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CTRI Number  CTRI/2022/09/045681 [Registered on: 20/09/2022] Trial Registered Prospectively
Last Modified On: 02/09/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Swallowing]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to strengthen swallowing in the elderly population 
Scientific Title of Study   Effect of skill training on the motor learning of Isometric Shaker’s Exercise in elderly individuals with self-reported swallowing difficulty 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Thejaswi D 
Designation  Dr TMA Pai Research Scholar 
Affiliation  Kasturba Medical College 
Address  Department of Audiology and Speech Language Pathology, Kasturba Medical College, Lighthouse Hill Road

Dakshina Kannada
KARNATAKA
575001
India 
Phone  8147461160  
Fax    
Email  thejaswi.d1@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Radish Kumar Balasubramanium 
Designation  Professor 
Affiliation  Kasturba Medical College 
Address  Department of Audiology and Speech Language Pathology, Kasturba Medical College, Lighthouse Hill Road

Dakshina Kannada
KARNATAKA
575001
India 
Phone  6361212929  
Fax    
Email  radheesh.slp@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Thejaswi D 
Designation  Dr TMA Pai Research Scholar 
Affiliation  Kasturba Medical College 
Address  Department of Audiology and Speech Language Pathology, Kasturba Medical College, Lighthouse Hill Road

Dakshina Kannada
KARNATAKA
575001
India 
Phone    
Fax    
Email  thejaswi.d1@learner.manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College Hospital, Attavar, Mangalore, Karnataka - 575001 
 
Primary Sponsor  
Name  Thejaswi D 
Address  5th floor, Dept. of Audiology & SLP, Kasturba Medical College, Lighthouse Hill Road, Mangalore, Karnataka, India - 575001 
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 
Thejaswi D  Kasturba Medical College Hospital  5th floor, Dept. of Audiology & Speech Language Pathology, Attavara, Mangalore
Dakshina Kannada
KARNATAKA 		 8147461160

thejaswi.d1@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  With self reported swallowing difficuties 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Practice Distribution  Isometric Shakers Exercise will be practiced in a massed exercise format 
Comparator Agent  Practice Distribution  Isometric Shakers Exercise will be practiced in distributed exercise format 
Intervention  Practice Schedule   Isometric Shaker Exercise will be practiced in a blocked exercise format 
Comparator Agent  Practice Schedule  Isometric Shakers Exercise will be practiced in a random exercise format 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Individuals within 60 to 75 years who meet below listed criteria will be enrolled.
1. >3 score in Eating Assessment Tool
2. >5 score in Dysphagia Handicap Index
3. >26 score on Mini Mental Status Examination
4. Read English or Kannada 
 
ExclusionCriteria 
Details  Elderly individuals who present with below listed conditions will be excluded.
1. Surgery to head and neck
2. Neurological conditions
3. Cognitive-communicative disorders
4. Recurring neck pain
5. Cardiac pacemaker users
6. Seizure disorders
7. Currently under non-oral feeds 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary swallow outcome measures will be measured for 5 and 10-ml liquid thin barium during the videofluoroscopic study of swallowing procedure. The primary swallow outcome measures (unit) are:
1. Peak anterior hyoid excursion (mm)
2. Peak superior hyoid excursion (mm)
3. Upper oesophageal sphincter opening (mm) 		 The three-time points for assessing primary swallow outcome measures are
1. Pre-skill straining or 24 hours before motor learning Isometric Shakers Exercise
2. Post-skill training or after completing two weeks of motor learning Isometric Shakers Exercise
3. Post-detraining or two weeks after cessation of motor learning of Isometric Shakers Exercise 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome measures of the study are:
1. Borgs CR10 rating scale of exertion for estimating physical exertion during motor learning of Isometric Shakers Exercise
2. Training rating scale for measuring comfort and difficulties during motor learning of Isometric Shakers Exercise 		 The three-time points for assessing secondary swallow outcome measures are
1. Pre-skill training or 24 hours before motor learning of Isometric Shakers Exercise
2. Post-skill training or after completing two weeks of motor learning of Isometric Shakers Exercise
3. Post-detraining or two weeks after cessation of motor learning of Isometric Shakers Exercise 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   21/09/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not applicable. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The primary objective of the study is to evaluate and compare the effects of two weeks of skill training on the motor learning of Isometric Shakers Exercise using: (1) blocked and random practice schedule; and (2) massed and distributed practice distribution, on peak anterior and superior hyoid excursion and upper oesophageal sphincter opening in elderly individuals with self-reported swallowing difficulty. The secondary objectives of the study are to investigate the effects of two weeks of detraining from Isometric Shakers Exercise on the retention of gained peak anterior and superior hyoid excursion and upper oesophageal sphincter opening among elders who have completed two weeks of motor learning of Isometric Shakers Exercise.

 
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