Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04889586
Status:
COMPLETED
Last Update Posted:
2021-05-17
First Post:
2021-05-06
Brief Title:
Hand MOtor Rehabilitation Using a EMG-biofeedback a Cross-sectional Study
Sponsor:
IRCCS San Camillo Venezia Italy
Organization:
IRCCS San Camillo Venezia Italy
Study Overview
Official Title:
Hand Motor Recovery Using a EMG-biofeedback in Stroke Rehabilitation a Cross-sectional Study
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MORE
Brief Summary:
Recovery of upper limb and hand gestures is fundamental for autonomy restoration after stroke Innovative technologies are a valid support for the delivery of rehabilitation treatments Embedding surface electromyographic sEMG into wearable devices allows the customisation of rehabilitation exercises based on the clinical profile of each patient
Detailed Description:
The aims of this study are to determine safety and feasibility of a prototype EMG-control wearable device REMO and to individualise clinical features of stroke survivors able to control the EMG armband targeted to hand rehabilitation
The device REMO consists in an armband composed by 8 bipolar electrodes able to record and process the electromyography of forearm muscles The patterns of muscle activations are classified and used to perform EMG-biofeedback exercises in stroke rehabilitation training The device is developed by clinicians of IRCCS San Camillo Hospital and spin-off Morecognition Srl
A total of 100 stroke patients patients has been recruited They are clinically assessed and then tested on the ability to control the sEMG wearable device The test is composed of 10 hand and fingers gestures to be performed with the paretic hand Baseline and activation sEMG signals are recorded and compared for each movement Three conditions representing absent partial or full control of the device are defined and logistic multivarialbes regression models are used to identify clinical features describing the group each patient belongs to Clinical cut-off for each strata is identified by odds ratio
The device REMO consists in an armband composed by 8 bipolar electrodes able to record and process the electromyography of forearm muscles The patterns of muscle activations are classified and used to perform EMG-biofeedback exercises in stroke rehabilitation training The device is developed by clinicians of IRCCS San Camillo Hospital and spin-off Morecognition Srl
A total of 100 stroke patients patients has been recruited They are clinically assessed and then tested on the ability to control the sEMG wearable device The test is composed of 10 hand and fingers gestures to be performed with the paretic hand Baseline and activation sEMG signals are recorded and compared for each movement Three conditions representing absent partial or full control of the device are defined and logistic multivarialbes regression models are used to identify clinical features describing the group each patient belongs to Clinical cut-off for each strata is identified by odds ratio
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None