Clinical Validation of a Hybrid BCI-controlled FES for Upper Limb Rehabilitation After Stroke

NACompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

March 1, 2023

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Stroke SequelaeMotor Disorders
Interventions
DEVICE

RECOM - hBCI training

The RECOM device is a h-BCI system that controls FES of upper limb muscles: the patient is asked to attempt simple upper limb movements (eg extension of fingers); the device recognizes (in correct trials) close-to-normal EEG-EMG activation and initiates FES of extensor muscles in the forearm. RECOM training consists in a set of trial repetition for a total duration per session of approximately 20-30 minutes (excluding set up time and calibration). FES parameters will be set specifically for each patients according to standard guidelines to achieve full movement and so as to avoid any kind of discomfort for the patients. The intervention regimen will be 2-3 times per week for 4 consecutive weeks.

OTHER

CTRL - upper limb training with FES

An expert physiotherapist will define a set of active exercises focused on upper limb function; the exercises will be combined with FES of forearm muscles. FES parameters will be set specifically for each patients according to standard guidelines to achieve the full required movement and so as to avoid any kind of discomfort for the patients. Session duration will be approximately 20-30 minutes (excluding FES calibration time). The intervention regimen will be 2-3 times per week for 4 consecutive weeks.

Trial Locations (1)

00179

Neurorehabilitation Units- Fondazione Santa Lucia, IRCCS, Rome

All Listed Sponsors
collaborator

University of Roma La Sapienza

OTHER

lead

Donatella Mattia

OTHER