Efficacy of REMO Training for Hand Motor Recovery After Stroke (REMO)
Primary Purpose
Stroke, Stroke, Ischemic, Stroke Hemorrhagic
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
REMO
Task-Oriented Training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Neurological Rehabilitation, Surface Electromyography, Upper Extremity, Motor Impairment, Biofeedback, Motor Recovery
Eligibility Criteria
Inclusion Criteria: Single ischemic or haemorrhagic stroke Fugl-Meyer Upper Extremity score: minimum 10/66 points Exclusion Criteria: Major depressive disorder; Fractures; Traumatic Brain Injury; Severe Ideomotor Apraxia; Severe Neglect; Severe impairment of verbal comprehension.
Sites / Locations
- IRCCS San Camillo HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
REMO training
Task-Oriented training
Arm Description
REMO training will consist of sEMG-biofeedback exercises provided by REMO device.
Task-Oriented training will consist of task-specific functional exercises
Outcomes
Primary Outcome Measures
Fugl-Meyer Upper Extremity - hand
Fugl-Meyer Upper Extremity - hand section is a specific section of Fugl-Meyer Upper Extremity assessment that assesses the wrist and hand motor function in patients with post-stroke hemiplegia. There are 3 values:0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The minimum value is 0. The maximum value is 24 points, which corresponds to normal hand motor function.
Secondary Outcome Measures
Fugl-Meyer Upper Extremity
Fugl-Meyer Upper Extremity is a stroke-specific scale which assesses the upper limb motor functions in patients with post-stroke hemiplegia. There are 3 values:0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The minimum value is 0.
Fugl-Meyer Assessment - 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 Assessment - 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 48points, 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 box 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 (acone). 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 assessor valuates the quality of reaching instead of the grip strength. The minimum value is0 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 to reach an object.
Modified Ashworth Scale - flexor carpi muscles
Level of spasticity of flexor carpi muscles is measured using the Modified Ashworth Scale. 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 insert9 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 level 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.
Action Research Arm Test
Action Research Arm Test (ARAT) assesses upper limb functioning using observational methods. It is a 19 item measure divided into 4 sub-items (grasp, grip, pinch, gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3) Performs test normally; 2) Completes test, but takes abnormally long or has great difficulty; 1) Performs test partially; 0) Can perform no part of test. The maximum score on the ARAT is 57 points (possible range 0 to57).
Cylindric Grasp Force
The Cylindric Grasp Force is assessed with Dynamometer (CITEC Dynamometer, N).
Abilhand questionnaire
The ABILHAND questionnaire assesses bimanual ability as an interview-based test focused on the patient's perceived difficulty. Bimanual ability is defined as the capacity to manage daily activities that require the use of both hands, whatever the strategies involved. Three levels of response scale for each item, rated as 'Impossible=0, Difficult=1, Easy=2, Not applicable=missing data.'.
Abilhand questionnaire
The ABILHAND questionnaire assesses bimanual ability as an interview-based test focused on the patient's perceived difficulty. Bimanual ability is defined as the capacity to manage daily activities that require the use of both hands, whatever the strategies involved. Three levels of response scale for each item, rated as 'Impossible=0, Difficult=1, Easy=2, Not applicable=missing data.'.
System Usability Scale
The System Usability Scale (SUS) provides a reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.
Full Information
NCT ID
NCT05815368
First Posted
March 16, 2023
Last Updated
April 3, 2023
Sponsor
IRCCS San Camillo, Venezia, Italy
1. Study Identification
Unique Protocol Identification Number
NCT05815368
Brief Title
Efficacy of REMO Training for Hand Motor Recovery After Stroke
Acronym
REMO
Official Title
REcovery of Hand Motor Function in Stroke Rehabilitation: Efficacy of a Task-Oriented Protocol Provided by a sEMG-biofeedback Wearable Device (REMO)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2022 (Actual)
Primary Completion Date
January 13, 2024 (Anticipated)
Study Completion Date
January 13, 2024 (Anticipated)
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
Upper limb motor impairment is one of the most common sequelae after stroke. Indeed, the recovery of upper limb sensory-motor functions remains one of the most important goals in stroke rehabilitation.
In the last years, new approaches in neurorehabilitation field has been investigated to enhance motor recovery. The use of wearable devices combined with surface electromyography (i.e. sEMG) electrodes allows to detect patients muscle activation during motor performance. Moreover, sEMG is used to provide to the patients the biofeedback about their muscle activity during exercises execution to enhance motor control and motor recovery. The aim of the study is to define the efficacy of using REMO® (Morecognition srl, Turin,Italy) for hand motor recovery after stroke.
A randomised-controlled trial will be conducted compared to a task-oriented training, in hand motor rehabilitation after stroke. 28 patients with diagnosis of first stroke event will be enrolled in this study. After randomization process, participants will be allocated in Experimental Group (REMO training) or in Control Group (task-oriented training). The participants will be assessed before and after the treatment and sEMG will be collected during 12 hand movements. The treatment will consist of 15 sessions (1h/day, 5day/week, 3 weeks). Finally, the sEMG of the same 12 hand movements will be collected from 15 healthy subjects to compare muscle activation with a normal reference model.
Detailed Description
Stroke is the first cause of permanent disability worldwide. The last American Heart Association (AHA) statistical update showed that in the next years the rate of people affected by stroke is going to increase, most in young people. Indeed, last projections showed that by 2030 an additional 3.4 million adults will have had a stroke, a 20.5% increase in prevalence from 2021. Moreover, upper limb motor impairment is one of the most common sequelae after stroke. The impairment of upper limb motor functions compromises the level of autonomy of the patients in activity of daily living. Thus, the recovery of upper limb sensory-motor functions remains one of the most important goals in stroke rehabilitation.
In the last years, new approaches in neurorehabilitation field have been investigated to enhance motor recovery. The use of wearable devices consist of the application of sensors to the patient's body parts. The advantage of wearable sensor is to collect data from patients' movements to assess motor functions with high level of accuracy. Moreover, wearable device combined with surface electromyography (i.e. sEMG) electrodes allows to detect patients muscle activation during motor performance. sEMG is used also to provide to the patients the biofeedback about their muscle activity during exercises execution to enhance motor control and motor recovery. Surface electromyographic biofeedback showed good results in neurological conditions to improve motor control and hand motor recovery.
The investigators developed a wearable device (REMO®) that collected sEMG from forearm muscles during hand movements. In recent works, the investigators defined the feasibility and security of using REMO in a rehabilitation setting. Moreover, the investigators defined the clinical features of stroke patients able to control the device to execute up to 10 hand movements in order to control a rehabilitation computer interface. The aim of this study is to define the efficacy of using REMO® (Morecognition srl, Turin,Italy) for hand motor recovery after stroke compared to a specific protocol of hand motor rehabilitation (i.e., task-oriented training).
A randomised-controlled trial will be conducted compared to a task-oriented training, in hand motor rehabilitation after stroke. 28 patients with diagnosis of first stroke event, and with no other neurological diagnosis or severe cognitive impairment, will be enrolled in this study. After randomization process, participants will be allocated in Experimental Group (REMO training) or in Control Group (task-oriented training). The participants will be assessed before and after the treatment to define the clinical effects of the hand training. Moreover, the investigators will collect sEMG data using REMO device during 12 hand movements required to the patients before and after the training. The treatment consists of 15 sessions, (1hour/day, for 5 days/week, for 3 weeks). Finally, the sEMG of the same 12 hand movements will be collected from 15 healthy subjects to compare patients' muscle activation with a normal reference model.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke, Ischemic, Stroke Hemorrhagic, Stroke Sequelae
Keywords
Neurological Rehabilitation, Surface Electromyography, Upper Extremity, Motor Impairment, Biofeedback, Motor Recovery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized-Controlled Trial (RCT)
Masking
Outcomes Assessor
Masking Description
Clinical assessments will be performed before and after the treatment by a physical therapist not involved in training and blinded to the purpose and group allocation.
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
REMO training
Arm Type
Experimental
Arm Description
REMO training will consist of sEMG-biofeedback exercises provided by REMO device.
Arm Title
Task-Oriented training
Arm Type
Active Comparator
Arm Description
Task-Oriented training will consist of task-specific functional exercises
Intervention Type
Device
Intervention Name(s)
REMO
Intervention Description
REMO training will consist of sEMG-biofeedback exercises provided by REMO device. The training will be provided 1 hour a day, for 5 days/week, for totally 3 weeks.
Intervention Type
Other
Intervention Name(s)
Task-Oriented Training
Intervention Description
Task-Oriented training will consist of task-specific functional exercises. The training will be provided 1 hour a day, for 5 days/week, for totally 3 weeks.
Primary Outcome Measure Information:
Title
Fugl-Meyer Upper Extremity - hand
Description
Fugl-Meyer Upper Extremity - hand section is a specific section of Fugl-Meyer Upper Extremity assessment that assesses the wrist and hand motor function in patients with post-stroke hemiplegia. There are 3 values:0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The minimum value is 0. The maximum value is 24 points, which corresponds to normal hand motor function.
Time Frame
Change from Baseline Fugl-Meyer Upper Extremity (hand items) at 3 weeks
Secondary Outcome Measure Information:
Title
Fugl-Meyer Upper Extremity
Description
Fugl-Meyer Upper Extremity is a stroke-specific scale which assesses the upper limb motor functions in patients with post-stroke hemiplegia. There are 3 values:0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The minimum value is 0.
Time Frame
Change from Baseline Fugl-Meyer Upper Extremity at 3 weeks
Title
Fugl-Meyer Assessment - 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 Fugl-Meyer Assessment (sensation) at 3 weeks
Title
Fugl-Meyer Assessment - 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 48points, which corresponds to no pain and normal range of motion.
Time Frame
Change from Baseline Fugl-Meyer Assessment (pain and Range of Motion) at 3 weeks
Title
Box and Blocks Test
Description
The patient has to carry as much cubes as possible, one by one, from a box to another one in one minute. The test is performed with both hands.
Time Frame
Change from Baseline Box and Blocks Test at 3 weeks
Title
Reaching Performance Scale
Description
Reaching Performance Scale assesses the ability of subjects to reach an object (acone). 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 assessor valuates the quality of reaching instead of the grip strength. The minimum value is0 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 to reach an object.
Time Frame
Change from Baseline Reaching Performance Scale at 3 weeks
Title
Modified Ashworth Scale - flexor carpi muscles
Description
Level of spasticity of flexor carpi muscles is measured using the Modified Ashworth Scale. 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 Modified Ashworth Scale (flexor carpi muscles) at 3 weeks
Title
Nine Hole Pegboard Test
Description
Nine Hole Pegboard Test measures the dexterity of the hand. Patient should insert9 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 Nine Hole Pegboard Test at 3 weeks
Title
Functional Independence Measure
Description
Functional Independence Measure scale is an 18-item scale that assesses the level 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 Functional Independence Measure at 3 weeks
Title
Action Research Arm Test
Description
Action Research Arm Test (ARAT) assesses upper limb functioning using observational methods. It is a 19 item measure divided into 4 sub-items (grasp, grip, pinch, gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3) Performs test normally; 2) Completes test, but takes abnormally long or has great difficulty; 1) Performs test partially; 0) Can perform no part of test. The maximum score on the ARAT is 57 points (possible range 0 to57).
Time Frame
Change from Baseline Action Research Arm Test at 3 weeks
Title
Cylindric Grasp Force
Description
The Cylindric Grasp Force is assessed with Dynamometer (CITEC Dynamometer, N).
Time Frame
Change from Baseline Cylindric Grasp Force at 3 weeks
Title
Abilhand questionnaire
Description
The ABILHAND questionnaire assesses bimanual ability as an interview-based test focused on the patient's perceived difficulty. Bimanual ability is defined as the capacity to manage daily activities that require the use of both hands, whatever the strategies involved. Three levels of response scale for each item, rated as 'Impossible=0, Difficult=1, Easy=2, Not applicable=missing data.'.
Time Frame
Change from Baseline Abilhand questionnaire at 3 weeks
Title
Abilhand questionnaire
Description
The ABILHAND questionnaire assesses bimanual ability as an interview-based test focused on the patient's perceived difficulty. Bimanual ability is defined as the capacity to manage daily activities that require the use of both hands, whatever the strategies involved. Three levels of response scale for each item, rated as 'Impossible=0, Difficult=1, Easy=2, Not applicable=missing data.'.
Time Frame
Change from Baseline Abilhand questionnaire at 7 weeks
Title
System Usability Scale
Description
The System Usability Scale (SUS) provides a reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.
Time Frame
Immediately after the intervention
Other Pre-specified Outcome Measures:
Title
sEMG activation
Description
The sEMG of forearm muscles will be collected using REMO device.
Time Frame
Change from Baseline sEMG muscle activation at 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Single ischemic or haemorrhagic stroke
Fugl-Meyer Upper Extremity score: minimum 10/66 points
Exclusion Criteria:
Major depressive disorder;
Fractures;
Traumatic Brain Injury;
Severe Ideomotor Apraxia;
Severe Neglect;
Severe impairment of verbal comprehension.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giorgia Pregnolato
Phone
+0412207
Ext
214
Email
giorgia.pregnolato@hsancamillo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giorgia Pregnolato
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giorgia Pregnolato
Phone
+0412207
Ext
214
Email
giorgia.pregnolato@hsancamillo.it
12. IPD Sharing Statement
Citations:
PubMed Identifier
35363499
Citation
Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1. Erratum In: Circulation. 2022 May 3;145(18):e1033. Circulation. 2022 Sep 27;146(13):e185. Circulation. 2023 Apr 4;147(14):e674.
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
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
Citation
D. Rimini et al.,
Results Reference
background
PubMed Identifier
36981992
Citation
Pregnolato G, Rimini D, Baldan F, Maistrello L, Salvalaggio S, Celadon N, Ariano P, Pirri CF, Turolla A. Clinical Features to Predict the Use of a sEMG Wearable Device (REMO(R)) for Hand Motor Training of Stroke Patients: A Cross-Sectional Cohort Study. Int J Environ Res Public Health. 2023 Mar 14;20(6):5082. doi: 10.3390/ijerph20065082.
Results Reference
background
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Efficacy of REMO Training for Hand Motor Recovery After Stroke
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