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CTRI Number  CTRI/2023/01/049217 [Registered on: 25/01/2023] Trial Registered Prospectively
Last Modified On: 26/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect Of Kinesthetic Illusion Induced By Visual Stimulation On Hand Functions In Stroke Patients  
Scientific Title of Study   Effect Of Kinesthetic Illusion Induced By Visual Stimulation On Hand Function In Patients With Chronic Stroke: A Pilot Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vanu Bharwani 
Designation  Post graduate Student 
Affiliation  MGM Institute of Physiotherapy, Aurangabad 
Address  Department of Neuro Physiotherapy OPD no. 5, MGM Institute of Physiotherapy, N-6 Cidco Aurangabad, Maharashtra

Aurangabad
MAHARASHTRA
431003
India 
Phone  9146366727  
Fax    
Email  vanu.bharwani123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashwini Rodge 
Designation  Professor 
Affiliation  MGM Institute of Physiotherapy, Aurangabad 
Address  Department of Neuro Physiotherapy OPD no. 5, MGM Institute of Physiotherapy, N-6 Cidco Aurangabad, Maharashtra

Aurangabad
MAHARASHTRA
431003
India 
Phone  7263891882  
Fax    
Email  ashwinikalept@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Vanu Bharwani 
Designation  Post graduate Student 
Affiliation  MGM Institute of Physiotherapy 
Address  Department of Neuro Physiotherapy OPD no. 5, MGM Institute of Physiotherapy, N-6 Cidco Aurangabad, Maharashtra

Aurangabad
MAHARASHTRA
431003
India 
Phone  9146366727  
Fax    
Email  vanu.bharwani123@gmail.com  
 
Source of Monetary or Material Support  
MGM Institute of Physiotherapy, Aurangabad 
 
Primary Sponsor  
Name  MGM Institute of Physiotherapy, Aurangabad 
Address  N-6, Cidco, Aurangabad-431003, Maharashtra 
Type of Sponsor  Private medical college 
 
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 
Vanu Bharwani  MGM Medical College   Department of Neuro Physiotherapy OPD No-5,MGM Institute of Physiotherapy, N-6 Cidco, Aurangabad 431003
Aurangabad
MAHARASHTRA 		 9146366727

vanu.bharwani123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGM Institute of Physiotherapy-Institutional Ethical Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G968||Other specified disorders of central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Arm 1- Kinesthetic Illusion Induced By Visual Stimulation  Patients will be seated in a comfortable position with their forearm resting on the top of the table. A pre-recorded video of hand movement of unaffected side will be flipped horizontally and projected on a monitor, which will be placed over the affected forearm to provide the illusion that the patient’s forearm is identical to that depicted in the video. Duration of treatment 20 minutes (2 sets of 10 minutes) Frequency of treatment 5 Days/week for 4 weeks The video will show that the hand repeatedly grasps an object for 3 seconds and releases the object for 3 seconds, with a total of 20 min (2 sessions of 10 minutes).  
Comparator Agent  Arm 2- Conventional Physiotherapy  Conventional physiotherapy includes normalize movement patterns and minimize spasticity. Physical therapy included static and dynamic control of position, balance skills, weight shifts, and activities of daily living 5 days/week for the duration of 4 weeks 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1- Patients with chronic stroke
2- Patients with Brunnstorm hand recovery score more than or equal to 3
3- Mini Mental scale score more than 24
 
 
ExclusionCriteria 
Details  1- Patients with severe communication difficulty.
2- Severe perceptual and visual disorders
3- Patients with other neurological conditions.
4- Patients with upper limb musculoskeletal injuries and upper limb fractures.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1- Fugl Meyer Assessment- Upper Extremity
2- Modified Ashworth Scale
3- Box and Block Test 		 Baseline and at 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/01/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
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   Upper limb motor dysfunction is a common and undesirable consequence of stroke that increases activity limitation and reduces their quality of life (QOL). Hand function impairment in chronic stroke is related to decreased ability to control voluntary muscle activity and the abnormal recruitment of contralateral corticoreticulospinal pathways. Kinesthetic illusion induced by visual stimulation (KINVIS) is an implicit motor imagery that is carried as a result of cognitive substitution of the paralyzed real body with a functioning virtual body. Kinesthetic illusion induced by visual stimulation (KINVIS) has been demonstrated to induce a vivid kinesthetic sensation without accompanying voluntary movement. The aim of this study is to evaluate effect of kinesthetic illusion induced by visual stimulation (KINVIS) on hand function in patients with chronic stroke. Patients with stroke of age between 45 years to 65 years will be included in the study. Patients will be screened according to the inclusion and exclusion criteria. Before the collection of the data informed written consent will be obtained.  The patients will be allocated into two exercise groups using a block randomization method. The participants in interventional group will be receiving Kinesthetic illusion induced by visual stimulation (KINVIS) and conventional therapy. Patients will be seated in a comfortable position with their forearm resting on the top of the table. A pre-recorded video of hand movement of unaffected side will be flipped horizontally and projected on a monitor, which will be placed over the affected forearm to provide the illusion that the patient’s forearm is identical to that depicted in the video. The video will show that the hand repeatedly grasps an object for 3 seconds and releases the object for 3 seconds, with a total of 20 min (2 sessions of 10 minutes). Conventional therapy group aimed to normalize movement patterns and minimize spasticity. Physical therapy included static and dynamic control of position, balance skills, weight shifts, and activities of daily living. The pre-treatment data will be obtained using Fugl meyer assessment scale-upper extremity, Modified ashworth scale and Block and block test. The intervention will be given to the patients of both the groups for 4 weeks. After completion of the intervention, the patients will be screened for post treatment data.  
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