| CTRI Number |
CTRI/2026/01/101904 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| 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
|
EFFECT OF MASAKO MANEUVER AND MENDELSOHN MANEUVER ON IMPROVING SWALLOWING FUNCTION IN STROKE PATIENTS WITH DYSPHAGIA: A COMPARATIVE STUDY |
|
Scientific Title of Study
|
EFFECT OF MASAKO MANEUVER AND MENDELSOHN MANEUVER ON IMPROVING SWALLOWING FUNCTION IN STROKE PATIENTS WITH DYSPHAGIA: A COMPARATIVE STUDY |
| 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 Nasir Azarpasha Khairate |
| Designation |
Masters of Neurophysiotherapy student |
| Affiliation |
Maharashtra Institute of Physiotherapy latur |
| Address |
Department of Neurophysiotherapy, OPD-16, Maharashtra Institute of Physiotherapy, MIMSR Medical campus Ambejogai Road Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
7620573857 |
| Fax |
|
| Email |
nasirkhairate2016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parag Narayankar |
| Designation |
Associate Professor Department of Neurophysiotherapy |
| Affiliation |
Maharashtra Institute of Physiotherapy latur |
| Address |
Department of Neurophysiotherapy, OPD-16, Maharashtra Institute of Physiotherapy, MIMSR Medical campus Ambejogai Road Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
8600006655 |
| Fax |
|
| Email |
paragnarayankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parag Narayankar |
| Designation |
Associate Professor Department of Neurophysiotherapy |
| Affiliation |
Maharashtra Institute of Physiotherapy latur |
| Address |
Department of Neurophysiotherapy, OPD-16, Maharashtra Institute of Physiotherapy, MIMSR Medical campus Ambejogai Road Latur
MAHARASHTRA
413531
India |
| Phone |
8600006655 |
| Fax |
|
| Email |
paragnarayankar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neurophysiotherapy Department OPD no-16 Maharashtra Institute of Physiotherapy, MIMSR campus, Ambejogai Road latur 413513,Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute of Physiotherapy,Latur |
| Address |
Department of Neurophysiotherapy, OPD-16, Maharashtra Institute of Physiotherapy, MIMSR Medical campus Ambejogai Road Latur |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nasir Azarpasha Khairate |
Maharashtra Institute of Physiotherapy latur |
Department of Neurophysiotherapy, OPD-16, Maharashtra Institute of Physiotherapy, MIMSR Medical campus Ambejogai Road Latur
Latur
MAHARASHTRA |
07620573857
nasirkhairate2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1. Mendelsohn Maneuver with Neuromuscular electrical stimulation: 3 times per day, 5 days per week, for 4 weeks. |
Start with prepare to swallow saliva as you swallow place finger on throat to feel the larynx move up. When larynx reaches its highest position, pause and hold it therefor 3-5 second after holding allows the larynx to relax and finish swallowing. 3 sets of 10 repetitions, 3 times per day ,5 days per week, for 4 weeks.
Neuromuscular electrical stimulation:
frequency of 30Hz, duration of 100ms, intensity increased till minimal palpable observable contraction and interrupted direct current.
Pts. Position-supine and pillow under head, inactive electrode-on nape of neck, active pen electrode on pharyngeal muscle either side of hyoid bone for 5 days per week for 4 weeks.
|
| Intervention |
1.Masako Maneuver with Neuromuscular electrical stimulation: 3 times per day, 5 days per week, for 4 weeks. |
Ask the patient to protrude the tongue between the front teeth, holding it in place by gently biting down on the anterior portion of the tongue, and maintain this posture while swallowing saliva, this exercise was performed for 3 sets of 10 repetitions, 3 times per day, 5 days per week, for 4 weeks.
Neuromuscular electrical stimulation: frequency of 30Hz, duration of 100ms, intensity increased till minimal palpable observable contraction and interrupted direct current. Pts. Position-supine and pillow under head, inactive electrode-on nape of neck, active pen electrode on pharyngeal muscle either side of hyoid bone for 5 days per week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Acute and subacute stroke patients with dysphagia.
2.Male and Female with 40-70 Year age group.
3. Mild to Moderate dysphagia (EAT -10 Scale)
4. Medically stable
5.Able to sit upright during therapy
6.Willingness to provide informed consent and participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Severe cognitive impairment affecting participation
2. Patients with tracheostomy
3.Patients with gastrostomy tube
4.Structural abnormality or head and neck cancer affecting swallowing
5.Severe aphasia or communication disorder
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EAT -10 Scale |
At pre and post after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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
|
N/A |
|
Date of First Enrollment (India)
|
04/02/2026 |
| 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
|
Subject will be screened as per Inclusion and exclusion criteria. Aim, objectives and treatment procedure will be explained to the participant. written consent will be taken. then participant randomly allocated into two group. group A and group B. Necessary data will be taken from participants on data collection sheet. Group A: Masako Maneuver along with neuromuscular Electrical Stimulation Masako Maneuver - ask the patient to protrude the tongue between front teeth holding it in place by gently biting down on anterior portion of the tongue and maintain this posture while swallowing saliva, this exercise will be performed for 3set of 10 repetitions, 3 times per day, 5 days per week for 4 weeks.
Group B: Mendelsohn Maneuver along with Neuromuscular Electrical Stimulation Mendelsohn Maneuver: Start with prepare to swallow saliva as you swallow place the finger on throat to feel the larynx moves up when larynx reaches its highest position pause and hold it therefor 3-5 second after holding allows the the larynx to relax and finish swallowing. 3 set of 10 repetition ,3 times per day, 5days per week for 4 weeks.
Neuromuscular Electrical Stimulation- this the baseline treatment given for both the group. patient position -supine and pillow under the head, inactive electrode on nape of neck, active pen electrode on pharyngeal muscle on either side of hyoid bone . frequency 30Hz, Duration of 100ms, intensity increased till visible contraction and interrupted direct current used.
Data of both the group collected after the post intervention duration of 4 weeks and statistical analysis will be performed.
|