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
|
|
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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, |
|
Intervention / Comparator Agent
|
|
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 |
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Method of Generating Random Sequence
|
|
Method of Concealment
|
|
Blinding/Masking
|
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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 morbidityHigh 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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