| CTRI Number |
CTRI/2023/06/053810 [Registered on: 13/06/2023] Trial Registered Prospectively |
| Last Modified On: |
09/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
To check the effectivess in brain gym exercises with movement based learning on mental health,stability and physical ability in school going children with learning disability |
|
Scientific Title of Study
|
Comparison of Brain Gym Exercise versus Movement Based Learning on Cognitive,Balance & Physical performance on school going children with Learning disability. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zara Abir Sabir |
| Designation |
Master of Physiotherapy student |
| Affiliation |
MGM UNIVERSITY OF HEALTH SCIENCES,NAVI MUMBAI |
| Address |
2nd floor mgm school of physiotherapy c building N-6 cidco, Aurangabad
Aurangabad
MAHARASHTRA
431010 India
Kamote,Navi Mumbai,Maharashtra,India
Aurangabad
MAHARASHTRA
431010
India |
| Phone |
8767226192 |
| Fax |
|
| Email |
zarabir26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pallavi Palaskar |
| Designation |
Associate Professor |
| Affiliation |
MGM UNIVERSITY OF HEALTH SCIENCES,NAVI MUMBAI |
| Address |
2nd floor mgm school of physiotherapy c building N-6 cidco, Aurangabad
Aurangabad
MAHARASHTRA
431010 India
Kamote,Navi Mumbai,Maharashtra,India
Aurangabad
MAHARASHTRA
431010
India |
| Phone |
9604487807 |
| Fax |
|
| Email |
pallavi.palaskar@mgmsop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Pallavi Palaskar |
| Designation |
Master of Physiotherapy student |
| Affiliation |
MGM UNIVERSITY OF HEALTH SCIENCES,NAVI MUMBAI |
| Address |
2nd floor mgm school of physiotherapy c building N-6 cidco, Aurangabad
Aurangabad
MAHARASHTRA
431010 India
Kamote,Navi Mumbai,Maharashtra,India
Aurangabad
MAHARASHTRA
431010
India |
| Phone |
09604487807 |
| Fax |
|
| Email |
zarabir26@gmail.com |
|
|
Source of Monetary or Material Support
|
|
MGM SCHOOL OF PHYSIOTHERAPY,AURANGABAD |
|
|
Primary Sponsor
|
| Name |
MGM School of Physiotherapy,Aurangabad |
| Address |
2nd floor mgm school of physiotherapy c building N-6 cidco, Aurangabad
Aurangabad
MAHARASHTRA
431010 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| ZARA ABIR SABIR |
MGM SCHOOL OF PHYSIOTHERAPY |
MGM Neurophysiotherapy department/PEDIATRIC Unit/Room no 7
N-6 CIDCO,Aurangabad.
Aurangabad
MAHARASHTRA |
8767226192
zarabir26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for research on human sbjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F70||Mild intellectual disabilities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brain Gym Exercises |
3 days in a week for 45 mins for 6 weeks |
| Intervention |
Movement Based Learning |
3 times a week for 45 mins for 6 weeks |
| Comparator Agent |
Physical Exercise |
3 times a week for 45 mins for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children of both the genders aged6-8yrs with mild learning disability diagnosed by psychologist.
Children without any physical disability.
Children without any cardiovascular illness.
Children with stable cardiovascular status.
Children without any contraindications for exercise. |
|
| ExclusionCriteria |
| Details |
Children with mental retardation.
Children with major surgeriesand plastercasted limbs.
Children having difficulty in following and understanding commands. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mini Mental Scale |
Baseline and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pediatric Berg balance Scale |
Baseline and 6 weeks |
| Step Test |
Baseline and 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
26/06/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
Comparisonn of Brain Gym exercises and movement based learning on cognition,balance and physical activity in school going children with learning disability. |