CTRI Number |
CTRI/2017/10/010180 [Registered on: 24/10/2017] Trial Registered Prospectively |
Last Modified On: |
24/10/2017 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Studying cough in people with swallowing difficulties after stroke. |
Scientific Title of Study
|
Analysis of cough in post stroke individuals with dysphagia. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Carol Melanie Alvares |
Designation |
PG Student |
Affiliation |
School of Allied Health Science, Manipal University. |
Address |
Department of Speech and Hearing
SOAHS, Manipal University
Manipal.
Dakshina Kannada KARNATAKA 576104 India |
Phone |
9964978491 |
Fax |
|
Email |
carol_alvares@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Deepa Devadiga |
Designation |
Associate Professor |
Affiliation |
Department of Speech and Hearing SOAHS, Manipal University Manipal. |
Address |
Department of Speech and Hearing
SOAHS, Manipal University
Manipal.
Udupi KARNATAKA 576104 India |
Phone |
9986447191 |
Fax |
|
Email |
deepa.n@manipal.edu |
|
Details of Contact Person Public Query
|
Name |
Dr Deepa Devadiga |
Designation |
Associate Professor |
Affiliation |
Department of Speech and Hearing SOAHS, Manipal University Manipal. |
Address |
Department of Speech and Hearing
SOAHS, Manipal University
Manipal.
Hassan KARNATAKA 576104 India |
Phone |
9986447191 |
Fax |
|
Email |
deepa.n@manipal.edu |
|
Source of Monetary or Material Support
|
Kasturba Medical College,
Manipal University
Manipal, Karnataka. |
|
Primary Sponsor
|
Name |
Kasturba Medical College |
Address |
Department of Speech and Hearing
SOAHS, Manipal University
Manipal. |
Type of Sponsor |
Private medical college |
|
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 |
Carol Melanie Alvares |
Kasturba Medical College |
Department of Speech and Hearing
SOAHS, Manipal University
Manipal. Udupi KARNATAKA |
9964978491
carol_alvares@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics Committee, Kasturba Hospital, Manipal |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Stroke with Dysphagia adults., |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
41.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. Individuals with acute post stroke (Brain stem and Non Brain stem lesions)
2. Adults in the age range of 41-60 years (Erikson’s stages of psychosocial development, 1968).
3. Individuals who are on tube dependent for feed
|
|
ExclusionCriteria |
Details |
1. Tracheostomy/ Ventilator/ GCS less than 8
2. Neurodegenerative disorder, Gastrointestinal disorders
3. Unable to follow instructions (Aphasia/ Cognitive problems/ Hearing loss) |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Other |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Aim: To investigate the cough using acoustic analysis in individuals with dysphagia
OBJECTIVES:
To compare cough between pre and post swallow acoustically
To compare cough between pre and post swallow perceptually
|
6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Aim: To investigate the cough using acoustic analysis in individuals with dysphagia
OBJECTIVES:
To compare cough between pre and post swallow acoustically
To compare cough between pre and post swallow perceptually
|
6 months
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
31/10/2017 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Perry, L., & Love, C. P. (2001). Screening for dysphagia and aspiration in acute stroke: a systematic review. Dysphagia, 16(1), 7-18.
Hinchey, J. A., Shephard, T., Furie, K., Smith, D., Wang, D., Tonn, S., & Stroke Practice Improvement Network Investigators. (2005). Formal dysphagia screening protocols prevent pneumonia. Stroke, 36(9), 1972-1976
Smithard, D. G., ONeill, P. A., England, R. E., Park, C. L., Wyatt, R., Martin, D. F., & Morris, J. (1997). The natural history of dysphagia following a stroke. Dysphagia, 12(4), 188-193.
Leow LP, et al. The impact of dysphagia on quality of life in ageing and Parkinson’s disease asmeasured by the swallowing quality of life (SWAL-QOL) questionnaire. Dysphagia. 2010; 25(3):216–20.
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Dysphagia is closely associated with stroke, and
aspiration pneumonia is a main cause of death among stroke patients (Perry L,
et al., 2001; Hinchey J. A, et al., 2005). Dysphagia and related
complications increase length of acute stay and are associated with increased
mortality, comorbidity, and increased health care costs (Smithard et al.,
1997). In many neurogenic populations, dystussia (impaired cough) and
dysphagia are present in parallel (Mann et al,2000; Vellas et al ,2000), a
finding that is not surprising given the shared neural and anatomical
substrates of respiration, cough and swallowing function (Gestreauet,al 1996;
Pitts T et,al 2012; Troche et al, 2014).
An effective cough is critical in removing aspirated material from the
airway during swallowing, particularly in patients with additional
co-morbidities who are more susceptible to developing pulmonary sequelae. However
off late the cough testing in the clinical swallowing evaluation has also been a recent topic of interest
to provide information regarding mechanisms of airway safety and the physiologic
ability of an individual to defend their airway (Smith Hammond CA, et al. 2001;
Pitts T, et al.2008; Plowman EK, et al. 2016). Currently,
however, cough testing is not routinely incorporated in the CSE across all settings,
although there are several investigations probed into the cough, its different
types, aerodynamic analysis of cough. This study aims to investigate the cough
using acoustic analysis in individuals with dysphagia. A total of 30 participants will be recruited for the study and cough sample will be recorded before and after swallow with an Olympus Linear Pcm LS-P2 Voice Recorder placed approximately 10cm from the participant’s
mouth using the PRAAT software installed in the laptop. The participant will be instructed to cough voluntarily
on three trials. The best cough sample will be used for both perceptual and
acoustic analysis. Cough will be analysed perceptually on a
rating scale. Objectively the
cough samples will be analysed by computing the
Mel-Frequency Cepstral Coefficients (MFCC) and its derivatives with the help of
MATLAB tool.
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