| CTRI Number |
CTRI/2023/12/060634 [Registered on: 21/12/2023] Trial Registered Prospectively |
| Last Modified On: |
20/12/2023 |
| 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
|
semi-occluded vocal tract exercise (SOVTE) to improve the voice quality of Cervical spinal cord injury patient. |
|
Scientific Title of Study
|
effectiveness of semi occluded vocal tract exercise (SOVTE) in voice quality among cervical spinal cord injury (CSCI )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 |
Maria Akter Ritu |
| Designation |
Student of speech and language therapy |
| Affiliation |
Bangladesh Health Professions Institute |
| Address |
shariyatpur, noria, puran dinat hut
department-speech and language therapy, chapain, Savar, Dhaka
bangaldesh
8020
Other |
| Phone |
01627315566 |
| Fax |
|
| Email |
aloafsara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nure Naznin Nipa |
| Designation |
Assistant Professor, Bangladesh Health Professions Institute |
| Affiliation |
Bangladesh Health Professions Instritude |
| Address |
CRP, savar, dhaka, Bangladesh
speech and language therapy department, chapain, Savar, Dhaka, bangladesh
1343
Other |
| Phone |
01718416292 |
| Fax |
|
| Email |
nipaslt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nure Naznin Nipa |
| Designation |
Assistant Professor, Bangladesh Health Professions Institute |
| Affiliation |
Bangladesh Health Professions Instritude |
| Address |
CRP, savar, dhaka, Bangladesh
speech and language therapy department, chapain, Savar, Dhaka, bangladesh
1343
Other |
| Phone |
01718416292 |
| Fax |
|
| Email |
nipaslt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangladesh health professions instritude |
|
|
Primary Sponsor
|
| Name |
Maria Akter Ritu |
| Address |
Shariyatpur, Noria , Puran dinar hut |
| 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 Nure Naznin Nipa |
Centre for the rehabilitation of the paralyzed (CRP) ,savar, dhaka, bangladesh |
speech and language therapy department
|
01718416292
nipaslt@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: S129||Fracture of neck, unspecified, |
|
|
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 CSCI patient in voice quality |
patient will receive 12 days treatment |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Male |
| Details |
patient with cervical spinal cord injury with voice difficulties |
|
| ExclusionCriteria |
| Details |
patient with other type of spinal cord injury |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
respiratory support, resonance, loudness, dysphonia, poor phonation
|
2 weeks treatment session |
|
|
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="12"
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)
|
30/12/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/12/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
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 CSCI 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. |