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CTRI Number  CTRI/2025/05/087288 [Registered on: 21/05/2025] Trial Registered Prospectively
Last Modified On: 16/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Testing the effect of Special Muscle Feedback Exercise vs Regular Exercise for Better Hand and Wrist Recovery in Subjects with Paralysis.  
Scientific Title of Study   A Study to compare Additive Effect of Electromyographic Biofeedback vs Conventional Treatment on Spasticity and Upper Limb Motor Function in Subacute Stroke Subjects with Wrist and Hand Dysfunction – A Comparative Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
vishwa2712  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vishwa Bengali 
Designation  PG Scholar 
Affiliation  PG Scholar, Marwadi University 
Address  MB557, Faculty of Physiotherapy, Marwadi University, Rajkot Morbi Highway, Rajkot.

Rajkot
GUJARAT
360003
India 
Phone  9427439816  
Fax    
Email  vishwa.bengali123805@marwadiuniversity.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Vishwa Bengali 
Designation  PG Scholar 
Affiliation  Marwadi University 
Address  MB557, Faculty of Physiotherapy, Marwadi University, Rajkot Morbi Highway, Rajkot.

Rajkot
GUJARAT
360003
India 
Phone  9427439816  
Fax    
Email  vishwa.bengali123805@marwadiuniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  Vishwa Bengali 
Designation  PG Scholar 
Affiliation  Marwadi University 
Address  Faculty of Physiotherapy, Marwadi University, Rajkot Morbi Highway, Rajkot.

Rajkot
GUJARAT
360003
India 
Phone  9427439816  
Fax    
Email  vishwa.bengali123805@marwadiuniversity.ac.in  
 
Source of Monetary or Material Support  
MCS001, Marwadi Campus OPD, Faculty Of Physiotherapy, Marwadi University, Rajkot Morbi Highway, Rajkot 360003 
 
Primary Sponsor  
Name  Vishwa Bengali 
Address  MB557, Faculty of Physiotherapy, Marwadi University, Rajkot Morbi Highway, Rajkot 360003 
Type of Sponsor  Other [Self] 
 
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 Ashish Kakkad  Physiotherapy OPD, Marwadi University  MCS001, Faculty of Physiotherapy, Marwadi University, Rajkot Morbi Highway, Rajkot 360003
Rajkot
GUJARAT 		 9824415797

ashish.kakkad@marwadieducation.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Marwadi University Ethical Committee  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 
Comparator Agent  Electromyographic biofeedback and Conventional Treatment  In Electromyographic Biofeedback , with the help of Pheezee device patient will perform exercise whereas in conventional treatment patient will be given treatment in the form of long flexor stretching, icing and passive movement of affected limb 
Intervention  Electromyographic Biofeedback, Sustained Stretching and Passive Movements  In this study, the control group will be given conventional treatment in the form of sustained stretching and passive movement of the affected upper limb. Whereas, in the experimental group, along with conventional treatment that is sustained stretching and passive movement, electromyographic biofeedback will be given in order to see the additive effect on spasticity and upper limb motor function. After 4 weeks of intervention, the result obtained from both groups will be compared and conclusion will be given. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subjects with 3 to 6 months post-stroke duration.
Mini mental status examination score should be less than 24
Skin intact on hemiparetic arm
Medically stable  
 
ExclusionCriteria 
Details  Modified Ashworth Scale (MAS) less than or equal to 3.
Other acute injuries to arms or hands.
Intramuscular Botox injections in any upper extremity muscle in the last 3 months.
Subjects with cardiac pacemakers.
Stroke patients who are not cooperative.
Stroke patients who have auditory and/or visual deficits.
Stroke patients who do not have proper medical history .
Subjects having another neurological deficit with stroke. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is Spasticity and upper limb motor function, which will be assessed pre-test and post-test.  OUtcomes will be measured at baseline data and after 4 weeks of intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   01/07/2025 
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)   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   Stroke is a sudden loss of neurological functions. It can be either an ischemic or hemorrhagic type of stroke. The subjects suffering from stroke have various motor symptoms, out of which spasticity is one of the most common features found in the affected limb. Subjects with stroke have various treatment procedures available to deal with these problems, such as early medical interventions and rehabilitation programs and a wide range of techniques, and these approaches are used currently in rehabilitation programs. These techniques have partial effectiveness, especially for upper extremities and hand, as key role player in activities of daily living (ADL) performances. Due to the progressive increase in stroke incidence and the need for effective therapy, the effectiveness of biofeedback therapy on the hand function and activities of daily living performances in stroke survivors should be studied.  
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