Effects of Hand MOtor Rehabilitation Using a sEMG-biofeedback

NCT05416619 | Completed DMC

• 1 other identifier: 2016.29.1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is the first cause of disability worldwide. The motor impairment of the hand is one of the most common sequelae in patients after stroke. Indeed, approximately 60% of patients with diagnosis of stroke suffers from hand sensorimotor impairment. In the last years, new approaches in neurorehabilitation field has been permitted to enhance hand motor recovery. Wearable devices permit to apply sensors to the patient's body for monitoring the kinematic and dynamic characteristics of patient's motion. Moreover, wearable sensors combined with electrodes detecting muscle activation (i.e. surface electromyography - sEMG) permit to provide biofeedback to the patient to improve motor recovery.

Conditions

Stroke; Stroke, Ischemic; Stroke Hemorrhagic; Hemiparesis

Keywords

Neurological Rehabilitation; Hand Recovery; Electromyography

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Upper Extremity

  Fugl-Meyer Upper Extremity is a stroke-specific scale which assesses the upper limb motor functioning in patients with post-stroke hemiplegia. There are 3 values: 0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The minimum value is 0 points, which corresponds to upper limb hemiplegia. The maximum value is 66 points, which corresponds to normal motor performance.

  Change from baseline, at 3 weeks (15 sessions).

Secondary Outcomes (8)

• Fugl-Meyer - sensation

  Change from baseline, at 3 weeks (15 sessions).

• Fugl-Meyer - pain and Range of Motion

  Change from baseline, at 3 weeks (15 sessions).

• Box and Blocks Test

  Change from baseline, at 3 weeks (15 sessions).

• Reaching Performance Scale

  Change from baseline, at 3 weeks (15 sessions).

• Modified Ashworth Scale

  Change from baseline, at 3 weeks (15 sessions).

Study Arms (1)

sEMG-biofeedback Group

EXPERIMENTAL

Receive 1 hour of sEMG-biofeedback hand training provided by wearable REMO® and 1 hour of daily conventional rehabilitation therapy.

Device: REMO®

Interventions

REMO® DEVICE

The patients receive daily 1 hour of conventional therapy and 1 hour of treatment of REMO®, that is a wearable composed by 8 bipolar electrodes able to detect the surface electromyography of the forearm muscles. REMO® allows the control of a computer interface using the surface electromyography to execute sEMG-biofeedback exercises for hand rehabilitation. The movements required for hand rehabilitation are the following: thumb abduction, pinch, finger flexion, finger extension, wrist flexion, wrist extension, forearm pronation, forearm supination, radial wrist deviation and ulnar wrist deviation. The treatment consists in 15 sessions, 1hour/day, for 5 days/week, for 3 weeks. The patients are clinically evaluated before and after the REMO® treatment.

sEMG-biofeedback 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
• able to control at least 1 movement with REMO (i.e. able to cross 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)

You may not qualify if:

• Untreated epilepsy;
• Major depressive disorder;
• Fractures;
• Traumatic Brain Injury;
• 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 (5)

• 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

• 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

• Di Girolamo M, Celadon N, Appendino S, Turolla A. and Ariano P. EMG-based biofeedback system for motor rehabilitation: A pilot study,. IEEE Biomedical Circuits and Systems Conference (BioCAS). 2017; pp. 1-4, doi: 10.1109/BIOCAS.2017.8325086.

  BACKGROUND

• Parker J, Powell L, Mawson S. Effectiveness of Upper Limb Wearable Technology for Improving Activity and Participation in Adult Stroke Survivors: Systematic Review. J Med Internet Res. 2020 Jan 8;22(1):e15981. doi: 10.2196/15981.

  PMID: 31913131 BACKGROUND

• Maceira-Elvira P, Popa T, Schmid AC, Hummel FC. Wearable technology in stroke rehabilitation: towards improved diagnosis and treatment of upper-limb motor impairment. J Neuroeng Rehabil. 2019 Nov 19;16(1):142. doi: 10.1186/s12984-019-0612-y.

  PMID: 31744553 BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Paresis

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

Study Officials

• Andrea Turolla, PhD

  IRCCS San Camillo Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Intervention is provided by a wearable device for hand rehabilitation. The device is composed by 8 bipolar electrodes that are able to detect muscle activation to control a computer interface to execute sEMG-biofeedback training for hand motor recovery.

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 13, 2022
• Study Start: August 14, 2017
• Primary Completion: February 11, 2019
• Study Completion: February 27, 2019
• Last Updated: June 13, 2022

Record last verified: 2022-06

Locations

IT (1)