Clinical trial NCT05416619: Effects of Hand MOtor Rehabilitation Using a sEMG-biofeedback
Official title: Effects of Hand MOtor Rehabilitation Using a sEMG-biofeedback, After Stroke: a Longitudinal Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Stroke, Ischemic
Stroke Hemorrhagic
Hemiparesis
Keywords: Neurological Rehabilitation
Hand Recovery
Electromyography
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: The aim of the study is to investigate the effect of using REMO® (Morecognition srl, Turin, Italy) device in hand motor rehabilitation.

The device REMO® is 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 sEMG-biofeedback exercises in stroke rehabilitation training. The device is developed by clinicians of IRCCS San Camillo Hospital and Morecognition Srl.

A total of 20 patients with first diagnosis of stroke and with no other neurological diagnosis or severe cognitive impairment has been enrolled. The patients are tested with REMO® and if they are able to control at least one movements, they are enrolled in the longitudinal pilot study. 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 to define clinical effect of the sEMG-biofeedback training.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: Fugl-Meyer Upper Extremity
timeFrame: Change from baseline, at 3 weeks (15 sessions).
Secondary outcomes:
measure: Fugl-Meyer - sensation
timeFrame: Change from baseline, at 3 weeks (15 sessions).
measure: Fugl-Meyer - pain and Range of Motion
timeFrame: Change from baseline, at 3 weeks (15 sessions).
measure: Box and Blocks Test
timeFrame: Change from baseline, at 3 weeks (15 sessions).
measure: Reaching Performance Scale
timeFrame: Change from baseline, at 3 weeks (15 sessions).
measure: Modified Ashworth Scale
timeFrame: Change from baseline, at 3 weeks (15 sessions).
measure: Nine Hole Pegboard Test
timeFrame: Change from baseline, at 3 weeks (15 sessions).
measure: Functional Independence Measure
timeFrame: Change from baseline, at 3 weeks (15 sessions).
measure: Number of movements controlled by REMO® device
timeFrame: Change from baseline, at 3 weeks (15 sessions).
Other outcomes:
Locations:
city: Venice-Lido
country: Italy
facility: IRCCS San Camillo Hospital
state: Venice
Study officials:
affiliation: IRCCS San Camillo Hospital
name: Andrea Turolla, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.
citation: 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.
citation: 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.