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CTRI Number  CTRI/2023/05/052522 [Registered on: 11/05/2023] Trial Registered Prospectively
Last Modified On: 04/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Normal values and Credibility of reaching test in different directions in Children  
Scientific Title of Study   Normative Scores, Validity and Reliability of Multi-directional Reach Test in Children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U918580883100  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kavita Sharma 
Designation  Ph.D. Scholar 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar University, Mullana, Ambala

Ambala
HARYANA
133207
India 
Phone  8580883100  
Fax    
Email  kavitagoel.bcip@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Aksh Chahal 
Designation  Professor 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar University, Mullana, Ambala

Ambala
HARYANA
133207
India 
Phone  9711774174  
Fax    
Email  drakshchahal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aksh Chahal 
Designation  Professor 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar University, Mullana, Ambala

Bhiwani
HARYANA
133207
India 
Phone  9711774174  
Fax    
Email  drakshchahal@gmail.com  
 
Source of Monetary or Material Support  
Toppers Institute of Maths, Science and Accountancy 
 
Primary Sponsor  
Name  Kavita Sharma 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar University, Mullana, Ambala 
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 
Aman Kanda  Toppers Institute of Maths, Science and Accountancy  Room. No. 204, Toppers Institute of Maths, Science and Accountancy
North East
DELHI 		 9818968927

dramantoppers@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethical Committee, M.M.Institute of Medical Sciences and Research, Mullana(Ambala)  Approved 
toppers school of math science and accounts studies  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Screening intervention 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  1. Children with Typical Development
2. Co-operative children
3. Functionally independent children
4. Aged between 5to 17 years
 
 
ExclusionCriteria 
Details  1. Children with visual impairment
2. Children with vestibular impairment
3. Children with hyper-mobility or hypo- mobility
4. Children with history of upper or lower limb soft tissue injuries (<1year).
5. Children with flat foot, supinated or pronated foot or other foot deformities
6. Children with limb length discrepancy
7. Children with psycho-social disorder
8. Children with neurological disorders
9. Children with cognitive impairment
10. Other medical condition

 
 
Method of Generating Random Sequence    
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Multi-directional Reach Test distance in cm  Three Reading to analyze mean 
 
Secondary Outcome  
Outcome  TimePoints 
Concurrent Validity and Intra-rater Reliability  Second Reading will be taken after 24 hours 
 
Target Sample Size   Total Sample Size="1600"
Sample Size from India="1600" 
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)   04/06/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

STUDY DESIGN: A cross sectional study.

OBJECTIVE OF THE STUDY:  The proposed study shall develop normative scores, validity and reliability of MDRT in children

NEED OF THE STUDY:

•      MDRT is a clinical instrument which lacks normative reference values for children

•      MDRT can be used to measure balance in different directions.

•      Validity and Reliability of MDRT has not been established.

•       This study will help in exploring normal ranges of reach along with critical value to enable identifying children at risk of fall at their early stages of development.

CLINICAL SIGNIFICANCE: As this clinical toolhas been proven to be advantageous in the evaluation of balance for elderly, child can easily be screened for balance impairment using this test. This test can easily be administered at any setting where sophisticated or highly technical instruments cannot be used.

STUDY SETTING: Subjects will be taken from geographical area in Haryana, Himachal Pradesh, Delhi and Uttar Pradesh.

STUDY LOCATION: Schools

STUDY DURATION: Study will be undertaken for two years

SAMPLE SIZE: Calculated using following formula

                                n = (Zασ/d)2

SAMPLING TECHNIQUE: Cluster sampling

SUBJECTS SELECTION CRITERIA:

Inclusion criteria

1.      Children with TD

2.      Co-operative children

3.      Functionally independent children

4.      Aged between 5to 17 years

 

   Exclusion criteria

1.      Children with visual impairment

2.      Children with vestibular impairment

3.      Children with  hyper-mobility or hypo-mobility

4.      Children with history of upper or lower limb soft tissue injuries (<1year).

5.      Children with flat foot, supinated or pronated foot or other foot deformities

6.      Children with limb length discrepancy

7.      Children with psycho-social disorder

8.      Children with neurological disorders

9.      Children with cognitive impairment

10.  Other medical condition

 

CONCEPT: MDRT

OPERATION: Balance assessment

MATERIALS USED FOR ASSESSMENT:

•      Three adjustable wooden stands

•      2 Rulers (each 60 cm in length)

•      Measuring tape

•      Calibrated Weighing Machine

•      Other necessary stationary

 OUTCOME MEASURE: Distance in cm

 

 
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