| CTRI Number |
CTRI/2019/12/022234 [Registered on: 03/12/2019] Trial Registered Prospectively |
| Last Modified On: |
02/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect Of Neurobics In Children |
|
Scientific Title of Study
|
Effect Of Neurobics On Anxiety And Academic Performance In Children. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sowmya Brundavanam |
| Designation |
Post graduate Student |
| Affiliation |
Alvas College of Physiotherapy |
| Address |
Alvas college of Physiotherapy
Moodibidri ,Mangalore taluk ,D.K district , Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8451921031 |
| Fax |
|
| Email |
b.sowmya.2891@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Watson Arul Singh |
| Designation |
Professor |
| Affiliation |
Alvas College of Physiotherapy |
| Address |
Alvas college of Physiotherapy
Moodibidri ,Mangalore taluk ,D.K district , Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9945892843 |
| Fax |
|
| Email |
watsonarulsingh@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Sowmya Brundavanam |
| Designation |
Student |
| Affiliation |
Alvas College of Physiotherapy |
| Address |
Plot no.21,F-3,1st.floor , shanthi paradise malleswari nagar 1st street, Madambakkam
Chennai
TAMIL NADU
600126
India |
| Phone |
8451921031 |
| Fax |
|
| Email |
b.sowmya.2891@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sowmya Brundavanam |
| Address |
Plot no.21,F-3,1st.floor , shanthi paradise malleswari nagar 1st street, Madambakkam,Chennai-600126 |
| 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 |
| Watson Arul singh |
Alvas English medium school |
Alvas college of Physiotherapy
Moodibidri ,Mangalore taluk ,D.K district , Karnataka
Dakshina Kannada
KARNATAKA |
9945892843
watsonarulsingh@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Alvas college of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No predisposing conditions. Normal school children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Controlled group |
Same as above expect there will be no usage of 2 sensations |
| Intervention |
Intervention Group |
Combination of 2 sensations and using three subjects i.e English, Maths and Science various tasks are given to the children and timed accordingly |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
1. Academic anxiety score of 3.0 -5.0 on west side anxiety scale .
2. Cooperative .
3. Right handedness.
4. Able to follow commands and understand tasks given by the therapist .
5. English medium ,7th -8th std students (male and female ). |
|
| ExclusionCriteria |
| Details |
1.No history of any psychological aliments, seizures, allergies, learning disabilities, balance and coordination disorders(Data collected from parents and teachers).
2. No active involvement or training in martial arts.
3. No external aids such as hearing aids ,orthosis ,splints which may hinder or harm them from performing the tasks
4. No physical disabilities. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| West side anxiety scale |
first is at start of the program and second is post 4 weeks but within a week post 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Successive unit tests |
Academic unit test marks for -English,Maths ,Science |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
20/12/2019 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is designed to compare the anxiety levels pre and post with the help intervention of combination sensations in a novel way that stimulates the child to use brain connections the effect of which is studied using three subjects i.e English ,maths and science and the academic performance tested using anxiety scale and marks as outcome measures |