NCT04889586

Hand MOtor Rehabilitation Using a EMG-biofeedback: a Cross-sectional Study

Hand Motor Recovery Using a EMG-biofeedback in Stroke Rehabilitation: a Cross-sectional Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: IRCCS San Camillo, Venezia, Italy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Stroke Hemorrhagic
• Stroke, Ischemic
• Hemiparesis
• Hemiplegia

Interventions

Type	Name	Description
DEVICE	EMG-biofeedback armband (REMO)	After clinical evaluation, the subjects execute an instrumental test. By wearing EMG-biofeedback device (REMO), the subjects have to perform 10 different hand gestures: thumb abduction, pinch, finger flexion, finger extension, wrist flexion, wrist extension, forearm pronation, forearm supination, radial wrist deviation and ulnar wrist deviation. The muscle activations (EMG signals) during the execution of each movements, are recorded for 3 seconds.

Timeline

• Start date: 2017-07-25
• Primary completion: 2019-02-11
• Completion: 2019-02-27
• First posted: 2021-05-17
• Last updated: 2021-05-17

Locations

1 site across 1 country: Italy