| CTRI Number |
CTRI/2020/06/025972 [Registered on: 18/06/2020] Trial Registered Prospectively |
| Last Modified On: |
12/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal |
| Study Design |
Other |
|
Public Title of Study
|
Use of WBC as an indicator to monitor different levels of oral input in stroke survivors with swallowing difficulties |
|
Scientific Title of Study
|
Profiling of infections related biomarker at different levels of FOIS in post stroke 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 |
Anamika Suresh |
| Designation |
Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
08056729719 |
| Fax |
|
| Email |
anamika.unique@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa N Devadiga |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9986447191 |
| Fax |
|
| Email |
deepa.n@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa N Devadiga |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9986447191 |
| Fax |
|
| Email |
deepa.n@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Anamika Suresh
Department of Speech and Hearing, Manipal College of Health Professions, Madhav Nagar, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Anamika Suresh |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Madhav Nagar, Manipal, Karnataka 576104 |
| 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 |
| Anamika Suresh |
Kasturba Hospital |
Department of Speech and Hearing, Department of Neurology, Kasturba Hospital, Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
08056729719
anamika.unique@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I633||Cerebral infarction due to thrombosis of cerebral arteries, (2) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Individuals in the age range above 18yrs of age
Individuals who are with first episode of stroke
|
|
| ExclusionCriteria |
| Details |
Individuals who are under G-tube, jejunostomy tube
Individuals with tracheostomy tube
|
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Biomarker- White Blood Count cells (WBC) levels and oral intake functioning of the client |
March 2021 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| oral intake functioning of the client |
March 2021 |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
03/08/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aims & objectives: The aim of the study is to profile of infections related
biomarker at different levels of FOIS in post stroke dysphagia.ObjectivesPrimary Objectives -To profile the
different levels of functional oral intake scale using the biomarker.-To compare presence and absence of infection at Level 1
and Level 7Secondary ObjectivesTo compare the biomarker between Level 1 and
Level 7 across the type of lesion and stroke.
|