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CTRI Number  CTRI/2024/10/075635 [Registered on: 22/10/2024] Trial Registered Prospectively
Last Modified On: 21/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Impact of task oriented training on assessing with electrical muscle stimulation to improve hand function in post stroke patients 
Scientific Title of Study   Effects of task oriented training on assessing with electrical muscle stimulation to improve hand function in post stroke patients- A randomized control trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anuradha Vyankatrao Shinde 
Designation  UG Student 
Affiliation  Pravara Institute of medical sciences loni 
Address  Dr APJ Abdul Kalam College Of Physiotherapy, pravara institute of medical sciences Loni Ahemadnagar Maharashtra 413736 India
Neuro physiotherapy department 303 third floor Dr.APj Abdul Kalam college of physiotherapy
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9021800929  
Fax    
Email  anushinde1011@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shyam Kurapati  
Designation  Head of department, Department of Neuro Physiotherapy 
Affiliation  Dr APJ Abdul Kalam College Of physiotherapy Loni 
Address  Neuro physiotherapy department, OPD no. 303, third floor Dr APJ Abdul Kalam College Of physiotherapy Loni Ahmadnagar MAHARASHTRA 413736 India
Neurophysiotheraphy department of Dr.APJ Abdul Kalam college of physiotherapy
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8978438484  
Fax    
Email  kurapatishyam82@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anuradha Vyankatrao Shinde 
Designation  Undergraduate student 
Affiliation  Dr APJ Abdul Kalam College Of physiotherapy Loni 
Address  Dr APJ Abdul Kalam College Of physiotherapy Loni Ahmadnagar MAHARASHTRA 413736 India
Neuro physiotherapy department 303 third floor Dr APJ Abdul Kalam college of physiotherapy
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9021800929  
Fax    
Email  anushinde1011@gmail.com  
 
Source of Monetary or Material Support  
Pravara institute of medical sciences, Loni, Ahemadnagar, 413736 
 
Primary Sponsor  
Name  Dr APJ Abdul Kalam College Of Physiotherapy ,PIMS ,Loni 
Address  Pravara Institute Of Medical Sciences,Dr APJ Abdul Kalam College Of PhysiOtherapy, Loni 413736 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shyam kurapati  Pravara Medical trust  Neuro physiotherapy Department 303 third floor loni
Ahmadnagar
MAHARASHTRA 
8978438484

kurapatishyam82@gmail.com 
Dr Shyam kurapati  Pravara Medical trust  Neuro physiotherapy department 303 third floor Dr APJ Abdul Kalam College of physiotherapy
Ahmadnagar
MAHARASHTRA 
8978438484

kurapatishyam82@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  group b task oriented training  Grasping a glass Cylindrical and instructed to lift up glass from the start position ,reach forward then place down at the full arm length position Grasping a bottle(cylindrical) and instructed to lift up bottle from the start position, reach forward then place down at the full arm length position Grasping a ball(cricket,spherical ball),(7.5cm diameter) and touching a target line Grasping a block (5 cm cube ) and touching a target line Grasping a bowl 27cm diameter, weight 300gm and touching target line Placing coins in box Lifting a 3lb basket and placing it on a table Moving pipes in target line (2 Different size) Using pincer grasp turns key 180 degrees left and right  
Comparator Agent  task oriented exercises with electrical muscle stimulation  task oriented exercises with electrical muscle stimulation Duration of protocol 5days/week for 6 weeks Electrical Stimulation: Faradic current Time 30 min Frequency -50 to 100HZ 10 to 15 repetitions Pulse width-200µs  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients who are willingly participate
2)Diagnosed with MCA stroke
 
 
ExclusionCriteria 
Details  1)Patients with perceptual and cognitive deficits
2)Patients with recent surgery of upper limb
4)Patient with other neurological problem
5)Patient with recurrence history of stroke

 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1) Box and block test
2)wolf motor function test 
6Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Electrical muscle stimulation  week 0 to week 6 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Introduction:

About 50% of stroke survivors have impairments in their ability to use their arms and hands, sometimes for the remainder of their lives. In the upcoming decades, arm-hand performance issues are projected to become more common due to rising stroke incidence and prevalence. This will put a significant strain on the healthcare system.[1]

Proficiency in dexterity skills—the capacity to grasp and operate items with precise and coordinated hand and finger movements—is intimately linked to independence in daily life activities. Following a stroke, hand and finger control is frequently more compromised and more difficult to regain than proximal upper extremity ability, despite their significant correlation.. It was proposed that the ipsilateral corticospinal and reticulospinal pathways have a greater capacity to make up for the motor deficiencies of the limb’s proximal muscles as opposed to its distal muscles. This case study illustrates the effective functional recovery of the upper limb’s proximal and distal motor skills following a stroke.[2]

Hemiparetic stroke patients may see correlated functional changes and an increase in the size of the cortical areas representing their upper extremities when they receive repetitive, task-specific, paretic upper extremity practice (RTP).

According to a recent study by Dettmers et al. , following an RTP training routine for three hours a day for twenty workdays decreased paretic upper extremity impairment and improved function. RTP regimens, however, frequently call for extensive therapy sessions, the home restriction of the nonparetic upper extremity, and/or no reimbursement. Active wrist and finger extension was also necessary to complete this program, which presents a hurdle for the majority of stroke survivors[4]

The character of the functional recovery highlights the significance of following the principles of motor learning in order to assist the intrinsic neurological recovery. These principles include rigorous training, which involves using task-specific exercises9 and difficult exercises 10 within a practice variability of . It has been previously documented that a task-oriented treatment (TOT) based on these principles is superior to standard physical or occupational therapy administered with the same intensity and duration, as well as to classic neurodevelopmental approaches. When compared to resistive exercise training, Thielman et al. observed superior reaching performance and a better reaching trajectory with TOT. However, other trials found very slight improvements above standard treatment or a placebo, or non-significant changes in outcomes between TOT and standard occupational therapy[3]

The most frequent cause of permanent impairment is stroke. Early post-stroke impaired balance is highly correlated with subsequent function and recovery. The greatest risk factor for falls among chronic stroke patients who live at home is balance issues, particularly while performing difficult chores. Furthermore,  found a correlation between a history of falls and depressive symptoms, fall-related self-efficacy, and fear of falling in people with chronic stroke. They also discovered that having a history of falls was linked to having poor balance. Fear of falling can contribute to a sedentary lifestyle and decreased activity, which worsens function and health (the vicious circle of incapacity). Since attaining functional recovery after a stroke is frequently dependent on therapy, rehabilitation researchers and doctors[5] After a stroke, the task-oriented training strategy has been shown to be successful in improving skilled arm-hand performance and to fit the training preferences of the patient.[1] The term "task-oriented training" is still not well defined. Legg et al. (2009) note that the precise definition of an effective intervention in occupational therapy is ill-defined, and this also applies to task-oriented training in particular. Research on "task training" for the upper limb following a stroke employ varying levels of intensity and duration of intervention, and these include[1]

Acute cerebrovascular accident (stroke) is a neurological condition characterized by abrupt loss of consciousness and paralysis due to the blockage or rupture of brain blood vessels. Functional motor disorders of the upper limbs include muscular weakness. unusual tone in the muscles stroke survivors experience aberrant eye movement, coordination deficits, and altered muscular tone when performing tasks like holding and releasing.[6] Intracerebral bleeding or vascular blockage, such as hypoxia, ischemia, or infarction, are the two main causes of stroke.


The form that occurs most frequently is cerebral infarction.
This has to do with the fact that the central nervous system is extremely vulnerable to ischemia or low oxygen levels in different body organs1. Patients who have had a stroke typically have aberrant muscular tension, motor paralysis2, muscle weakness, and coordination issues. Patients who have had strokes and are experiencing these neurological symptoms have difficulties in their social, mental, and physical functioning; of these, 40% have some malfunction and 15–30% have sensory issues.[7] In real life, both hands are used to accomplish a lot of tasks. Even in patients with severe upper limb paralysis, performance may be improved by repetitive, identical tasks performed on a regular basis. Using both hands during therapy improves the functional ability of the affected side upper limb, which helps stroke patients with their rehabilitation and day-to-day tasks.[7]

Electrical stimulation (ES) may improve motor function through a number of methods, including increased excitability in the somatosensory area (S1), premotor, and contralateral primary motor area.[8]

 

NEED FOR THE STUDY:

·       Stroke is the one of the main cause for impairment or decrease in functional mobility many studies have proven effectiveness of various techniques to improve hand functions in patients with stroke.

 

·       There is lack of studies to improve hand functions in subjects with stroke by using electrical muscle stimulation along with effect task oriented training so the need of this study is to find out the effect of task oriented training with electrical muscle stimulation on hand function in patient with stroke.

 

RESEARCH QUESTION:

Will there be effect  of task oriented training with electrical muscle stimulation to improve  hand function in stroke patients? 

AIM:

 To find out the effectiveness in improving hand function in subjects with stroke by using electrical muscle stimulation and task oriented training.

OBJECTIVE OF THE STUDY:

To find out the effectiveness of electrical muscle stimulation along with task oriented training in improving hand function of subjects with stroke.

To compare the effectiveness of electrical muscle stimulation along with task oriented training in improving hand function of subject with stroke.

REVIEW OF LITERATURE:

1.     Herman kingama et.al 2010 conducted study on the  This review analyzes the fundamental training elements that are currently employed in task-oriented training and determines how these elements affect stroke patients’ ability to perform competent arm-hand tasks. Fifteen components made up the operationalization of the task-oriented training. The posttreatment impact size was not correlated with the number of components utilized in an intervention designed to improve arm-hand performance following a stroke. In studies with greater treatment benefits, specific components that maximize the long-term memory storage of taught motor performance happened more frequently. The included trials made use of components. The amount of task-oriented training components used in a study and the extent of the treatment effect were uncorrelated. The two terms that had the biggest postintervention effect sizes were "feedback" and "distributed practice". The biggest follow-up effect sizes were linked to "random practice" and "use of clear functional goals".

 

2.      Samantha Maslyn et.al 2009 conducted study on  To ascertain how an activity-specific electrical stimulation program affects a subacute stroke patient who shows little paretic wrist and hand mobility in terms of paretic limb disability, functional limitation, and capacity to do valued activities. Nine months following a stroke, a female participant with trace paretic hand and finger mobility underwent administration of the Fugl-Meyer Impairment Scale (FM) upper extremity component, the Action Research Arm Test (ARAT), and the Arm Motor Ability Test (AMAT). After that, she trained for certain tasks using an electrical stimulation neuroprosthesis in her paretic upper extremities. For three weeks, there was three hours of training every day, five days a week. Once more, the FM, ARAT, and AMAT were given out. She showed decreased functional limitation (shown by an ARAT score change of 4 to 10) and decreased impairment (shown by an FM score change of 22 to 29) following the intervention. She also demonstrated improved skill and speed in completing important AMAT tasks. She also mentioned employing her newfound skills to complete important tasks like playing the piano and using her paretic hand and fingers more.
In conclusion, electrical stimulation training with a neuroprosthesis looks promising, even though traditional paretic upper extremity training procedures are ineffective in patients at this level.

3.      Steven L.Wolf et.al 2016 conducted study on effect of a task oriented rehabilitation programme on upper extremity on motor stroke Higher dosages of task-oriented training appear to be preferable to current therapeutic practice for stroke patients with motor impairments in the upper extremities, according to clinical trials. To assess the effectiveness of normal and customary occupational therapy (UCC) vs an organized, task-oriented motor training program during the recovery process following a stroke. Three types of occupational therapy were used: dose-equivalent occupational therapy (DEUCC; n = 120); monitoring-only occupational therapy (UCC; n = 122); and structured, task-oriented upper extremity training (Accelerated Skill Acquisition Program [ASAP]; n = 119). The UCC group received dose-specific monitoring only; the DEUCC group was prescribed 30 one-hour sessions spread over a period of 10 weeks. A 12-month change in the log-transformed Wolf Motor Function Test time score (WMFT, which is based on an average of 15 timed arm movements and hand dexterity tasks) was the main outcome. The proportion of patients improving by at least 25 points on the Stroke Impact Scale (SIS) hand function score (MCID = 17.8 points) and the improvement in the WMFT time score (minimum clinically significant difference [MCID] = 19 seconds) were the secondary outcomes.

                 

4.     4.Johan Anton Franck,et.al 2017 Jun 14 Programs for arm-hand rehabilitation used in stroke recovery often focus on a particular population, making them less useful for patient populations that are more diverse. Furthermore, evaluations of the alterations in arm-hand function (AHF) and arm-hand skill performance (AHSP) both during and following a particular, well-described rehabilitation treatment are frequently lacking.Three subgroups of stroke patients with either a severely, moderately, or mildly impaired AHF were included in this single-armed prospective cohort study. Concise Arm and Hand Rehabilitation Approach in Stroke (CARAS) was the rehabilitation method prescribed. Function and activity level measurements were taken at the time of admission, at the clinical discharge, and three, six, nine, and twelve months later.Ninety-nine stroke patients (M/F:63/23; mean age: 576 years plus or minus 0.6; time after stroke: 29.8 days plus or minus 2.1) took part. AHF and arm-hand capacity increased in all patients both during and after rehabilitation, with the severely damaged category showing the greatest improvement in grip strength. Patients with a mildly impaired AHF showed the largest benefits. All subgroups had an average improvement in their self-perceived AHSP over time. Regarding their perception of their own AHSP after rehabilitation, a tiny proportion of patients deteriorated.

5.     Kyoungsim Jung et.al 2017  In this study, upper limb muscle activation in chronic stroke survivors with mild to moderate paresis was examined in relation to the effectiveness of Task-Related Training (TRT) Combined with Transcutaneous Electrical Nerve Stimulation (TENS).

A randomized, single-blind clinical trial including 46 stroke survivors who had chronic paresis was carried out. Two groups were assigned at random: one was TRT+TENS (n = 23) and the other was TRT+placebo TENS (TRT+PLBO) (n = 23). While the TRT+PLBO group received placebo TENS, which was not actual ES, the TRT+TENS group received high-frequency TENS on wrist and elbow extensors for 30 minutes. Both groups performed TRT for 30 minutes following TENS administration. For four weeks, the intervention was administered five days a week. Integrated EMG (IEMG), a digital manual muscle tester for muscle strength, active range of motion (AROM), and Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) were used to quantify the key outcomes of upper limb muscle activation. Both before and after the four-week intervention, the measures were taken.

6.     Sun-Ho Kim et.al  2016 Jun;  The current study set out to examine how upper extremity function in chronic stroke patients was affected by the combination of task-oriented training (TOT) and electromyogram-triggered neuromuscular stimulation (EMG-stim). Random assignments were made to place the twenty chronic stroke patients in the intervention (n = 10) or control (n = 10) groups. For four weeks, the intervention group performed TOT with EMG-stim on the afflicted arm’s wrist and finger extensor for 30 minutes every day, five days a week. For the same amount of time, the control group received EMG-stim for 20 minutes per day. Muscle activation, motor recovery (measured by the Fugl-Meyer evaluation), and dexterity (measured by the Box and Block Test) all showed substantial improvements in the intervention group when compared to the control group (p < 0.05). Significant variations in the groups’ hand functions


HYPOTHESIS:

NULL HYPOTHESIS:

There is no significant difference between electrical muscle stimulation and task oriented training in improving hand function in stroke patient.

ALTERNATIVE HYPOYHESIS:

There is significant difference between electrical muscle stimulation along with task oriented training in improving hand function in stroke patient.

METHODOLOGY:  

STUDY SETTING: In patient department of medicine and  Out patient department of neuro physiotherapy at Dr APJAK College of physiotherapy

 DURATION OF STUDY: 1 Year

·       METHOD OF COLLECTION OF DATA: Data will be primary collected by principal investigator.

TYPE OF DATA: Quatitative

·       STUDY DESIGN: Randomized control trial

SAMPLING METHOD: simple random sampling

SAMPLE SIZE: 32

 SOURCE OF DATA: Dr. Vitthalrao Vikhe Patil Rural Hospital ,Pravara Institute of medial sciences loni

·       MATERIALS:

1.     Consent form

2.     Assessment sheet

3.     Box and block test

4.     Wolf motor function test(material kit)

SELECTION CRITERIA:

Inclusion criteria: 

Participation included will be

1)Patients who are admitted to pravara rural  hospital

2)Age -18-60 years

3)Patients who are willingly participate

4)Patients who are hemodynamically stable.

5)patients who are MCA stroke

 

Exclusion criteria:

1)Patients with perceptual and cognitive deficits

2)Patients with recent surgery of upper limb

4)Patient with other neurological problem

5)Patient with recurrence history of stroke

OUTCOME MEASURES:

•       1)Box and block test (reliability- 0.89 to 0.970)

•       2)Wolf motor function test (reliability- 0.95 to 0.99)

PROCEDURE:

The procedure of data collection involves the several steps, firstly the study design is decided, the sample is drawn, where the inclusion and exclusion criteria are applied from which the subjects are derived. An informed Consent is taken from every subject before participation in the complete study.

Box and block  manual dexterity was 60 functional task that determine ability to reach for and grasp a small block of wood (2.54cm cube) Lift the block or short barrier in the center of the box release the block on the other side and return to the original side repeating the process number of blocks move in the number of blocks moved in the current study represent the data from the impaired upper limb only.

wolf motor function test: A 12-month change in the log-transformed Wolf Motor Function Test time score WMFT, which is based on an average of 15 timed arm movements and hand dexterity tasks was the main outcome. The proportion of patients improving by at least 25 points on the Stroke Impact Scale (SIS) hand function score (MCID = 17.8 points) and the improvement in the WMFT time score (minimum clinically significant difference [MCID] = 19 seconds) were the secondary outcomes.  

FLOW DIAGRAM:

                        

 

Baseline assessment

Outcome measures- Berg Balance Scale, Performance Oriented Mobility Scale  

 

 

INTERVENTION:

GROUP A: (task oriented exercises with electrical muscle stimulation)

 

Duration of protocol

 

5days/ week

For 6 weeks

Faradic Electrical stimulation

10 to 15 repetitions

Duration 30 minutes.

Frequency-40hz

Pulse width-200 µs

Sr no.

Task oriented exercises

1

Grasping a glass (cylindrical)and instructed to lift up glass from the start position ,reach forward then place down at the full arm length position

2

Grasping a bottle(cylindrical) and instructed to lift up bottle from the start position, reach forward then place down at the full arm length position

3

Grasping a ball(cricket,spherical ball),(7.5cm diameter) and touching a target line

4

Grasping a block (5 cm cube ) and touching a target line

5

Grasping a bowl 27cm diameter, weight 300gm and touching target line

6

Placing coins in box

7

Lifting a 3lb basket and placing it on a table

8

Moving pipes in target line (2 Different size)

9

Using pincer grasp turns key 180 degrees left and right

GROUP B: (Task oriented training exercise)

·       Grasping a glass (cylindrical)and instructed to lift up glass from the start position ,reach forward then place down at the full arm length position

·       Grasping a bottle(cylindrical) and instructed to lift up bottle from the start position, reach forward then place down at the full arm length position

·       Grasping a ball(cricket,spherical ball),(7.5cm diameter) and touching a target line

·       Grasping a block (5 cm cube ) and touching a target line

·       Grasping a bowl 27cm diameter, weight 300gm and touching target line

·       Placing coins in box

·       Lifting a 3lb basket and placing it on a table

·       Moving pipes in target line (2 Different size)

·       Using pincer grasp turns key 180 degrees left and right


Does the study require any interventions or investigations to be conducted on patients or other human or animals? If so, please describe briefly.

Has ethical clearance been obtained from your institution in case of 6.3?

 

REFERENCES:

1.     Timmermans AA, Spooren AI, Kingma H, Seelen HA. Influence of task-oriented training content on skilled arm-hand performance in stroke: a systematic review. Neurorehabil Neural Repair. 2010 Nov-Dec;24(9):858-70. doi: 10.1177/1545968310368963. Epub 2010 Oct 4. PMID: 20921325.

2.     Israely S, Leisman G, Carmeli E. Improvement in arm and hand function after a stroke with task-oriented training. BMJ Case Rep. 2017 Mar 17;2017:bcr2017219250. doi: 10.1136/bcr-2017-219250. PMID: 28314812; PMCID: PMC5372193.

3.     Israely S, Leisman G, Carmeli E. Improvement in arm and hand function after a stroke with task-oriented training. BMJ Case Rep. 2017 Mar 17;2017:bcr2017219250. doi: 10.1136/bcr-2017-219250. PMID: 28314812; PMCID: PMC5372193

4.     Page SJ, Maslyn S, Hermann VH, Wu A, Dunning K, Levine PG. Activity-based electrical stimulation training in a stroke patient with minimal movement in the paretic upper extremity. Neurorehabil Neural Repair. 2009 Jul-Aug;23(6):595-9. doi: 10.1177/1545968308329922. Epub 2008 Dec 17. PMID: 19095624.

5.     Lubetzky-Vilnai, Anat PT, MSc; Kartin, Deborah PT, PhD. The Effect of Balance Training on Balance Performance in Individuals Poststroke: A Systematic Review. Journal of Neurologic Physical Therapy 34(3):p 127-137, September 2010. | DOI: 10.1097/NPT.0b013e3181ef764d

6.     Kim SH, Park JH, Jung MY, Yoo EY. Effects of Task-Oriented Training as an Added Treatment to Electromyogram-Triggered Neuromuscular Stimulation on Upper Extremity Function in Chronic Stroke Patients. Occup Ther Int. 2016 Jun;23(2):165-74. doi: 10.1002/oti.1421. Epub 2016 Feb 15. PMID: 26876527.

7.     The Effect of Bilateral Upper Limb Training on Recovery of Upper Limb Function in Patients with Acute Stroke Sang-Hwa Lee1 , Bo-Kyoung Song2 , Ha-Na Kim

8.     The influence of Task-Related Training combined with Transcutaneous Electrical Nerve Stimulation on paretic upper limb muscle activation in patients with chronic stroke

 

 

 
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