CTRI

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CTRI Number

CTRI/2025/07/090032 [Registered on: 02/07/2025] Trial Registered Prospectively

Last Modified On:

25/06/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Other (Specify) [Occupational Therapy]

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Effectiveness of reflex based therapy on activities of daily living among ADHD children

Scientific Title of Study

Effectiveness of Masgutova Neurosensorimotor Reflex Integration (MNRI) Program on Occupational Performance among Children with Attention Deficit Hyperactivity Disorder (ADHD)

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Vrindha J Shah
Designation	Pg Student
Affiliation	Chettinad School of Occupational Therapy, Kelambakkam
Address	OT- Pediatric Division,Ward No: 24, Department of Occupational Therapy,Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam. Chennai TAMIL NADU 603103 India
Phone	7305116723
Fax
Email	vrindhajshah2001@gmail.com

Details of Contact Person
Scientific Query

Name	Dr. Bhuvaneshwari S
Designation	Assistance professor
Affiliation	Chettinad School of Occupational Therapy, Kelambakkam
Address	OT- Pediatric Division,Ward No: 24, Department of Occupational Therapy,Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam. Chennai TAMIL NADU 603103 India
Phone	9840016032
Fax
Email	bhuvaneshwaris@care.edu.in

Details of Contact Person
Public Query

Name	Vrindha J Shah
Designation	Pg Student
Affiliation	Chettinad School of Occupational Therapy, Kelambakkam
Address	OT- Pediatric Division,Ward No: 24, Department of Occupational Therapy,Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam. Chennai TAMIL NADU 603103 India
Phone	7305116723
Fax
Email	vrindhajshah2001@gmail.com

Source of Monetary or Material Support

Ward No: 24, 4th Floor,Department of Occupational Therapy,Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam, TN 603103, India.

Primary Sponsor

Name	Vrindha J Shah
Address	Chettinad Academy of Research and Education Chettinad Health City Rajiv Gandhi Salai (OMR) Kelambakkam TN 603103
Type of Sponsor	Other [Self ]

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 Bhuvaneshwari S	Chettinad General Hospital	OT-Pediatric Division, Ward No: 24,Department of Occupational Therapy, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam. Chennai TAMIL NADU	9840016032 bhuvaneshwaris@care.edu.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Human Ethics Committee for Student Research ( CARE IHEC - I)	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: F01-F99\|\|Mental, Behavioral and Neurodevelopmental disorders,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Masgutova Neurosensorimotor Reflex Integration (MNRI) Program	The Masgutova Neurosensorimotor Reflex Integration (MNRI) Program will be conducted over a period of 8 weeks, with each session lasting 45 minutes, three days per week.
Comparator Agent	Not Applicable	Not Applicable

Inclusion Criteria

Age From	7.00 Year(s)
Age To	12.00 Year(s)
Gender	Both
Details	- Children diagnosed with ADHD based on Vanderbilt ADHD diagnostic parent rating scale (VADPRS) - Age between 7-12 years old - Positive ATNR with a score of at least 1 using - Schilder Test - Receiving Occupational Therapy services - No history of MNRI protocol use for ATNR reflex

ExclusionCriteria

Details

- Other diagnoses or co-existing diagnoses with ADHD
- Age above 7 years or below 12 years of age
- Negative ATNR with a score of 0 using Schilder Test
- History of MNRI protocol used to integrate ATNR

Method of Generating Random Sequence

Permuted block randomization, fixed

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
- Schilder Test - Canadian Occupational Performance Measure(COPM)	Each session 45 minutes, 3 days per week, for 8 weeks.

Secondary Outcome

Outcome	TimePoints
Not Applicable	Not Applicable

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
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)

01/09/2025

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="2"
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

This study is a randomized, parallel-group, active-controlled trial evaluating the effectiveness of the Masgutova Neurosensorimotor Reflex Integration (MNRI) program on occupational performance in children with Attention Deficit Hyperactivity Disorder (ADHD).
The intervention will be conducted over a period of eight weeks at Chettinad Health City Hospital in India. The primary outcome measures are the Schilder Test and the Canadian Occupational Performance Measure (COPM), both assessed over a two-month period.