search
Back to results

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

Primary Purpose

Stroke, Stroke Hemorrhagic, Stroke, Ischemic

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
EMG-biofeedback armband (REMO)
Sponsored by
IRCCS San Camillo, Venezia, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Stroke focused on measuring Neurological Rehabilitation, Upper Extremity, Electromyography, Hand Gesture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IRCCS San Camillo Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Group

Arm Description

The subjects were clinically assessed with a define clinical protocol. After that, the subjects executed the device test with EMG-biofeedback wearable armband.

Outcomes

Primary Outcome Measures

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)

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 impairiment), 2 (preserved function)
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)
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.
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).
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).
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.
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).
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).

Full Information

First Posted
May 6, 2021
Last Updated
May 14, 2021
Sponsor
IRCCS San Camillo, Venezia, Italy
search

1. Study Identification

Unique Protocol Identification Number
NCT04889586
Brief Title
Hand MOtor Rehabilitation Using a EMG-biofeedback: a Cross-sectional Study
Acronym
MORE
Official Title
Hand Motor Recovery Using a EMG-biofeedback in Stroke Rehabilitation: a Cross-sectional Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 25, 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
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke Hemorrhagic, Stroke, Ischemic, Hemiparesis, Hemiplegia
Keywords
Neurological Rehabilitation, Upper Extremity, Electromyography, Hand Gesture

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Each subject is assessed with a clinical protocol and an instrumental test, consists in executing 10 hand gestures by wearing a EMG-biofeedback armband
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The subjects were clinically assessed with a define clinical protocol. After that, the subjects executed the device test with EMG-biofeedback wearable armband.
Intervention Type
Device
Intervention Name(s)
EMG-biofeedback armband (REMO)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fugl-Meyer Upper Extremity (FMA-UE)
Description
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)
Time Frame
within 1 week from enrolment.
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 impairiment), 2 (preserved function)
Time Frame
within 1 week from enrolment.
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 impairiment), 2 (preserved function)
Time Frame
within 1 week from enrolment.
Title
Box and Blocks Test (BBT)
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
within 1 week from enrolment.
Title
Reaching Performance Scale (RPS)
Description
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).
Time Frame
within 1 week from enrolment.
Title
Modified Ashworth Scale (MAS)
Description
Spasticity is measured using the MAS of five muscles: Pectoralis major, biceps, wrist flexors, flexor digitorum superficialis, flexor digitorum profundus (Total score = 20 points).
Time Frame
within 1 week from enrolment.
Title
Nine Hole Pegboard Test (NHPT)
Description
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.
Time Frame
within 1 week from enrolment.
Title
Functional Independence Measure scale (FIM)
Description
FIM is an 18-item scale that assesses the degree of autonomy in carrying out activities of daily living (total score = 126 points).
Time Frame
within 1 week from enrolment.
Title
Number of movements controlled by EMG-biofeedback 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 EMG recording during baseline (i.e. rest position).
Time Frame
within 1 week from enrolment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
16200756
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. doi: 10.1109/TNSRE.2005.850423.
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
PubMed Identifier
25387001
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;2014(11):CD010820. doi: 10.1002/14651858.CD010820.pub2.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs