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CTRI Number  CTRI/2024/05/067301 [Registered on: 14/05/2024] Trial Registered Prospectively
Last Modified On: 21/01/2025
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   Improving Breathing in Stroke Survivors: The Impact of Electrical Muscle Stimulation on Abdominal and Respiratory Muscles  
Scientific Title of Study   Effect of neuromuscular electrical stimulation on rectus abdominus and transverse abdominus on the respiratory parameters in stroke survivors- a randomized controlled 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  Adriana Maria Dsouza 
Designation  Postgraduate student  
Affiliation  Nitte Institute of Physiotherapy, Nitte( Deemed to be University) 
Address  Department of Physiotherapy, ,room no 20,Justice K.S Hegde Hospital,Deralakatte, Mangaluru Nitte Institute of Physiotherapy, NITTE Deemed to be university, Nityanand Nagar,Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  08971279902  
Fax    
Email  adrianamariadsouza67@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Jayesh Chandran 
Designation  Assistant Professor 
Affiliation  NITTE INSTITUTE OF PHYSIOTHERAPY, NITTE DEEMED TO BE UNIVERSITY 
Address  NITTE INSTITUTE OF PHYSIOTHERAPY, NITTE Deemed to be university, Nityanada Nagar,Deralakatte, Mangaluru Department 20, Department of Physiotherapy, Justice K.S Hegde Hospital,Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9383443710  
Fax    
Email  jayesh.nairpt@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Mr Jayesh Chandran 
Designation  Assistant Professor 
Affiliation  Nitte Institute of Physiotherapy, Nitte (Deemed to be University) 
Address  Nitte Institute of Physiotherapy, Nitte Deemed to be University, Nityanada Nagar,Deralakatte, Mangaluru Department 20, Department of Physiotherapy, Justice K.S Hegde Hospital,Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9383443710  
Fax    
Email  jayesh.nairpt@nitte.edu.in  
 
Source of Monetary or Material Support  
Department of Physiotherapy Room no 20, second base division, Nitte institute of physiotherapy, Nitte (Deemed to be university)Derlakatte, Mangaluru 575018, Karnataka, India: will provide basic infrastructure facilities. No other monitory support is required. 
 
Primary Sponsor  
Name  NITTE Institute of physiotherapy, NITTE (Deemed to be university) 
Address  NITTE institute of physiotherapy, NITTE Deemed to be university, Nityanadanagar, Deralakatte, Mangaluru-575018,DK, Karnataka 
Type of Sponsor  Research institution and hospital 
 
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 
Adriana Maria Dsouza  Justice K.S Hegde Charitable Hospital  Department no 10, department of Medicine, Medical science complex, Deralakatte, Mangaluru- 575018
Dakshina Kannada
KARNATAKA 		 8971279902

adrianamariadsouza67@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Nitte Institute of Physiotherapy, Nitte (Deemed ti0 be university)  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  Conventional physiotherapy management of stroke  Positioning, early mobilization ( which includes bed mobility, edge of bed sitting as tolerated by the patient), contracture management which includes stretching of tight muscles e.g. tibialis anterior, balance training) starting with sitting balance training), standing training (initially with the support of walker progress to standing without support), gait and mobility training All of the above mentioned training will be done as tolerated by the patient, for 35-45 mins for 5 days 
Intervention  Neuro-muscular electrical stimulator  Dosage of the neuro muscular electrical stimulation: frequency of 50Hz , pulse duration of 300 microseconds, rise time of 1 second; stimulus time of 3 seconds, and relaxation time of 10 seconds. Gradual increase in the intensity until significant muscle contraction occurs. Stimulation will be given for 20 minutes for 5 days. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Consent of the patient to participate in the study is required.
Participants should be aged between 40 and 75 years, inclusive of both men and women, with a clinical diagnosis of stroke.
The patient must be hemodynamically stable on the day of examination and intervention.
The duration of stroke from onset should be up to 6 months. 
 
ExclusionCriteria 
Details  Patients with a history of seizures, individuals who have undergone thoracic or abdominal surgery in the past year, and those experiencing respiratory tract infections should be noted. Additionally, consideration should be given to patients with chronic respiratory diseases affecting respiratory muscle function (such as bronchial asthma or COPD), individuals with grade 4 and 5 strength of abdominal muscles, and patients with pacemakers. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Spirometry, palpation meter (PALM) device, chest expansion, Barthel Index  outcomes will be assessed at baseline and after 1 week of intervention  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/07/2024 
Date of Study Completion (India) 06/02/2025 
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)   Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 WHO defines stroke as rapidly developed clinical signs of focal(or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than vascular origin. Stroke has various symptoms including muscular and cognitive domines, one of the most overlooked symptom is the respiratory complications. The aim of the study is to identify the effectiveness of neuromuscular electrical stimulator on the respiratory and abdominal muscles and its effects on the respiratory parameters. Selected participants will be randomly allocated into control group and experimental group. The control group will be receiving conventional physiotherapy established for stroke management and the experimental group will receive the conventional physiotherapy along with neuro-muscular electrical stimulation, electrical stimulation will be given for 5 days with the frequency of 50 Hz, pulse duration of 300 microseconds. the outcome measures which will be used are spirometry, chest expansion using inch tape, PALM meter and Barthel index, these outcomes will be assessed pre and post intervention. The data collected will be assessed and analysed.  
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