in the logbook, in the observation book and by the neuroprosthesis will make it possible to explain the reasons. This criterion will be evaluated at the end of the protocol. | through study completion, mean of daily collection during 2 month |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of daily use of the neuroprosthesis | Feasibility of the use of neuroprosthesis in daily life by analysis of therapeutic observance. It is described during the last visit of the protocol with the data collected during the protocol in the observation notebook by the therapist, the logbook by the patient or automatically recorded by the neuroprosthesis software. The dose delivered and the dose received will be described individually and a median value and its span (minimum - maximum) will be given to describe the population. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David GASQ, MD PhD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Toulouse | Toulouse | 31000 | France |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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One arm with participants who are not blinded. All participants benefit from the intervention (neuroprosthesis). Some outcomes (functional unimanual and bimanual task, ARAT) are blinded regarding whether or not the neuroprosthesis is activated (assessment from videos).
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| through study completion, mean of daily collection during 2 month |
| Efficacy related to the use of neuroprosthesis | Comparison of the quality of one-handed grips between the beginning and the end of the protocol with neuroprosthesis activated/inactivated (analysis of blinded videos) with standardized one-handed gripping tasks and the Action Arm Research Test (ARAT) scale. | through study completion, mean of daily collection during 2 month |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |