| CTRI Number |
CTRI/2021/09/036170 [Registered on: 02/09/2021] Trial Registered Prospectively |
| Last Modified On: |
25/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing swallowing related quality of life in patients with stroke. |
|
Scientific Title of Study
|
Assessing dysphagia related Quality of Life using Dysphagia Handicap Index in stroke survivors |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sai Sreya R |
| Designation |
Student |
| Affiliation |
MCHP, MAHE, Manipal |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9884003683 |
| Fax |
|
| Email |
ssreya.india@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa N Devadiga |
| Designation |
Associate Professor |
| Affiliation |
MCHP, MAHE, Manipal |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986447191 |
| Fax |
|
| Email |
deepa.n@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sai Sreya R |
| Designation |
Student |
| Affiliation |
MCHP, MAHE, Manipal |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9884003683 |
| Fax |
|
| Email |
ssreya.india@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Madhav Nagar, Manipal, Udupi - 576104 |
|
|
Primary Sponsor
|
| Name |
Sai Sreya R |
| Address |
MCHP, MAHE, Manipal |
| 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 |
| Sai Sreya R |
Kasturba Hospital |
Department of Neurology, Kasturba Hospital, Madhav Nagar, Manipal.
Udupi
KARNATAKA |
9884003683
ssreya.india@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: G968||Other specified disorders of central nervous system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with good comprehension
Individuals 15 days post NG tube removal
Individuals who are on oral feed
|
|
| ExclusionCriteria |
| Details |
Individuals with Tracheostomy during the time of assessment
History of dysphagia before stroke
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Dysphagia Handicap Index scores will be obtained in the following domains –
Physical domain scores
Functional domain scores
Emotional domain scores
|
32 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate site of lesion with dysphagia severity |
32 weeks |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
10/09/2021 |
| 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="8"
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)?
Response - NO
|
|
Brief Summary
|
Justification for study - Dysphagia is a commonly reported consequence of stroke and has a negative effect on all aspects of a person’s life, including physical, emotional and social aspects. Due to the long lasting effects of dysphagia, it is necessary to evaluate the dysphagia related Quality of life on stroke survivors. Thus, a dysphagia related Quality of life assessment is essential to ensure satisfactory Quality of life and prevent further medical complications and should have a high priority in health-care practices. There are no studies that have reported the psychosocial impact of dysphagia using the Kannada version of DHI among the stroke survivors and correlate with type of lesion, and hence the present study is in this direction. Aim - To assess Dysphagia related QOL using DHI in Stroke Survivors |