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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
6
Use at least one time every day the gripping neuroprosthesis in daily life activities.
University Hospital Toulouse
Toulouse, France
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.
Time frame: through study completion, mean of daily collection during 2 month
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.
Time frame: 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.
Time frame: through study completion, mean of daily collection during 2 month
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