| CTRI Number |
CTRI/2024/01/061749 [Registered on: 23/01/2024] Trial Registered Prospectively |
| Last Modified On: |
18/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Behavioural Control of the brain in children with and without Stuttering |
|
Scientific Title of Study
|
Comparison of Executive function in children with and without Childhood Onset Fluency Disorder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deborah Ann Abraham |
| Designation |
Student |
| Affiliation |
National Assessment and Accreditation Council |
| Address |
Department of Speech and Hearing
6th Floor, LH5
Manipal College of Health Profession (MCHP)
Manipal Academy of Higher Education (MAHE)
Manipal - 576104
Udupi
KARNATAKA
641008
India |
| Phone |
9159238889 |
| Fax |
|
| Email |
deborah1.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr veena KD |
| Designation |
Assistant Professor |
| Affiliation |
National Assessment and Accreditation Council |
| Address |
Department of Speech and Hearing
4th floor, room no. 405
Manipal College of Health Professions (MCHP)
Manipal Academy of Higher Education (MAHE)
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09448824346 |
| Fax |
|
| Email |
r.veena@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena KD |
| Designation |
Assistant Professor |
| Affiliation |
National Assessment and Accreditation Council |
| Address |
Department of Speech and Hearing
4th Floor,room no.405,
Manipal College of Health Professions
Manipal Academy of Higher Education (MAHE)
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09448824346 |
| Fax |
|
| Email |
r.veena@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal;
TMA Pai hospital, Udupi;
TMA Pai Hospital, Karkala |
|
|
Primary Sponsor
|
| Name |
Deborah Ann abraham |
| Address |
Department of Speech and Hearing
Manipal College of Health Professions
Manipal academy of Higher education |
| 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 |
| Dr Veena KD |
Manipal College of Health Professions |
Department of Speech and Hearing, Pre - clinical Laboratory, Room no. 416, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal - 576104
Udupi
KARNATAKA |
9448824346
r.veena@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children without stuttering |
| Patients |
(1) ICD-10 Condition: F808||Other developmental disorders of speech and language, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
2 groups: Individuals with mild to severe stuttering and normal individuals
Age range: 6-12 years
Age and Gender matched controls
Characteristics: Average to good academic proficiency and intelligence, Individuals with Speech disorders, learning disability (LD) will be included
|
|
| ExclusionCriteria |
| Details |
Individuals with co-morbidities such as language impairment, other speech impairments, cognitive impairment, hearing impairment, neurological impairment, visual impairment (ruled out by ophthalmologist), Specific Language Impairment (SLI) will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cognitive Flexibility: Reaction time
Planning: Reaction time, productivity, coherence, efficiency |
10 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare linguistic & non – linguistic abilities in cognitive flexibility & planning in childhood-onset fluency disorder (COFD) |
10 weeks |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
27/01/2024 |
| 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="7"
Days="0" |
|
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
|
The primary purpose of this study is to compare the executive function such as cognitive flexibility and planning between children with and without Childhood Onset Fluency Disorder (COFD) and the secondary purpose is to compare between linguistic and non - linguistic tasks in cognitive flexibility and planning. The study hypothesis is that executive function is slower in children with COFD than children without COFD. Need for the study: The study of executive function in stuttering has to be further explored as it helps in diving deeper into the emergence, multifactorial nature, the variability as in the different severity and the subgroups of Childhood – Onset Fluency Disorder (COFD).Therefore, it is essential to investigate the role of executive functions based on cognitive flexibility, planning and organization in COFD.
|