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CTRI Number  CTRI/2023/10/059188 [Registered on: 27/10/2023] Trial Registered Prospectively
Last Modified On: 25/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   effect of electrical stimulation on one of the shoulder muscle in people with stroke 
Scientific Title of Study   Immediate effects of electrical stimulation on serratus anterior muscle activity in people with stroke 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Palak Kakwani 
Designation  Post Graduate student 
Affiliation  Ramaiah College of Physiotherapy 
Address  Ramaiah College of Physiotherapy, Ramaiah University of Applied Sciences, MS Ramaiah Nagar, MSRIT Post, Bangalore-560054
Ramaiah College of Physiotherapy, Ramaiah University of Applied Sciences, MS Ramaiah Nagar, MSRIT Post, Bangalore-560054
Bangalore
KARNATAKA
560054
India 
Phone  9879015297  
Fax    
Email  palakkakwani@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Ramesh Debur 
Designation  Associate Professor  
Affiliation  Ramaiah College of Physiotherapy 
Address  Ramaiah College of Physiotherapy, Ramaiah University of Applied Sciences, MS Ramaiah Nagar, MSRIT Post, Bangalore-560054

Bangalore
KARNATAKA
560054
India 
Phone  9845544848  
Fax    
Email  rameshdebur@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mr Ramesh Debur 
Designation  Associate Professor  
Affiliation  Ramaiah College of Physiotherapy 
Address  Ramaiah College of Physiotherapy, Ramaiah University of Applied Sciences, MS Ramaiah Nagar, MSRIT Post, Bangalore-560054

Bangalore
KARNATAKA
560054
India 
Phone  9845544848  
Fax    
Email  rameshdebur@gmail.com  
 
Source of Monetary or Material Support  
MS Ramaiah Hospitals New Bel Rd, MS Ramaiah Nagar, MSRIT Post, Bengaluru Karnataka- 560054  
 
Primary Sponsor  
Name  Palak Kakwani 
Address  Ramaiah College of Physiotherapy Ramaiah University of Applied Sciences MS Ramaiah Nagar, MSRIT Post, Bengaluru-560054  
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 Ramesh Debur  MS Ramaiah Hospitals   Biofeedback Lab Physiotherapy Department New Bel Rd, M S Ramaiah Nagar, MSRIT Post, Bengaluru, Karnataka- 560054
Bangalore
KARNATAKA 		 9845544848

rameshdebur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MS Ramaiah Medical College and Hospitals   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G811||Spastic hemiplegia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Electrical Muscle Stimulation  Serratus Anterior muscle of the paretic side will be electrically stimulated using 2 pole electrodes frequency- 50Hz pulse width- 0.2 ms intensity- as tolerated by patient time duration- 20 minutes 
Comparator Agent  N/A  N/A 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. People with subacute and chronic Stroke.
2. People with Stroke of age 18 and above.
3. People with stroke able to sit independently.
4. Brunnstorm’s recovery stage- grade 3 and above.
 
 
ExclusionCriteria 
Details  1. People with Stroke having cognitive deficits
2. People with Stroke having sensory deficits
3. People with Stroke unable to sit independently
4. Modified Ashworth Scale (MAS) score 3 and above
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Surface Electromyography
 		 pre and post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
component of Fugl-Meyer Assessment of upper extremity  pre and post intervention 
 
Target Sample Size   Total Sample Size="19"
Sample Size from India="19" 
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)   10/11/2023 
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 the sudden loss of neurological function caused by an interruption of blood flow to the brain.Upper limb impairment occurs in approximately 80% of stroke survivors.The scapula plays a central role in normal shoulder kinematics. Scapula on the thorax contributes to elevation of the arm by rotating the glenoid fossa upward.This motion is produced by a balanced force couple between trapezius and serratus anterior. Serratus anterior, because of its long moment arm generates more torque and has a dominant role in the force couple. Serratus anterior weakness can alter the scapular orientation and stability leading to pathological kinematics.Very few studies have focused on serratus anterior while training for upper extremity rehabilitation. Hence there is a need to focus on serratus anterior activity during upper extremity training in stroke population. Among many interventions, Electrical stimulation is proven to be useful for motor recovery post stroke.

 
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