CTRI

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CTRI Number

CTRI/2024/04/065965 [Registered on: 19/04/2024] Trial Registered Prospectively

Last Modified On:

18/04/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Physiotherapy (Not Including YOGA)

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

To see The Effect Of Two Different Training activities(1)related to playful activities which includes brain exercises (2)general large muscle exercises in undernourished children and how this activities effect their balance , quick movements and ability to perceive learn and recall

Scientific Title of Study

To compare the effect of neurobic training and aerobic training in cognition,single ,stance balance, and agility in undernourished children

Trial Acronym

nil

Secondary IDs if Any

Secondary ID	Identifier
nil	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Pooja Purendra Chandrakar
Designation	Research Scholar MPT
Affiliation	Manav Rachna International Institute of Research and Studies
Address	Manav Rachna International Institute of Research and Studies, Department Of Physiotherapy, Division Q block Room No.QG 07 Neurology lab ,Sector-43, Delhi-Surajkund Road Faridabad, Haryana Faridabad HARYANA 121004 India
Phone	8770160831
Fax
Email	poojachandrakar083197@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sunita Kumari
Designation	Assistant Professor
Affiliation	Manav Rachna International Institute of Research and Studies
Address	Manav Rachna International Institute of Research and Studies, Department Of Physiotherapy, Division Q block Room No.QG 07 Neurology lab ,Sector-43, Delhi-Surajkund Road Faridabad, Haryana Faridabad HARYANA 121004 India
Phone	8800125047
Fax
Email	sunita.fas@mriu.edu.in

Details of Contact Person
Public Query

Name	Dr Sunita Kumari
Designation	Assistant Professor
Affiliation	Manav Rachna International Institute of Research and Studies
Address	Manav Rachna International Institute of Research and Studies, Department Of Physiotherapy, Division Q block Room No.QG 07 Neurology lab ,Sector-43, Delhi-Surajkund Road Faridabad, Haryana Faridabad HARYANA 121004 India
Phone	8800125047
Fax
Email	sunita.fas@mriu.edu.in

Source of Monetary or Material Support

Manav Rachna International Institute of Research and Studies manav rachna campus Rd, Gadakhor Basti Village, sector 43, faridabad, haryana, pincode-121004 india

Primary Sponsor

Name	NONE
Address	NONE
Type of Sponsor	Other [NONE]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Sunita Kumari	Manav Rachna International Institute Of Research And Studies	Department of Physiotherapy Neurology physiotherapy lab Q-block room number - QG 07, MRIIRS sector 43 Aravalli Hills Surajkund road Faridabad HARYANA Faridabad HARYANA	8800125047 sunita.fas@mriu.edu.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Ethical Committee, SAHS, MRIIRS	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Undernourised Children

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Aerobic Training	Subject will be given aerobic training with music for 4 weeks ,3 days a week.
Intervention	Neurobic Training	Subject will be given neurobic training with aerobic training for 4 weeks ,3 days a week.

Inclusion Criteria

Age From	8.00 Year(s)
Age To	13.00 Year(s)
Gender	Both
Details	Undernourished children. Age 8-12years (both male and female).

ExclusionCriteria

Details

Recent injury, open wound.
Normal-weight children.
Overweight children.
Recent surgery.
Any cardiac or respiratory issues.
Any hearing or visual defect
Language barrier- inability to understand Hindi or English.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
MOCA Score Single Leg Stance Test Score T-Test Score	Base line Assessment Re-Assessment After 4 Weeks

Secondary Outcome

Outcome	TimePoints
none	none

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
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)

29/04/2024

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="3"
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 aims of the study is to compare the effect of neurobic training and aerobic training on cognition ,single stance balance, and agility in undernourished children.

Subjects will be recruited from discovery convent school faridabad. A Study sample of 30 participants will be selected on the basic of inclusion and exclusion criteria. The subjects will be randomly divided into 2 groups: Group A- Neurobic Group, Group B- Aerobic Group. A Written informed consent will be taken from the participantsâ€™s parents/guardian after explaining them the training program, associated risks and benefits. Outcome measures will be measured at baseline and after termination of 4 weeks and will be compared.