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

NCT ID: NCT04889586

Last Updated: 2021-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-25
• Study Completion Date: 2019-02-27

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.

Conditions

Stroke; Stroke Hemorrhagic; Stroke, Ischemic; Hemiparesis; Hemiplegia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

EMG-biofeedback armband (REMO)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Camillo, Venezia, Italy

OTHER

Sponsor Role: lead

Responsible Party

Andrea Turolla

Laboratory of Rehabilitation Technologies

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Turolla, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Camillo Hospital

Locations

IRCCS San Camillo Hospital

Venice-Lido, Venice, Italy

Countries

Italy

References

Celadon N, Dosen S, Binder I, Ariano P, Farina D. Proportional estimation of finger movements from high-density surface electromyography. J Neuroeng Rehabil. 2016 Aug 4;13(1):73. doi: 10.1186/s12984-016-0172-3.

Reference Type: BACKGROUND

PMID: 27488270 (View on PubMed)

Dipietro L, Ferraro M, Palazzolo JJ, Krebs HI, Volpe BT, Hogan N. Customized interactive robotic treatment for stroke: EMG-triggered therapy. IEEE Trans Neural Syst Rehabil Eng. 2005 Sep;13(3):325-34. doi: 10.1109/TNSRE.2005.850423.

Reference Type: BACKGROUND

PMID: 16200756 (View on PubMed)

Paleari M, Di Girolamo M, Celadon N, Favetto A, Ariano P. On optimal electrode configuration to estimate hand movements from forearm surface electromyography. Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:6086-9. doi: 10.1109/EMBC.2015.7319780.

Reference Type: BACKGROUND

PMID: 26737680 (View on PubMed)

Pollock A, Farmer SE, Brady MC, Langhorne P, Mead GE, Mehrholz J, van Wijck F. Interventions for improving upper limb function after stroke. Cochrane Database Syst Rev. 2014 Nov 12;2014(11):CD010820. doi: 10.1002/14651858.CD010820.pub2.

Reference Type: BACKGROUND

PMID: 25387001 (View on PubMed)

Other Identifiers

2016.29

Identifier Type: -

Identifier Source: org_study_id