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

NCT04889586 | Completed DMC

• 1 other identifier: 2016.29
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Neurological Rehabilitation; Upper Extremity; Electromyography; Hand Gesture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Fugl-Meyer - sensation

  within 1 week from enrolment.

• Fugl-Meyer - pain and Range of Motion

  within 1 week from enrolment.

• Box and Blocks Test (BBT)

  within 1 week from enrolment.

• Reaching Performance Scale (RPS)

  within 1 week from enrolment.

• Modified Ashworth Scale (MAS)

  within 1 week from enrolment.

Study Arms (1)

Experimental Group

EXPERIMENTAL

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)

Interventions

EMG-biofeedback armband (REMO) 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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead

Study Sites (1)

IRCCS San Camillo Hospital

Venice-Lido, Venice, 30126, Italy

Location

Related Publications (4)

• 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.

  PMID: 27488270 BACKGROUND

• 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.

  PMID: 16200756 BACKGROUND

• 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.

  PMID: 26737680 BACKGROUND

• 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.

  PMID: 25387001 BACKGROUND

MeSH Terms

Conditions

Stroke; Hemorrhagic Stroke; Ischemic Stroke; Paresis; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Study Officials

• Andrea Turolla, PhD

  IRCCS San Camillo Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Laboratory of Rehabilitation Technologies

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

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 17, 2021
• Study Start: July 25, 2017
• Primary Completion: February 11, 2019
• Study Completion: February 27, 2019
• Last Updated: May 17, 2021

Record last verified: 2021-05

Locations

IT (1)