| CTRI Number |
CTRI/2018/07/014985 [Registered on: 20/07/2018] Trial Registered Prospectively |
| Last Modified On: |
19/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Adaptation and Validation of ‘Quality of life in Dysarthric speaker (QoL-DyS) Scale’ to Malayalam language. |
|
Scientific Title of Study
|
Cross-cultural Adaptation and Validation of ‘Quality of life in Dysarthric speaker (QoL-DyS) Scale’ to Malayalam |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ROSHIN RAJ PALASSERIL |
| Designation |
STUDENT |
| Affiliation |
MANIPAL ACADEMY OF HIGHER EDUCATION |
| Address |
DEPARTMENT OF SPEECH AND HEARING,SOAHS,MANIPAL ACADEMY OF HIGHER EDUCATION,MANIPAL,KARNATAKA
Udupi
KARNATAKA
576104
India |
| Phone |
9746465213 |
| Fax |
|
| Email |
roshinrose94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSunila John |
| Designation |
Associate Professor |
| Affiliation |
MANIPAL ACADEMY OF HIGHER EDUCATION |
| Address |
DEPARTMENT OF SPEECH AND HEARING,SOAHS,MANIPAL ACADEMY OF HIGHER EDUCATION,MANIPAL,KARNATAKA
Udupi
KARNATAKA
576104
India |
| Phone |
9746465213 |
| Fax |
|
| Email |
sunila.john@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
ROSHIN RAJ PALASSERIL |
| Designation |
STUDENT |
| Affiliation |
MANIPAL ACADEMY OF HIGHER EDUCATION |
| Address |
DEPARTMENT OF SPEECH AND HEARING,SOAHS,MANIPAL ACADEMY OF HIGHER EDUCATION,MANIPAL,KARNATAKA
Udupi
KARNATAKA
576104
India |
| Phone |
9746465213 |
| Fax |
|
| Email |
roshinrose94@gmail.com |
|
|
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 |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sunila John |
DEPARTMENT OF SPEECH AND HEARING,SOAHS,MANIPAL ACADEMY OF HIGHER EDUCATION,MANIPAL,KARNATAKA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sunila John |
School of Allied Health Sciences |
Department of Speech and Hearing,Kasturba Hospital, Manipal,Karnataka.
Udupi
KARNATAKA |
9986206894
sunila.john@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC AND KH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Individuals with Dysarthria, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Confirmed diagnosis of presence of Dysarthria by an experienced speech language pathologist
2.Age between 18 years – 55 years
3.Presence of at least a mild-moderate communication disorder marked by a decrease in intelligibility
4.Ability of the participant to respond to basic yes/no questions verbally
5.Cognitive abilities of the participants should be normal and this will be assessed using Mini-Mental State Examination [MMSE]. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition
6.Patients attending speech and language intervention
|
|
| ExclusionCriteria |
| Details |
1.Patients with associated conditions like aphasia, hearing impairment, visual impairment and dementia
2.Patients with medical conditions such as heart diseases, acquired immunodeficiency syndrome(AIDS), carcinoma or other chronic illness’ which may otherwise impact QoL and interferes with the assessment procedure will be excluded
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of Life scores on four outcome measures |
The measures will be analysed after completion of data collection by November 2018 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
20/07/2018 |
| 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="3"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The adapted 40 item self-report questionnaire will be administered on the participants. The participants with motor disabilities will be allowed to take assistance from family members or the investigator for marking the scores, if required. The participants will be recruited from vrious hospitals in Kerala. |