Effects of Hand MOtor Rehabilitation Using a sEMG-biofeedback (MORE)
Primary Purpose
Stroke, Stroke, Ischemic, Stroke Hemorrhagic
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
REMO®
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Neurological Rehabilitation, Hand Recovery, Electromyography
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.
Sites / Locations
- IRCCS San Camillo Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
sEMG-biofeedback Group
Arm Description
Receive 1 hour of sEMG-biofeedback hand training provided by wearable REMO® and 1 hour of daily conventional rehabilitation therapy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 impairment), 2 (preserved function). The minimum value is 0 points, which corresponds to completely impaired sensory functioning. The maximum value is 24 points, which corresponds to normal sensory functioning.
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 impairment), 2 (preserved function). The minimum value is 0 points, which corresponds to maximum level of pain and restriction. The maximum value is 48 points, which corresponds to no pain and normal range of motion.
Box and Blocks Test
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.
Reaching Performance Scale
Reaching Performance Scale 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. The minimum value is 0 points, which corresponds to incapacity of any ability of reaching an object. The maximum value is 36 points, which corresponds to the preservation of the ability of reaching an object.
Modified Ashworth Scale
Spasticity is measured using the Modified Ashworth Scale of five muscles: Pectoralis major, biceps, wrist flexors, flexor digitorum superficialis, flexor digitorum profundus (Total score = 20 points). The therapist evaluates the spasticity of each muscles. There are 5 values: 0 (no increase in muscle tone), 1 (slight increase in muscle tone), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone), 4 (affected part rigid in flexion or extension).
Nine Hole Pegboard Test
Nine Hole Pegboard Test 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.
Functional Independence Measure
Functional Independence Measure scale is an 18-item scale that assesses the degree of independence in carrying out activities of daily living. There are 7 values: 1 (Total Assistance or not Testable), 2 (Maximal Assistance), 3 (Moderate Assistance), 4 (Minimal Assistance), 5 (Supervision), 6 (Modified Independence), 7 (Complete Independence). The minimum values is 18 points, which corresponds to the lower level of independence in activities of daily living. The maximum value is 126 points, which corresponds to the maximum level of independence in activities of daily living.
Number of movements controlled by REMO® 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 sEMG recording during baseline (i.e. rest position).
Full Information
NCT ID
NCT05416619
First Posted
May 31, 2022
Last Updated
June 8, 2022
Sponsor
IRCCS San Camillo, Venezia, Italy
1. Study Identification
Unique Protocol Identification Number
NCT05416619
Brief Title
Effects of Hand MOtor Rehabilitation Using a sEMG-biofeedback
Acronym
MORE
Official Title
Effects of Hand MOtor Rehabilitation Using a sEMG-biofeedback, After Stroke: a Longitudinal Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 14, 2017 (Actual)
Primary Completion Date
February 11, 2019 (Actual)
Study Completion Date
February 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Camillo, Venezia, Italy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke, Ischemic, Stroke Hemorrhagic, Hemiparesis
Keywords
Neurological Rehabilitation, Hand Recovery, Electromyography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sEMG-biofeedback Group
Arm Type
Experimental
Arm Description
Receive 1 hour of sEMG-biofeedback hand training provided by wearable REMO® and 1 hour of daily conventional rehabilitation therapy.
Intervention Type
Device
Intervention Name(s)
REMO®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fugl-Meyer Upper Extremity
Description
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.
Time Frame
Change from baseline, at 3 weeks (15 sessions).
Secondary Outcome Measure Information:
Title
Fugl-Meyer - sensation
Description
Sensation of the hemiparetic side is measured by means of the Fugl-Meyer Scale. There are 3 values: 0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The minimum value is 0 points, which corresponds to completely impaired sensory functioning. The maximum value is 24 points, which corresponds to normal sensory functioning.
Time Frame
Change from baseline, at 3 weeks (15 sessions).
Title
Fugl-Meyer - pain and Range of Motion
Description
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 impairment), 2 (preserved function). The minimum value is 0 points, which corresponds to maximum level of pain and restriction. The maximum value is 48 points, which corresponds to no pain and normal range of motion.
Time Frame
Change from baseline, at 3 weeks (15 sessions).
Title
Box and Blocks Test
Description
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.
Time Frame
Change from baseline, at 3 weeks (15 sessions).
Title
Reaching Performance Scale
Description
Reaching Performance Scale 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. The minimum value is 0 points, which corresponds to incapacity of any ability of reaching an object. The maximum value is 36 points, which corresponds to the preservation of the ability of reaching an object.
Time Frame
Change from baseline, at 3 weeks (15 sessions).
Title
Modified Ashworth Scale
Description
Spasticity is measured using the Modified Ashworth Scale of five muscles: Pectoralis major, biceps, wrist flexors, flexor digitorum superficialis, flexor digitorum profundus (Total score = 20 points). The therapist evaluates the spasticity of each muscles. There are 5 values: 0 (no increase in muscle tone), 1 (slight increase in muscle tone), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone), 4 (affected part rigid in flexion or extension).
Time Frame
Change from baseline, at 3 weeks (15 sessions).
Title
Nine Hole Pegboard Test
Description
Nine Hole Pegboard Test 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.
Time Frame
Change from baseline, at 3 weeks (15 sessions).
Title
Functional Independence Measure
Description
Functional Independence Measure scale is an 18-item scale that assesses the degree of independence in carrying out activities of daily living. There are 7 values: 1 (Total Assistance or not Testable), 2 (Maximal Assistance), 3 (Moderate Assistance), 4 (Minimal Assistance), 5 (Supervision), 6 (Modified Independence), 7 (Complete Independence). The minimum values is 18 points, which corresponds to the lower level of independence in activities of daily living. The maximum value is 126 points, which corresponds to the maximum level of independence in activities of daily living.
Time Frame
Change from baseline, at 3 weeks (15 sessions).
Title
Number of movements controlled by REMO® device
Description
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 sEMG recording during baseline (i.e. rest position).
Time Frame
Change from baseline, at 3 weeks (15 sessions).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Turolla, PhD
Organizational Affiliation
IRCCS San Camillo Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS San Camillo Hospital
City
Venice-Lido
State/Province
Venice
ZIP/Postal Code
30126
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
27488270
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.
Results Reference
background
PubMed Identifier
26737680
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
31913131
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.
Results Reference
background
PubMed Identifier
31744553
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.
Results Reference
background
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Effects of Hand MOtor Rehabilitation Using a sEMG-biofeedback
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