| CTRI Number |
CTRI/2023/11/060345 [Registered on: 29/11/2023] Trial Registered Prospectively |
| Last Modified On: |
15/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Wearable electronics for swallow-graphy in stroke patients
|
|
Scientific Title of Study
|
Wearable electronics for swallow-graphy in stroke patients |
| Trial Acronym |
WESTRO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Awadh Kishor Pandit |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
Room number 703, Neuroscience Center, Department of Neurology, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
akpandit.med@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Awadh Kishor Pandit |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
Room number 703, Neuroscience Center, Department of Neurology, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
akpandit.med@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Awadh Kishor Pandit |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
Room number 703, Neuroscience Center, Department of Neurology, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
akpandit.med@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, New Delhi
Indian Institute of Technology Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences |
| Address |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Indian Institute of Technology Delhi |
IIT Delhi Main Rd, IIT Campus, Hauz Khas, New Delhi, Delhi 110016 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Awadh Kishor Pandit |
All India Institute Of Medical Sciences |
Room number 703, Neuroscience Center, Department of Neurology, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East
South
DELHI |
01126594049
akpandit.med@gmail.com |
| Dr Deepak Joshi |
Indian Institute of Technology Delhi |
Centre for Biomedical Engineering
Block II, Room No: 299- A, IIT Delhi Main Rd, IIT Campus, Hauz Khas, New Delhi, Delhi 110016
South
DELHI |
01126591155
Deepak.Joshi@cbme.iitd.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS, New Delhi |
Approved |
| Institute Ethics Committee IIT - Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers agreeing to be a part of the study without any swallowing dysfunction. |
| Patients |
(1) ICD-10 Condition: R131||Dysphagia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
FOR PATIENTS:
- Age between 18-80 years
- Persistent swallowing difficulty in ischemic or hemorrhagic stroke patients, at two weeks of onset of stroke or beyond.
- Both male and female genders will be included
FOR CONTROLS:
- Participants; healthy patient’s attendants’ or patients referred for barium swallow assessment/video fluoroscopy and noted to have normal swallowing functions and consenting for the study will be included
- Age (±5 years) and gender matched
|
|
| ExclusionCriteria |
| Details |
FOR PATIENTS:
- Patients will be excluded if not consenting will be excluded
- Patients who are in altered sensorium, comatose, on mechanical ventilation support and malignant infarction
- Patients having severe disabling co-morbidities, throat disease causing swallowing difficulty.
- Patients allergic to contrast/barium used for video-fluoroscopy/barium swallow.
FOR CONTROLS:
- Patients will be excluded if not consenting will be excluded
- Patients who are in altered sensorium, comatose, on mechanical ventilation support and malignant infarction
- Patients having severe disabling co-morbidities, throat disease causing swallowing difficulty.
- Patients allergic to contrast/barium used for video-fluoroscopy/barium swallow
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Development of a diagnostic tool to detect swallowing dysfunction in cases with stroke and pilot data for clinical assessment.
|
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Objective measurement of swallowing with a new metric based on the data from developed tool. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
08/12/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Swallowing dysfunction in stroke patients is a major burden and 30% more mortality is observed in such cases. Swallowing assessment should be done repeatedly to assure that the patients is doing well before oral feeding is initiated. There are existing methods to assess swallowing in stroke patients such as; bedside clinical assessment, video-fluoroscopy, barium swallow. Video-fluoroscopy/Barium swallow is gold standard for evaluation of swallowing dysfunction. These existing methods are provocative and may lead to aspiration, also it is not feasible to conduct these tests repeatedly. Expert specialists or trained healthcare workers are required to perform these tests on patients. Hence, there is pressing need of a non-invasive device which can detect swallowing dysfunction, also a device which can be used repeatedly to determine the status of swallowing dysfunction. This device can also be used by non-healthcare worker or patient’s attendants; it will not require any special training. To our knowledge there is no such device which is being used globally. For these reasons we propose to conduct this study to determine the efficacy of the non-invasive developed tool in testing swallowing difficulty in stroke patients. |