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CTRI Number  CTRI/2025/06/088325 [Registered on: 05/06/2025] Trial Registered Prospectively
Last Modified On: 03/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the immediate effect of imagining bilateral arm and hand movements followed by its intensive training on bilateral arm and hand activities to improve bilateral arm and hand function in individuals with stroke 
Scientific Title of Study   IMMEDIATE EFFECT OF MOTOR IMAGERY MI ALONG WITH HAND ARM BIMANUAL INTENSIVE TRAINING HABIT ON UPPER EXTREMITY FUNCTION IN SUBJECTS WITH STROKE A RANDOMIZED CLINICAL 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  Dr Lakshmiprabha Rangarajan 
Designation  Professor (Addl) 
Affiliation  P. T. School and Centre Seth GSMC and KEMH 
Address  P.T. School and Centre Seth GSMC and KEMH 402 Physiotherapy department, Room number 3, OC Building, E Borges road, opp to TATA Hospital, Parel Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9870487879  
Fax    
Email  laps2204@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Lakshmiprabha Rangarajan 
Designation  Professor (Addl) 
Affiliation  P. T. School and Centre Seth GSMC and KEMH 
Address  P.T. School and Centre Seth GSMC and KEMH 402 Physiotherapy department, Room number 3, OC Building, E Borges road, opp to TATA Hospital, Parel Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9870487879  
Fax    
Email  laps2204@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mansvi Gawande 
Designation  Post graduate Neurophysiotherapy student 
Affiliation  P. T. School and Centre Seth GSMC and KEMH 
Address  P.T. School and Centre Seth GSMC and KEMH 402 Physiotherapy department, Room number 3, OC Building, E Borges road, opp to TATA Hospital, Parel Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  8237905008  
Fax    
Email  gawandemansvi@gmail.com  
 
Source of Monetary or Material Support  
P. T. School and Centre Seth GSMC and KEMH 402 Physiotherapy department, Room number 3, OC Bldg, E Borges road, opp to TATA Hospital, Parel Mumbai MAHARASHTRA 400012 India 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 
Dr Lakshmiprabha Rangarajan  P. T. School and Centre, Seth GS Medical College and KEM Hospital  P.T. School and Centre Seth GSMC and KEMH 402 Physiotherapy department, Room number 3, OC Building, Ernest Borges road, opp to TATA Hospital, Parel Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA 
09870487879

laps2204@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee 3 of Seth GSMC and KEMH   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I699||Sequelae of unspecified cerebrovascular diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hand Arm Bimanual Intensive Training (HABIT)  In this type of intervention, the subject will be made to sit on a chair in front of the table.The unaffected upperlimb and affected upperlimb will be placed on the table.They will be performing a set of Symmetrical and Asymmetrical activities in HABIT.Instruction to physically practice each activity will be given to the subject.Then they will be made to perform the same set of activities. 2 minutes rest period will be given in between each activity.This intervention is administered for one time as we are assessing immediate effect. 
Intervention  Motor Imagery(MI) along with Hand Arm Bimanual Intensive Training (HABIT)  In this type of intervention, the subject will be made to sit on a chair in front of the table containing task-related materials like video displayed on the laptop screen, bottle, paper ,container, etc . The unaffected upperlimb and affected upperlimb will be placed on the table. The subject will be first asked to observe the video of motor tasks .Then , subject will be asked to mentally practice each activity.They will be performing a set of Symmetrical and Asymmetrical activities in HABIT. Instruction to physically practice each activity will be given to the subject.Then they will be made to perform the same set of activities. 2 minutes rest period will be given in between each activity. This intervention is administered for one time as we are assessing immediate effect.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Bruunstorm hand functions grades from 2 to 5, Subjects diagnosed with subacute [ 3 months to 6 months] and chronic [6 months or more] unilateral stroke patients ,
Participants were included if they scored more than 25 on the MIQ
 
 
ExclusionCriteria 
Details  Any acute cardiovascular, respiratory and musculoskeletal impairment,Uncontrolled Diabetes and Hypertension,Uncorrected Visual and Auditory impairments, Any other neurological impairments other than Stroke, Any Psychiatric illness 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Chedoke Arm and Hand Action Inventory scale-7(CAHAI-7)
Action Research Arm Test(ARAT)
Fugl-Meyer Assessment-upper extremity Scale
 
1 Year 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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)   14/06/2025 
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)   Open to Recruitment 
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  

Stroke is sudden loss of neurological functions caused by impaired perfusion of brain. Absence of ankle control is one of the most prevalent and challenging problem in rehabilitation following stroke . In some patients there is serious loss of strength in affected limb which makes it difficult to carryout exercises in paralytic limb and it also demotivates the patient. Patients with stroke have difficulty in sit to stand activity, standing, walking and weight bearing on affected limb as a result of pain, spasticity, muscle weakness, sensory problems and affected balance. Mirror therapy is a type of intervention in which mirror is placed in midsagittal plane to create a reflection of non affected limb to create an illusion as affected limb is moving normally. It helps to create an illusion as if affected limb is moving and thereby creating a beneficial effects. Studies have been done which explains the beneficial effect in affected limb if resistance training of unaffected limb is done. So the purpose of this study is to find whether the resisted ankle dorsiflexor exercises augment the effect of mirror therapy in motor recovery of stroke patients or not. Also to check whether there is any immediate effect of combination of mirror therapy and resisted ankle exercises on motor outcomes and functional mobility in post stroke patients. There is a need to check whether the participant feels that the movement is happening in affected limb or not during the session. Therefore there is also a need to assess the generation of the sense of agency during the session. To carry the reseach work prior permission of Institutional Ethics Committee will be taken. Subjects will be randomly assigned into two groups using computerized randomisation chart, Group A and Group B. Group A will undergo mirror therapy with resisted ankle dorsiflexor exercises and Group B will undergo mirror therapy alone. Pre intervention assessment of both the groups will be done which includes- Active and passive range of motion using standardized universal goniometer, Modified Tardieu Scale, Timed up and go test, walking velocity using 10 meter walk test. Additionally measurement sense of agency will be evaluated using visual analogue scale of both the group. If the data is normally distributed then parametric tests like paired and unpaired t-tests will  be used and if the data is not normally distributed then non parametric tests like Mann-Whitney U test and Wilcoxon signed-rank test will be used for intra and inter group analysis.

 
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