NCT05625113

Wearable Grasping Neuroprosthesis Used At Home in Subjects with Post-stroke Hemiparesis

Pilot Study Evaluating the Feasibility, Usability and Functional Impact of a Wearable Grasping Neuroprosthesis Used At Home in Subjects with Post-stroke Hemiparesis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Stroke, Rehabilitation

Interventions

Type	Name	Description
DEVICE	neuroprosthesis	Use at least one time every day the gripping neuroprosthesis in daily life activities.

Timeline

• Start date: 2023-01-17
• Primary completion: 2023-07-23
• Completion: 2023-07-23
• First posted: 2022-11-22
• Last updated: 2024-10-23

Locations

1 site across 1 country: France