| CTRI Number |
CTRI/2018/08/015370 [Registered on: 17/08/2018] Trial Registered Prospectively |
| Last Modified On: |
30/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of movement of the upper part of foodpipe during dry and wet swallow in persons following removal of voicebox with and without swallowing difficulties- an exploratory study |
|
Scientific Title of Study
|
Biomechanics of pharyngoesophageal segment during dry and wet swallow in persons with total laryngectomy with and without dysphagia- an exploratory study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
G Harsha Raj |
| Designation |
Student |
| Affiliation |
School of allied health sciences, MAHE, Manipal |
| Address |
Department of Speech and Hearing, SOAHS, Manipal Academy of Higher Education, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9731233356 |
| Fax |
|
| Email |
harsha.rg17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venkataraja Aithal |
| Designation |
Professor |
| Affiliation |
School of allied health sciences, MAHE, Manipal |
| Address |
Department of speech and hearing, School of Allied health sciences, Manipal Academy of Higher Education, Manipal, Karnataka
Department of speech and hearing, School of Allied health sciences, Manipal Academy of Higher Education, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9448824363 |
| Fax |
|
| Email |
vrajaithal@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venkataraja Aithal |
| Designation |
Professor |
| Affiliation |
School of allied health sciences, MAHE, Manipal |
| Address |
Department of speech and hearing, School of Allied health sciences, Manipal Academy of Higher Education, Manipal, Karnataka
Department of speech and hearing, School of Allied health sciences, Manipal Academy of Higher Education, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9448824363 |
| Fax |
|
| Email |
vrajaithal@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal, Karnataka,576104 |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF SPEECH AND HEARING |
| Address |
SCHOOL OF ALLIED HEALTH SCIENCES, MANIPAL ACADEMY OF HIGHER EDUCATION, MANIPAL, KARNATAKA |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| G Harsha Raj |
Amritha Institute of Medical Sciences |
Amrita Institute of Medical Sciences and Research Centre
Ponekkara, P. O Kochi,
Kerala 682 041, India
Ernakulam
KERALA |
9731233356
harsha.rg17@gmail.com |
| G Harsha Raj |
Nitte Institute of Speech and Hearing |
Justice KS Hegde Charitable Hospital, Deralakatte,
Mangalore – 575018
Karnataka, India
Dakshina Kannada
KARNATAKA |
9731233356
harsha.rg17@gmail.com |
| G HARSHA RAJ |
Regional Cancer Center, Trivandrum |
Regional Cancer Center, Medical College Campus, Medical College Road, Thiruvananthapuram, Kerala 695011
Thiruvananthapuram
KERALA |
9731233356
harsha.rg17@gmail.com |
| G HARSHA RAJ |
SCHOOL OF ALLIED HEALTH SCIENCES, KASTURBA HOSPITAL |
3rd Floor, CTC building,DEPARTMENT OF SPEECH AND HEARING, KASTURBA HOSPITAL, MANIPAL, KARNATAKA
Udupi
KARNATAKA |
9731233356
harsha.rg17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| KMC and KH Institutional Ethics Committee |
Approved |
| KMC and KH Institutional Ethics Committee |
Approved |
| KMC and KH Institutional Ethics Committee |
Approved |
| KMC and KH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R131||Dysphagia, (2) ICD-10 Condition: R131||Dysphagia, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Person with pure case of total laryngectomy
Participants with good comprehension.
Persons who have started on oral feeds
|
|
| ExclusionCriteria |
| Details |
Presence of any neuromotor impairment affecting swallowing skills.
Significant post- operative dysphagia or prosthesis related issues of swallowing.
Significant post- operative complications such as prosthesis related issues of swallowing
Patients with aspiration
Structural and functional deficits of oral cavity.
Excessive fat deposition in the cervical area.
Excessive hair growth in cervical area.
Skin allergy in the neck region.
Sensory impairments: hearing and tactile.
Person is not willing to accept the food provided |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The data on biomechanics of pharyngoesophageal segment during dry and wet swallowing in alaryngeal speakers can be used to identify swallowing issues post operatively in routine clinical setting through a simple non-invasive radiation-freebiomechanics study.This method can be used for screening purpose and for early diagnosis of swallowing issues. Findings of this study would help in planning client specific interventions as well as for further documenting their progress. |
1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "23"
Final Enrollment numbers achieved (India)="23" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/08/2018 |
| Date of Study Completion (India) |
20/02/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/02/2019 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet decided |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Aim of the current study is to investigate the biomechanics of pharyngoesophageal (PE) segment in persons with total laryngectomy, with and without dysphagia, through the analysis of the amplitude, onset and duration of movement of PE segment during dry and wet swallow The biomechanics of pharyngoesophageal segment will be studied through dry swallow and wet swallow which includes swallowing of solid liquid and semisolid diet The current study will be conducted on persons with total laryngectomy presenting with and without dysphagia, visiting the following hospital during the course of study: Kasturba Hospital, Manipal Amrita Institute of Medical Sciences (AIMS), Kochi Justice KS Hegde Charitable Hospital, Mangalore Regional Cancer Centre, Trivandrum The sample consists of persons who underwent total laryngectomy with a post operative duration of minimum of 3 months with no major issues in swallowing. Persons who can perform dry and wet swallowing will be considered. Non invasive surface electromyography is used to test the participants. Trials include dry swallow and wet swallow which includes solid, semi solid and liquid consistencies. 1 tablespoon (10 ml) of liquid (pure water) & semisolid (porridge) and 1 teaspoon of solid (upma) will be given. Initially, a series of practice trial will be given to confirm the nature of swallow followed by which test begins and data obtained will be further subjected to analysis of measures of biomechanics. The following parameters of biomechanics of swallowing will be analysed: Amplitude (mV) ,onset (msec) and Duration (sec) This data can be used to identify swallowing problems in persons with laryngectomy post surgically in routine clinical situations This would help in planning client specific interventions and documenting the progress in a hierarchical manner. The study would be useful to understand the nature of swallowing biomechanics of PE segment in persons with total laryngectomy with dysphagia in comparison with those without dysphagia.
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