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CTRI Number  CTRI/2026/01/101318 [Registered on: 16/01/2026] Trial Registered Prospectively
Last Modified On: 15/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study to Assess the effect of Expiratory Muscle Strength Training (EMST) DEVICE on Swallow Function and Aspiration prevention in patients after Tongue Cancer Surgery. 
Scientific Title of Study   Effect of Expiratory Muscle Strength Training on Dysphagia and Aspiration Prevention in Post Glossectomy Patients 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  DR Manish Verma 
Designation  Assistant Professor 
Affiliation  AIIMS , New Delhi 
Address  Department of Otorhinolaryngology and Head Neck Surgery, Room No 4058, Teaching Block , AIIMS, New Delhi
Department of Otorhinolaryngology and Head Neck Surgery, Room No 4058, Teaching Block , AIIMS, New Delhi
South
DELHI
110029
India 
Phone  9289449265  
Fax    
Email  mventhns@aiims.edu  
 
Details of Contact Person
Scientific Query
 
Name  DR Rajeev Kumar 
Designation  Professor 
Affiliation  AIIMS , New Delhi 
Address  Department of Otorhinolaryngology and Head Neck Surgery, Room No 4058, Teaching Block , AIIMS, New Delhi
Department of Otorhinolaryngology and Head Neck Surgery, Room No 4058, Teaching Block , AIIMS, New Delhi
South
DELHI
110029
India 
Phone  01126593386  
Fax    
Email  rajeev9843@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DR Manish Verma 
Designation  Assistant Professor 
Affiliation  AIIMS , New Delhi 
Address  Department of Otorhinolaryngology and Head Neck Surgery, Room No 4058, Teaching Block , AIIMS, New Delhi
Department of Otorhinolaryngology and Head Neck Surgery, Room No 4058, Teaching Block , AIIMS, New Delhi
South
DELHI
110029
India 
Phone  01126593386  
Fax    
Email  mventhns@aiims.edu  
 
Source of Monetary or Material Support  
Department of Otorhinolaryngology and Head Neck Surgery, AIIMS, New Delhi 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
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 Manish Verma  AIIMS, New Delhi  Department of Otorhinolaryngology and Head Neck Surgery, Room No 4058, Teaching Block , AIIMS, New Delhi
South
DELHI 
9289449265

mventhns@aiims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE, AIIMS NEW DELHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  EMST DEVICE  EMST focuses on strengthening mechanisms of airway protection and defence. EMST has been shown to increase expiratory pressure generation by 30% to 150%, with an average of 50% in a 4-week period of time by improving closure for swallowing by exercise of swallowing-related muscles such as those in the submental suprahyoid region. 
Comparator Agent  Standard Postop Physiotherapy  Standard Post operative physiotherapy exercises which include chin tuck, head turns, and supraglottic swallow will be advised to the individuals in the control group. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Primary respectable tumor of Tongue.
2. Histologically proven SCC of Tongue.
3. Patient undergoing Compartmental, Subtotal, Near Total Glossectomies.
 
 
ExclusionCriteria 
Details  1. Chronic radiation exposed patients of Tongue carcinoma.
2. Recurrent/ Relapsed and metastatic patients/ Unresectable cases.
3. Neurological disorders affecting swallowing, Prior swallowing impaired or Severe dysphagia patients.
4. Severe Cardiopulmonary conditions impacting expiratory efforts.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in MEP (cm H20) from baseline to 4weeks  2years 
 
Secondary Outcome  
Outcome  TimePoints 
1. Time to removal of Ryles Tube (days post-surgery)
2. Aspiration events in control vs treatment groups
3. QoL improvement (MDADI score) at 4 and 8 weeks .
4. Improvement in FEES-based Score at 4 and 8weeks.
 
2years 
 
Target Sample Size   Total Sample Size="98"
Sample Size from India="98" 
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/ Phase 3 
Date of First Enrollment (India)   27/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  27/01/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
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  

Global incidence trends in Head and Neck cancer worldwide. The overall incidence of HNC continues to rise, with a predict 30 percent increase annually by 2030. The majority of new cases of HNSCC annually are related to smoking and alcohol consumption with five year survival rate only approximately 50 percent . Surgery is an effective treatment for these patients. However dysphagia and aspiration occur frequently post operatively with Tongue cancer having majority of burden. The degree of dysphagia depends on the amount of normal tissue resected and they have a poor quality of life and develop anxiety and depression when they aspirate and become dependent on Tracheostomy Tube and Ryles tube.

We routinely provide standard exercise therapy post operatively like chin tuck or  head turns and supraglottic swallow. But despite notable refinements in swallow therapy over the last three decades attempts to reverse aspiration with swallowing therapy are often disappointing. Therefore new emerging devices like EMST means Expiratory muscle strength training device  are inexpensive and provide device driven exercise therapy. During EMST our task is to strengthen recruited muscles over time. EMST acts on one of two mechanisms one by Strengthening subglottic expiratory pressure generating forces, translating to a stronger cough to clear aspirate from the lower airway or  Improving airway closure for swallowing by exercise of swallowing related muscles such as those in the submental suprahyoid region.

Rationale of EMST device in HNC patients

In several populations to date EMST has been shown to increase expiratory pressure generation by 30 percent to 150percent with an average of 50 percent in a 4 weeks period of time. EMST is accordingly gaining popularity among various populations with swallowing disorders but to our knowledge the  results of EMST have not evaluated in Tongue patients. Thus the purpose of this study will be to examine the therapeutic potential of EMST among Post Glossectomy associated aspiration and dysphagia. We hypothesize that expiratory force generating capacity indicated by Maximum expiratory pressures and swallowing safety by Penetration or Aspiration measured by Functional endoscopic evaluation of swallowing  would improve after 4 weeks of EMST.

 
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