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CTRI Number  CTRI/2024/07/070290 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 08/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   To assess the better combo-therapy (Electrical Stimulation with Kinesiology Tape versus Kinesiology Tape with Rehabilitative Exercises) in post stroke cases in treating the oral phase of acute dysphagia. 
Scientific Title of Study   A Comparative Study Between Electrical Stimulation With Kinesiology Tape Versus Kinesiology Tape with Rehabilitative Exercises To Improve Swallowing In Oral Phase of Acute Dysphagia In Post Stroke Cases 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sonam Sharma 
Designation  Post Graduate Student 
Affiliation  Shri Guru Ram Rai University School of Paramedical and Allied Health sciences 
Address  Shri Mahant Indresh hospital Department of Physiotherapy North Block, Basement Dehradun UTTRANCHAL 248001 India

Dehradun
UTTARANCHAL
248001
India 
Phone  6396934698  
Fax    
Email  sonam54355@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Kumar 
Designation  Assistant Professor  
Affiliation  Shri Guru Ram Rai University School of Paramedical and Allied Health sciences 
Address  Shri Mahant Indresh hospital Department of Physiotherapy North Block, Basement Dehradun UTTRANCHAL 248001 India

Dehradun
UTTARANCHAL
248001
India 
Phone  9412468744  
Fax    
Email  drskumarmalik@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sonam Sharma 
Designation  Post Graduate Student 
Affiliation  Shri Guru Ram Rai University School of Paramedical and Allied Health sciences 
Address  Shri Mahant Indresh hospital Department of Physiotherapy North Block, Basement Dehradun UTTRANCHAL 248001 India

Dehradun
UTTARANCHAL
248001
India 
Phone  6396934698  
Fax    
Email  sonam54355@gmail.com  
 
Source of Monetary or Material Support  
Shri Guru Ram Rai University, school of Paramedical and Allied Health Sciences,Pathribagh,Dehrdun, Uttrakhand, 248001 
 
Primary Sponsor  
Name  Sonam Sharma 
Address  Shri Guru Ram Rai University, school of Paramedical and Allied Health Sciences,Pathribagh,Dehrdun, Uttrakhand, 248001 
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 Sonam Sharma PT  Shri Mahant Indresh Hospital , Dehadun  Shri Mahant Indresh Hospital Department of Physiotherapy North Block Division, Basement Dehradun UTTRANCHAL 248001 India Dehradun
Dehradun
UTTARANCHAL 		 6396934698

sonam54355@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(IEC) SHRI GURU RAM RAI INSTITUTE OF MEDICAL AND HEALTH SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I698||Sequelae of other cerebrovasculardiseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Kinesiology Tape(KT) with Rehabilitative exercises in treating the oral phase of acute dysphagia in Post stroke cases.  Application of Kinesio Tape will be the same as above. The comprehensive Rehabilitative exercises program involves patients sitting on chairs or couches in front of a mirror and using a tongue depressor for resistance exercises, with regular rests and mouth moisturization as needed. The program includes four core exercises to be followed every week : effortful swallowing, Shaker’s exercise, jaw thrusts, and the Masaka maneuver, performed consistently across all sessions. Over six weeks, patients follow a progressively challenging regimen. In weeks 1 and 2, they perform lip, jaw, and tongue exercises focusing on movement and resistance . In weeks 3 and 4, they hold these positions for 30 seconds . In weeks 5 and 6, they perform rapid repetitions for 60 seconds hold . The exercises aim to improve swallowing function and muscle strength through varied movements and sustained holds. This treatment is given on the alternate days in a week and duration for treatment is 30-35 mins per session. Intervention is given for 6 weeks. 
Intervention  Transcutaneous Electrical Nerve Stimulation (TENS) with Kinesiology Tape in treating the oral phase of acute dysphagia in Post stroke cases.   TENS is a modality whose electrode will be placed on Muscles of mastication (Masseter muscle, Buccinator). Patient will be in a supine position. Parameters of TENS will be 80–100 Hz for pulse duration of 300 micros and current from 1–14 mA , intensity will be accord tolerance of the patient for 15 mins.The patient will be asked to repeatedly dry swallow their saliva. With progress, in condition the patient is upgraded to swallow thick semi solid foods during the protocol. For this patient in Sitting position ,To treat masseter muscle, open the jaw, stretch the lower jaw, and measure the distance between the zygomatic arch and mandible. Cut a Kinesiology Tape 2 cm shorter than the muscle measurement and shape it into a V shape. Apply 70% stretch to two strips of tape, smooth them onto the skin, and rub them to ensure adhesion. To stretch the buccinator muscle, cut an I-shaped tape, fill air in cheek, place anchor below temporomandibular joint, stretch 70%, attach near lip angle, and ensure adhesion. This treatment is given on the alternate days in a week and duration for treatment is 30-35 mins per session. Intervention is given for 6 weeks. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  Patients of the above age group 30 years.
Conscious and responsive enough to answer the instrument.
Patients with acute dysphagia less than 1 month.
GCS score of 11-15.

 
 
ExclusionCriteria 
Details  Unconscious patients.
Patients with sensory impairments.
Pregnancy, head and neck cancer patients.
Patients with an implanted pacemaker and any other metal implant in the body.
Patients with severe pulmonary dysfunction, dementia, aphasia.
Patients who had severe aspirations and who were completely unable to swallow anything.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Functional Oral Intake Scale (FOIS)  1st day and end of 6th week  
 
Secondary Outcome  
Outcome  TimePoints 
Guggling Swallowing screen Scale (GUSS)  1st day and end of 6th week  
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   22/07/2024 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Swallowing is a highly coordinated, multifaceted, and neuromuscularly connected process. The process is divided into three phases based on the bolus location: oral, pharyngeal, and esophageal . The Masseter, Temporalis, medial and lateral pterygoid, buccinator and orbicularis oris, are facial muscles that are important for oral swallowing . Dysfunction in these muscles might result from their weakness. so it is important to treat oral phase of acute dysphagia.  The purpose of dysphagia rehabilitation is to identify and treat the underlying causes of swallowing issues, enhance swallowing function, and ensure safe and efficient feeding and hydration. To provide comprehensive care for patients with dysphagia, healthcare experts from several disciplines, including physicians, dietitians, and speech therapists, collaborate in a multidisciplinary manner.
 
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