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CTRI Number  CTRI/2021/07/034905 [Registered on: 15/07/2021] Trial Registered Prospectively
Last Modified On: 22/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Activation of Muscle using Normal and Inverted Mirror Feedback in people with Stroke 
Scientific Title of Study   Muscle Activation of Hemiparetic Upper Limb using Mirror and Flipped Mirror-Image Feedback in Stroke Survivors 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ishaa A Mahale 
Designation  Postgraduate student 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone  9869734310  
Fax    
Email  mahale.alhad@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Manikandan N 
Designation  Associate Professor Senior Scale 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone  9886898064  
Fax    
Email  mani.kandan@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Senthil Kumaran D 
Designation  Associate Professor  
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone  9986910303  
Fax    
Email  senthil.kumaran@manipal.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 
 
Primary Sponsor  
Name  Manipal College of Health Professions Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ishaa Mahale  Kasturba Hospital Manipal  Department of Physiotherapy Kasturba Hospital Madhav Nagar Tiger Circle Manipal 576104
Udupi
KARNATAKA 		 9869734310

mahale.alhad@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I63||Cerebral infarction, (2) ICD-10 Condition: I630||Cerebral infarction due to thrombosis of precerebral arteries, (3) ICD-10 Condition: I631||Cerebral infarction due to embolism of precerebral arteries, (4) ICD-10 Condition: I632||Cerebral infarction due to unspecified occlusion or stenosis of precerebral arteries, (5) ICD-10 Condition: I633||Cerebral infarction due to thrombosis of cerebral arteries, (6) ICD-10 Condition: I634||Cerebral infarction due to embolism of cerebral arteries, (7) ICD-10 Condition: I635||Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries, (8) ICD-10 Condition: I636||Cerebral infarction due to cerebral venous thrombosis, nonpyogenic, (9) ICD-10 Condition: I638||Other cerebral infarction, (10) ICD-10 Condition: I639||Cerebral infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mirror-Image Feedback, Flipped Mirror-Image feedback  Activities to be performed will be simple activities of daily living that are used with mirror feedback. A total of Five activities will be selected for performing. Mirror Feedback: Participants will be explained about procedure & appropriate instructions will be provided. Patient position: Individual will be made to sit on a comfortable chair without armrest. Participant will be positioned in such a way that he/she is facing the monitor. Patient instructions: Instructions to perform the movements and use the mirror feedback looking at the screen will be provided. Flipped Mirror-image feedback: Participants will be explained about procedure & familiarized with the Flipped Mirror-image feedback. Patient position: Participant will be made to sit in a comfortable chair without armrest. Participant will be positioned in such a way that he/she is facing the monitor. Patient instructions: Instructions to perform the activities and use the feedback from screen will be provided. Duration of feedback training: Participant will be advised to perform each movement ten times, using Mirror feedback or Flipped Mirror-image feedback for 5 minutes. After each activity 5 minutes rest period will be provided. After performing all the movements, participant will be given rest period for 20 minutes before doing the next feedback training/ until the muscles relax. The tasks will be terminated if participant feels that, he/she could not continue to perform the movement for required duration. Tasks will be attempted next day for such participants if feasible. Surface EMG Recording: EMG electrodes will be placed in the selected muscles like lateral deltoid, anterior deltoid, long head of Triceps Brachii, Long head of Biceps Brachii, Pronator Teres, Extensor Carpi Radialis and Palmaris Longus, as per the SENIAM guidelines. Muscle activities during both the feedback training will be recorded from the selected muscles of hemiparetic upper limb. Root Mean Square values indicating the muscle contraction will be noted from each muscle during both the feedback training. Percentage of Maximal Voluntary Contraction will be calculated for each muscle in hemiparetic upper limb.  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Individuals with hemiparesis resulting from first onset of stroke
2. Age range of 30 to 65 years
3. Both sexes
4. Brunnstrom voluntary control stage more than 1 in hemiparetic upper limb
 
 
ExclusionCriteria 
Details  1. Musculoskeletal & other neurological disorder affecting upper limb function
2. Poor cognition with score <5 on Mini Cog scale
3. Visuo-spatial neglect
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Activation of muscles of Hemiparetic Upper Limb  1 time point 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "14"
Final Enrollment numbers achieved (India)="14" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   19/07/2021 
Date of Study Completion (India) 31/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="11"
Days="20" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Description Of Protocol

This Pilot Randomized Crossover Trial aims to study study the activation of muscles of hemiparetic upper limb during mirror feedback and flipped mirror-image feedback in stroke survivors. 
The objectives of the study are: 1. To compare the percentage Maximal Voluntary Contraction (% MVC) of selective muscles between mirror feedback and flipped mirror-image feedback 2. To compare the average time taken to perform each task between mirror feedback and flipped mirror-image feedback. 3. To compare the number of errors during task performance between mirror feedback and flipped mirror-image feedback.
 Mirror feedback therapy though commonly used in clinical practice, has the disadvantage of misinterpreting the feedback during upper extremity training in people with stroke.  Flipped mirror-image  therapy, uses the concept of providing feedback, which may be easy to interpret the sides of moving limb, hence may promote better activation on the muscles of hemiparetic upper limb. However, the role of flipped image feedback in activation of muscles compared to mirror image feedback has not been studied in hemiparetic upper limb of people with stroke.
In this study, Percentage of Maximal Voluntary Contraction (%MVC) of the selected muscles (lateral deltoid, anterior deltoid, long head of Triceps Brachii, Long head of Biceps Brachii, Pronator Teres, Extensor Carpi Radialis and Palmaris Longus) of hemiparetic upper limb across the various activities will be used to measure the activation of muscles.


 
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