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

IRCCS San Camillo, Venezia, Italy

Status: Completed

Conditions: Stroke; Stroke Hemorrhagic; Hemiparesis; Hemiplegia; Stroke, Ischemic

Treatments: Device: EMG-biofeedback armband (REMO)

Study type: Interventional

Funder types: Other

Identifiers

NCT04889586

2016.29

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Single ischemic or haemorrhagic stroke;
• Score lower than 100 out of a total of 126 at the Functional Independence Measure (FIM) scale

Exclusion criteria

• Untreated epilepsy;
• Major depressive disorder;
• Fractures;
• Traumatic Brain Injurj;
• Severe Ideomotor Apraxia;
• Severe Neglect;
• Severe impairment of verbal comprehension.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Experimental Group

Experimental group

Description:

The subjects were clinically assessed with a define clinical protocol. After that, the subjects executed the device test with EMG-biofeedback wearable armband.

Treatment:

Device: EMG-biofeedback armband (REMO)