| CTRI Number |
CTRI/2024/09/074506 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing between Normal and Tongue Hold Swallow in Healthy Adults using Ultrasound Imaging |
|
Scientific Title of Study
|
Comparison of Normal and Tongue Hold Swallow Dynamics in Healthy Adults - An Ultrasound 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 |
Delisha Dias |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, 6th floor, LH5 Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9353781995 |
| Fax |
|
| Email |
delisha.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venkataraja Aithal Udupi |
| Designation |
Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Ground floor, Office of the Dean, room no. 005, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9380495415 |
| Fax |
|
| Email |
vrajaithal@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venkataraja Aithal Udupi |
| Designation |
Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Ground floor, Office of the Dean, room no. 005, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9380495415 |
| Fax |
|
| Email |
vrajaithal@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal, Udupi, Karnataka, 576104, India |
|
|
Primary Sponsor
|
| Name |
Delisha Dias |
| Address |
Department of Speech and Hearing, 6th floor, LH5 Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, 576104, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Rajagopal KV |
Kasturba Hopsital |
Department of Radiodiagnosis and Imaging, Ground floor, room no. 12, Baliga block, Kasturba hospital, Madhav Nagar, Manipal, 576104
Udupi
KARNATAKA |
9448158901
rajagopal.kv@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy participants of 20 to 50 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Normal individuals with no swallowing issues.
2. Age range between 20-50 years.
3. Individuals who can follow the number of trials of the given tasks. |
|
| ExclusionCriteria |
| Details |
1. Individuals associated with neurological conditions such as neurodegenerative, neurogenetic, neurodevelopmental, and cerebrovascular disorders.
2. Individuals associated with swallowing problems. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome measures are the variables considered by ultrasound imaging,
1. Lateral pharyngeal wall motion of duration (secs) and displacement (cm) of the initial and end LPW motion during normal and THS.
2. Hyoid-larynx approximation of thyroid cartilage to hyoid bone distance during normal and THS in cm.
3. Tongue thickness of vertical distance measured in a static position from the mylohyoid muscle surface to the tongue dorsum in cm. |
Cross-sectional study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="29"
Sample Size from India="29"
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)
|
01/10/2024 |
| 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="10"
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
|
Title: Comparison of Normal and Tongue Hold Swallow Dynamics in Healthy Adults – An Ultrasound Study Type of Study: Prospective study- cross sectional study Aim: To compare ultrasound measures of normal and tongue hold swallow in healthy adults. Objectives: 1) To analyze and compare lateral pharyngeal wall motion and hyoid bone approximation during normal and tongue hold swallow in healthy adults. 2) To analyze tongue thickness in static position in healthy adults. Justification: - Ultrasound technique being a simple clinically doable procedure as against VFS, EMG and also having no exposure to radiation, its application in routine clinical settings is most warranted in today’s clinical practice. Ultrasound is helpful in real time observation of anatomical and physiological function while swallowing.
Sample size: Total number of 29 participants
Materials and methods: Ultrasound for the comparison of normal and tongue hold swallow in heathy adults focusing on the parameters of lateral pharyngeal wall motion and hyoid bone approximation. Tongue thickness is analyzed at static position. Inclusion and exclusion criteria:Inclusion criteria:- Normal individuals with no swallowing issues
- Age range between 20-50 years
- Individuals who can follow the number of trials of the given tasks.
Exclusion criteria: - Individuals associated with neurological conditions such as neurodegenerative, neurogenetic, neurodevelopmental and cerebrovascular disorders.
- Individuals associated with swallowing problems.
Procedure: - Obtain permissions and approvals.
- Recruit participants meeting inclusion criteria.
- Informed written consent will be taken.
- Ultrasound testing procedure will be carried by a qualified radiologist in presence of qualified SLP and the participants will be instructed to participant to the two types of the swallow normal and tongue hold swallow.
- Three parameters will be analysed: Lateral pharyngeal wall motion, hyoid-larynx approximation and tongue thickness at static
- Image analysis of the 3 parameters
Outcome measures: The variables considered by ultrasound imaging including - lateral pharyngeal wall motion of duration (secs) and displacement (cm) of the initial and end LPW motion during normal and THS,
- hyoid – larynx approximation of thyroid cartilage to hyoid bone distance during normal and THS in cm
- tongue thickness of vertical distance measure in a static position from the mylohyoid muscle surface to the tongue dorsum in cm.
Potential risks and benefits: A minor increase over minimal risk is anticipated in terms of discomfort and anxiety during the tasks and procedure. Indirect benefit is present as Ultrasound can be used both in screening and biofeedback techniques in dysphagia. This will help clinicians to understand swallowing dynamics and further formulate and plan swallowing intervention strategies. To understand the swallowing mechanism during both the swallowing conditions i.e. normal swallow and tongue hold swallow.
Literature Review:
Studies reported on tongue-hold swallow using manometry, electromyography, and VFS to examine the physiological function of swallowing (Aoyagi et.al., 2021). Studies on hyoid larynx approximation in stroke patients with or without dysphagia using ultrasonographic examination (Huang et.al 2009), where individuals who had strokes, the group with dysphagia had a lesser hyoid-larynx approximation than the group without dysphagia.
The tongue thickness of the ALS patients was correlated with both onset type and body mass index (Nakamori et. al 2015) Ultrasonography was used to examine lateral pharyngeal wall (LPW) motion (Hyung Kim & Sun Kim 2012).
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