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CTRI Number  CTRI/2024/06/068898 [Registered on: 13/06/2024] Trial Registered Prospectively
Last Modified On: 12/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the combined effect of dysphagia exercises on severity of dysphagia, swallowing ability and quality of life in patients of acute stroke with swallowing difficulty. 
Scientific Title of Study   To evaluate the combined effect of Mendelsohn maneuver and Shaker exercise on dysphagia severity, functional oral intake and swallowing ability in patients of acute stroke with dysphagia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jalat James 
Designation  PG Student 
Affiliation  College of Physiotherapy, PGIMS, Rohtak 
Address  Physiotherapy Department, E- Block, College of Physiotherapy, PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  9643694525  
Fax    
Email  jalatjames@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suman Mehra 
Designation  Assistant Professor 
Affiliation  College of Physiotherapy, PGIMS, Rohtak 
Address  Physiotherapy Department, Teaching Staff Room, E- Block, College of Physiotherapy, PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  8814063412  
Fax    
Email  sumanmehra2017@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suman Mehra 
Designation  Assistant Professor 
Affiliation  College of Physiotherapy, PGIMS, Rohtak 
Address  Physiotherapy Department, Teaching Staff Room, E- Block, College of Physiotherapy, PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  8814063412  
Fax    
Email  sumanmehra2017@gmail.com  
 
Source of Monetary or Material Support  
Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India, 124001 
 
Primary Sponsor  
Name  College of Physiotherapy PGIMS Rohtak 
Address  Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India, 124001 
Type of Sponsor  Government medical college 
 
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 Suman Mehra  Pt. B.D. Sharma, PGIMS  Neurology Department, Ward No: 32, Lala Shyamlal Super Speciality Block and Physiotherapy Department, E-Block, College of Physiotherapy, Pt. B.D. Sharma, PGIMS/UHS, Rohtak
Rohtak
HARYANA 		 8814063412

sumanmehra2017@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G819||Hemiplegia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional treatment  It will consist of oral strengthening exercise using straw and patient education regarding appropriate body posture and compensatory techniques to be adopted while eating/ swallowing. Dosimetry: 45 min per session twice a day for 2 weeks daily. 
Intervention  Mendelsohn maneuver and Shaker exercise  Mendelsohn maneuver: The patient will be asked to tuck his/ her chin and perform the swallowing motion while holding the larynx in an elevated position for 2-6 seconds. Shaker exercise: Isometric and isotonic component of Shaker exercise. Dosimetry: 45 min per session twice a day for 2 weeks daily. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Diagnosed patients of acute (up to two weeks post-stroke), stable stroke having difficulty in swallowing
2. Alert and cooperative patients without any cognitive deficit (having MMSE greater than twenty two)
 
 
ExclusionCriteria 
Details  1. Patients who have undergone pharyngeal surgical procedures of the strap muscles (mylohyoid, geniohyoid, anterior gastric, thyrohyoid muscle)
2. Patients who are unable to perform the exercise
3. Patients with tracheostomy tube
4. Patients with history of severe cervical spine disease
5. Patients with unstable medical condition
 
 
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 
Dysphagia Severity Rating Scale, Functional Oral Intake Scale, Eating Assessment Tool  At baseline (day 0), post intervention (week 2). Follow up will be done at week 4 and 3rd month. 
 
Secondary Outcome  
Outcome  TimePoints 
Dysphagia Handicap Index  At baseline (day 0), post intervention (week 2). Follow up will be done at week 4 and 3rd month. 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   27/06/2024 
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="1"
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  

Title: "To evaluate the combined effect of Mendelsohn maneuver and Shaker exercise on dysphagia severity, functional oral intake and swallowing ability in patients of acute stroke with dysphagia".

Methods/Design: This study is a double-blind, parallel group, active control, prospective and randomized controlled trial (RCT) investigating the effects of a 2-week supervised Mendelsohn maneuver and Shaker exercise on 20 patients of acute stroke and dysphagia. Main inclusion criteria are diagnosed acute (up to 2 weeks post stroke), stable stroke having difficulty in swallowing; alert and cooperative patients without any cognitive deficit (having MMSE > 22). The primary outcome measures are: Dysphagia Severity Rating Scale (DSRS), Functional Oral Intake Scale (FOIS) and Eating Assessment Tool (EAT-10). Secondary outcome measure include the Dysphagia Handicap Index (DHI). Participants randomized to the interventional group will participate in 2 supervised exercise sessions daily for 2 weeks. Participants randomized to the control group will receive oral strengthening exercise using straw and are taught about the compensatory measures to be adopted while eating swallowing.


Discussion: This RCT explores the combined effect of Mendelsohn maneuver and Shaker exercise in patients of acute stroke with dysphagia. Results will contribute to a better understanding of combined effect of Mendelsohn maneuver and Shaker exercise and inform intervention programs that will optimally improve physiological and psychosocial health in patients of acute stroke with dysphagia, and that are ultimately aimed at improving prognosis. The study results will contribute to the design of better rehabilitation programs for patients of acute stroke with dysphagia.



 
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