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

Stroke Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04889586
• Other study ID #: 2016.29
• Status: Completed
• Phase: N/A
• Start date: July 25, 2017
• Est. completion date: February 27, 2019

Study information

• Verified date: May 2021
• Source: IRCCS San Camillo, Venezia, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 27, 2019
• Est. primary completion date: February 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS San Camillo Hospital	Venice-Lido	Venice

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Camillo, Venezia, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Celadon N, Došen 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. — View Citation

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. — View Citation

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. — View Citation

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;(11):CD010820. doi: 10.1002/14651858.CD010820.pub2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Upper Extremity (FMA-UE)	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)	within 1 week from enrolment.
Secondary	Fugl-Meyer - sensation	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)	within 1 week from enrolment.
Secondary	Fugl-Meyer - pain and Range of Motion	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)	within 1 week from enrolment.
Secondary	Box and Blocks Test (BBT)	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.	within 1 week from enrolment.
Secondary	Reaching Performance Scale (RPS)	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).	within 1 week from enrolment.
Secondary	Modified Ashworth Scale (MAS)	Spasticity is measured using the MAS of five muscles: Pectoralis major, biceps, wrist flexors, flexor digitorum superficialis, flexor digitorum profundus (Total score = 20 points).	within 1 week from enrolment.
Secondary	Nine Hole Pegboard Test (NHPT)	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.	within 1 week from enrolment.
Secondary	Functional Independence Measure scale (FIM)	FIM is an 18-item scale that assesses the degree of autonomy in carrying out activities of daily living (total score = 126 points).	within 1 week from enrolment.
Secondary	Number of movements controlled by EMG-biofeedback device	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).	within 1 week from enrolment.