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CTRI Number  CTRI/2021/07/035047 [Registered on: 22/07/2021] Trial Registered Prospectively
Last Modified On: 14/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   TONE IN NEURODEVELOPMENTAL CHILDREN 
Scientific Title of Study   TONAL PROFILE OF CHILDREN WITH NEURODEVELOPMENTAL DISORDER VISITING TERTIARY CARE HOSPITAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Koyal Shanbhag 
Designation  Post Graduate Student 
Affiliation  SDM University 
Address  SDM College of Medical Sciences and Hospital, SDM College of Physiotherapy, Manjushrinagar, Sattur, Dharwad-Karnataka.

Dharwad
KARNATAKA
580009
India 
Phone  07588883034  
Fax  08362462253  
Email  shanbhagkoyal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Koyal Shanbhag 
Designation  Post Graduate Student 
Affiliation  SDM University 
Address  SDM College of Medical Sciences and Hospital, SDM College of Physiotherapy, Manjushrinagar, Sattur, Dharwad-Karnataka.

Dharwad
KARNATAKA
580009
India 
Phone  07588883034  
Fax  08362462253  
Email  shanbhagkoyal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Parmar Sanjay Tejraj 
Designation  Vice Principal 
Affiliation  SDM University 
Address  SDM College of Medical Sciences and Hospital, SDM College of Physiotherapy, Manjushrinagar, Sattur, Dharwad-Karnataka.

Dharwad
KARNATAKA
580009
India 
Phone  9845340450  
Fax  08362462253  
Email  sanjaytparmar777@gmail.com  
 
Source of Monetary or Material Support  
SDM College of Physiotherapy Manjushree Nagar, Sattur, Dharwad 
 
Primary Sponsor  
Name  Koyal Shanbhag 
Address  SDM College of Medical Sciences and Hospital, SDM College of Physiotherapy, Manjushrinagar, Sattur, Dharwad-Karnataka. 
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 
Koyal Shanbhag  SDM College of Medical Sciences and Hospital  OPD No.13 Paediatric Physiotherapy OPD SDM Hospital, Manjushree Nagar Sattur
Dharwad
KARNATAKA 		 07588883034
08362462253
shanbhagkoyal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Permission  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F849||Pervasive developmental disorder,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Children with confirmed medical diagnosis of Neurodevelopmental disorder by the medical practitioner.
2. Age group - 4-18 years of children with either gender
3.Should have hypertonia (increased resistance to passive stretch of the muscle) in at least one limb.
4. Children those who are able to follow simple instructions (such as closing and opening the eyes) and lie in a supine position for 20 minutes
 
 
ExclusionCriteria 
Details  1. Recent Botulinum toxin therapy (less than 6 months);
2. Recent Surgical intervention of upper extremity or lower extremity.
3. Cognitive impairment
4. Children who do not allow to perform passive movements
5. Non willing parents,
6. Seizures(uncontrolled)
7. Complex communication disorders.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Hypertonia assessment Scale
 		 At Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/07/2021 
Date of Study Completion (India) 14/07/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 According to inclusion and exclusion criteria, the study subjects will be considered. The legal guardians of all children will be first informed about the research and an informed consent will be obtained from them. The research procedure will be properly explained to the parents. The demographic data will be collected from each participant. An objective tool that is the Hypertonia Assessment Tool (HAT) will be used in this study. It is used to classify the hypertonia and identify the predominant tone and classify them into spastic, dyskinetic (dystonic and choreo-athetotic), ataxic and mixed types. The evaluator moves the child’s arm or leg with purposeful stretches and movements in order to determine the tone and present them into the subtypes. HAT is a seven-item tool and is capable of discriminating hypertonia subtypes for both upper and lower extremity and it takes hardly 5 mins for each limb. Children between 4-16 years and having hypertonia i.e increased resistance to passive stretch in atleast one limb will be considered. Each limb will be separately assessed. The child will be in supine on the examination table. A roll will be placed below knees and pillow under the head before starting with the assessment. The child will be in comfortable unrestrictive clothings. Splints or socks if present would be removed and hands will be placed on abdomen if possible. 
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