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CTRI Number  CTRI/2019/03/018316 [Registered on: 29/03/2019] Trial Registered Prospectively
Last Modified On: 28/03/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   comparison of visual and goniometric assessment and inter observer difference in assessing Amiel tison angles in high risk infants  
Scientific Title of Study   Comparison of visual and goniometric assessment and analysis of inter observer difference in assessing Amiel Tison angles in high risk infants  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KPRupasree 
Designation  MPT neuroscience 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  28-417, Sri krishna Dewaraya street, arcot building, Ramnagar colony, Chittoor
28-417, Sri krishna Dewaraya street, Arcot building, Ramnagar colony, Chittoor
Chittoor
ANDHRA PRADESH
517001
India 
Phone    
Fax    
Email  rupasree1995@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mrs M Rajeswari 
Designation  Assistant professor  
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute of Higher Education and Research Institute Porur Chennai
Sri Ramachandra Institute of Higher Education and Research Institute Porur Chennai
Kancheepuram
TAMIL NADU
600116
India 
Phone  9841417473  
Fax    
Email  rajeswarim2001@gmail.com  
 
Details of Contact Person
Public Query
 
Name  K P Rupasree 
Designation  Post Graduate Student 
Affiliation  K.P Rupasree 
Address  28-417, Sri Krishna Dewaraya Street, Arcot Building, Ramnagar Colony, Chittoor
45 4rth Cross Street Pg avenue Kattuppakam Chennai
Chennai
TAMIL NADU
K P Rupasree
India 
Phone  8870042592  
Fax  -  
Email  rupasree1995@gmail.com  
 
Source of Monetary or Material Support  
Rupasree(self) 
 
Primary Sponsor  
Name  Rupasree Self Funding 
Address  Sri Ramachandra Institute Of Higher Education and Research Institute 
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 
KPRupasree  Sri Ramachandra Higher Education and Research Institute  Pediatric department , Karthikeyan child development unit(kcdu)room no : 16, Porur Chennai
Chennai
TAMIL NADU 
8870042592
-
rupasree1995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee approval for students projects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  8.00 Month(s)
Gender  Both 
Details  High Risk Infants at 8 months
 
 
ExclusionCriteria 
Details  Infants with Musculoskeletal Impairments
Chromosomal Abnormalities 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
360 degree plastic Goniometer  10 - 15 minutes  
 
Secondary Outcome  
Outcome  TimePoints 
Visual assessment  2weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   15/04/2019 
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="19"
Months="4"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Infants who are born with biologic or environmental risk factors that might contribute to later developmental delay or deficits are termed as high risk infants. High risk factors include preterm birth with GA ≤ 32 weeks, Low birth weight ≤ 1500gms, Neonatal Convulsions, Respiratory Distress Syndrome, Broncho pulmonary Dysfunction, Apnoea of Prematurity, Haemorrhage, Hypoglycemia, Neonatal hyperbilirubinaemia, Neonatal infections. Most common causes of death for infants aged 0-4 weeks were low birth weight, asphyxia and sepsis, while for infants aged 1-11 months, it was pneumonia. Advances in perinatal intensive care have been associated with improved survival of high-risk neonates but have not resulted in decreased morbidity
High risk infants are at risk of developing neurological problems either because of adverse environmental factors, lack of developmental supportive care, poor nutrition, or various health factors. Developmental delay is diagnosed when a child does not reach a developmental milestone All infants at high risk of developmental delay and require periodic developmental assessment at first year of life to prevent and identify the neuromotor deficit at an early age. Amieltison method is commonly used technique for assessing neurological status of infants and Muscle tone is an important component of Neuromotor assessment which would be deviated even with subtle neural impairment which need to be assessed and intervened.
Clinically visual method is widely being followed in assessing Amiel tison angles in the first year of life in high risk infants but visual assessment may not be reliable and visual perception can be different with two observers which could change the interpretation of muscle tone. This study intends to compare the Visual and goniometric assessment and inter observer difference in the assessment of Amieltison angles.

 
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