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

Sponsor

IRCCS San Camillo, Venezia, Italy (Other)

Overall Status

Completed

CT.gov ID

NCT04889586

Collaborator

(none)

100

Enrollment

Location

Arm

19.1

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Stroke Hemorrhagic Stroke, Ischemic Hemiparesis Hemiplegia	Device: EMG-biofeedback armband (REMO)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Each subject is assessed with a clinical protocol and an instrumental test, consists in executing 10 hand gestures by wearing a EMG-biofeedback armbandEach subject is assessed with a clinical protocol and an instrumental test, consists in executing 10 hand gestures by wearing a EMG-biofeedback armband

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Jul 25, 2017

Actual Primary Completion Date :

Feb 11, 2019

Actual Study Completion Date :

Feb 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group The subjects were clinically assessed with a define clinical protocol. After that, the subjects executed the device test with EMG-biofeedback wearable armband.	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.

Arm

Intervention/Treatment

Experimental: Experimental Group

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

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.

Outcome Measures

Primary Outcome Measures

Fugl-Meyer Upper Extremity (FMA-UE) [within 1 week from enrolment.]
Motor function of the upper limb is measured by means of the Fugl-Meyer Scale. There are 3 values: 0 (severe impairment), 1 (moderate impairiment), 2 (preserved function)

Secondary Outcome Measures

Fugl-Meyer - sensation [within 1 week from enrolment.]
Sensation of the hemiparetic side is measured by means of the Fugl-Meyer Scale. There are 3 values: 0 (severe impairment), 1 (moderate impairiment), 2 (preserved function)
Fugl-Meyer - pain and Range of Motion [within 1 week from enrolment.]
Pain and Range of Motion of the hemiparetic upper limb is measured by means of the Fugl-Meyer Scale. There are 3 values: 0 (severe impairment), 1 (moderate impairiment), 2 (preserved function)
Box and Blocks Test (BBT) [within 1 week from enrolment.]
The patient has to carry as much cubes as possible, one by one, from a container to another one in one minute. The test is performed with both hands.
Reaching Performance Scale (RPS) [within 1 week from enrolment.]
RPS assesses the ability of subjects to reach an object (a cone). The cone is placed at both 4-cm (close) and 30-cm (far) distance from the subject. The subject is asked to reach and grab the cone if possible. The observer evaluates the quality of reaching instead of the grip strength (Total score = 36 points).
Modified Ashworth Scale (MAS) [within 1 week from enrolment.]
Spasticity is measured using the MAS of five muscles: Pectoralis major, biceps, wrist flexors, flexor digitorum superficialis, flexor digitorum profundus (Total score = 20 points).
Nine Hole Pegboard Test (NHPT) [within 1 week from enrolment.]
NHPT measures the dexterity of the hand. Patient should insert 9 pins in the board. There are 9 pins. The number of pins inserted in 50 sec are registered or if the patient inserted 9 pins, then the time is registered.
Functional Independence Measure scale (FIM) [within 1 week from enrolment.]
FIM is an 18-item scale that assesses the degree of autonomy in carrying out activities of daily living (total score = 126 points).
Number of movements controlled by EMG-biofeedback device [within 1 week from enrolment.]
The patient is able to control a movement with the device if he crosses the pre-defined empirical threshold (10%) of the ratio between the maximum voluntary contraction (MVC) of the movement and the EMG recording during baseline (i.e. rest position).