| CTRI Number |
CTRI/2024/01/061456 [Registered on: 15/01/2024] Trial Registered Prospectively |
| Last Modified On: |
13/01/2024 |
| 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 effectiveness of thermal stimulation to reduce drooling among children with cerebral palsy |
|
Scientific Title of Study
|
Effectiveness of thermal stimulation to reduce drooling among children with cerebral palsy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DIPA AKTER |
| Designation |
STUDENT |
| Affiliation |
Bangladesh Health Professions Institute (BHPI), Savar, Dhaka |
| Address |
Savar,Dhaka, Bangladesh
Cumilla,Chittagong, Bangladesh
1343
Other |
| Phone |
01837117278 |
| Fax |
|
| Email |
dipaakter12793@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjida Subahan |
| Designation |
Lecturer |
| Affiliation |
Bangladesh Health Professions Institute (BHPI),Savar,Dhaka |
| Address |
Savar,Dhaka, Bangladesh
1343
Other |
| Phone |
01682990501 |
| Fax |
|
| Email |
sanjidaslt93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjida Subahan |
| Designation |
Lecturer |
| Affiliation |
Bangladesh Health Professions Institute (BHPI),Savar,Dhaka |
| Address |
Savar,Dhaka, Bangladesh
1343
Other |
| Phone |
01682990501 |
| Fax |
|
| Email |
sanjidaslt93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangladesh Health Professions Institute (BHPI),CRP |
|
|
Primary Sponsor
|
| Name |
Dipa Akter |
| Address |
Savar,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 |
Centre for the rehabilitation of the paralyzed (CRP), Savar, Dhaka, Bangladesh |
speech and language therapy department
|
01682990501
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: O00-O9A||Pregnancy, childbirth and the puerperium, (2) ICD-10 Condition: F59||Unspecified behavioral syndromes associated with physiological disturbances and physical factors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Thermal stimulation |
Patient will receive thermal stimulation for 8 days |
| Comparator Agent |
Thermal stimulation among CP children in drooling |
Patient will receive 8 days treatment |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Presence of drooling
Children whose parents are thought to be capable of adhering to the study protocol |
|
| ExclusionCriteria |
| Details |
Children using drugs or medication, other therapy that could control their saliva production or otherwise have an impact on their drooling |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Severity, Frequency, Impact of drooling |
1 month treatment session |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the severity and frequency of drooling |
240 hr |
|
|
Target Sample Size
|
Total Sample Size="15"
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)
|
25/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/01/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="10" |
|
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
|
It is a quasi-experimental study with purposive sampling will conduct at Speech & Language Therapy Department of CRP, Savar, Dhaka, Bangladesh over a period of 8 therapy session. N=15, Cerebral Palsy cases with drooling , both gender, aged 3-12 years underwent thermal stimulation for drooling control. Severity and frequency of drooling will assess on Drooling Severity & Frequency Scale and Drooling Impact Scale before intervention and post intervention at 2 occasions. Statistical analysis will be carried using SPSS Version 25. |