| CTRI Number |
CTRI/2025/01/079763 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Therapeutic] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of semi-occluded vocal tract exercise to improve voice quality of
Dysarthria patient |
|
Scientific Title of Study
|
Effectiveness of Semi occluded vocal tract exercise (SOVTE) on voice quality among Dysarthria patient |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Joynab Bente Karim |
| Designation |
Student |
| Affiliation |
Bangladesh Health Professions Institute |
| Address |
Speech and language therapy department,CRP, Savar, Dhaka, Bangladesh
1343
Other |
| Phone |
01856103778 |
| Fax |
|
| Email |
hridimoni12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjida Subahan |
| Designation |
Assistant Professor, Bangladesh Health Professions Institute |
| Affiliation |
Bangladesh Health Professions Institute |
| Address |
Speech and language therapy department,CRP, Savar, Dhaka, Bangladesh
1343
Other |
| Phone |
01682990501 |
| Fax |
|
| Email |
sanjidaslt93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjida Subahan |
| Designation |
Assistant Professor, Bangladesh Health Professions Institute |
| Affiliation |
Bangladesh Health Professions Institute |
| Address |
Speech and language therapy department,CRP, Savar, Dhaka, Bangladesh
1343
Other |
| Phone |
01682990501 |
| Fax |
|
| Email |
sanjidaslt93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangladesh health professions institute,SAVAR,DHAKA,BANGLADESH |
|
|
Primary Sponsor
|
| Name |
Joynab Bente Karim |
| Address |
Mirpur 2,Dhaka,Bangladesh |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjida Subahan |
Hospital |
Centre For The
Rehabilitation Of The
Paralyzed (CRP),
savar, Dhaka,
Bangladesh
|
01682-990501
sanjidaslt93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R471||Dysarthria and anarthria, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Semi-occluded vocal tract
exercise |
patient will receive SOVTE for
12 days |
| Comparator Agent |
semi-occluded vocal tract
exercise among Dysarthria patient in
voice quality |
patient will receive 12 days
treatment |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Stroke with dysarthria patient with voice problem diagnosed by SLT.
2. Both male and female
3. patient who are willing to participate.
4. Age range 15/80
|
|
| ExclusionCriteria |
| Details |
1. Patient with severe and critical condition
2. Undiagnosed injury or other condition
3. Patient who will unwilling to participate in this study will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effectiveness of SOVTE among Dysarthria patient
with voice difficulties |
At base line,2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
By using GRBAS scale i will measure the patient
phonation, resonance. loudness, grade,
roughness, breathiness, asthenia and strain. |
12 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="0"
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 2 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
| According to my research i will find out the effectiveness of SOVTE on voice quality among Dysarthria patients . i will give 12 days therapeutic treatment session to the selective patient, by using GRBAS scale a senior CSLT will assessment the patient voice quality and select patient for treatment by doing this exercise i wil find out the patient phonation, resonance, loudness, grade, roughness, breathiness, asthenia and strain. |
|