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CTRI Number  CTRI/2022/08/045014 [Registered on: 29/08/2022] Trial Registered Prospectively
Last Modified On: 25/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Grip strength and its impact on fine motor skills in preterm children at 3-5 years 
Scientific Title of Study   Analysis of Grip Strength in Preterm children and its Impact on Fine Motor Skills at 3-5 Years  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DEEPIKAAU 
Designation  Student 
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  Sri Ramachandra Institute Of Higher Education And Research, Porur, Chennai.
Karthikeyan child development unit Sri Ramachandra Medical center - C2 Sri Ramachandra general block- 1st floor Sri Ramachandra Institute Of Higher Education And Research, Porur, Chennai.
Chennai
TAMIL NADU
600116
India 
Phone  7010233470  
Fax    
Email  t0320010@sriramachandra.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  M Rajeswari 
Designation  Associate Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  Faculty of Physiotherapy, Sri Ramachandra Institute of Higher education and Research Porur
Sri Ramachandra Institute Of Higher Education And Research, Porur, Chennai.
Chennai
TAMIL NADU
600116
India 
Phone  9841417473  
Fax    
Email  rajeswari@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  DEEPIKA AU 
Designation  Student 
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  Faculty of Physiotherapy Sri Ramachandra Institute of Higher Education and Research Porur
Faculty of Physiotherapy Sri Ramachandra Institute of Higher Education and Research Porur
Chennai
TAMIL NADU
600116
India 
Phone  7010233470  
Fax    
Email  t0320010@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Sri Ramachandra institute of higher education and research  
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [] 
 
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 
Deepika AU  Sri Ramachandra Institute of Higher Education and Research  Karthikeyan Child Development Unit Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai
Chennai
TAMIL NADU 
7010233470

t0320010@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Preterm children of 3-5 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Preterm children of both genders under the age group from 3-5 years were included in the study 
 
ExclusionCriteria 
Details  Children with Neurological impairments, Musculoskeletal impairments of the upper limb, Congenital deformities, hearing impairments, and visual impairments were excluded from the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Peabody Developmental Motor Scale PDMS – 2:  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Martin Vigorimeter  4 weeks 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   05/09/2022 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Preterm infants are defined as those born before 37 weeks of completed pregnancy or less than 259 days; an estimated 15 million babies are born early every year.1 Approximately 1 million children die each year due to complications of preterm birth, other survivors face a lifetime of disability, including learning disabilities and visual and hearing problems.2.The extremely premature infant (less than 28 weeks gestation) and extremely low birth weight infant (ELBW) (< 1000 grams) remain at high risk for death and disability with 30–50% mortality and, in survivors, at least 20–50% risk of morbidity with delayed motor development due to impaired brain growth particularly they have white matter injury causing subtle changes in oligodendrocytes which is carried over to later years.3,4When compared with full-term infants, preterm children have the prevalence of abnormal fine motor scores which are especially crucial in 3-5 years as it helps in handwriting for academic purposes and self-care in activities of daily life.5 Delay in fine motor skills causes increased dependency on parents and caregivers.6 While the primary development of muscle tissue occurs prior to birth, differentiation of muscle fibers is considered incomplete until 40 weeks post conception.7 Preterm children have incomplete development in muscular tissue and extremity flexor tone. These immature musculoskeletal developments produce maturation-related hypotonia which contributes to the vulnerability of postural and skeletal malalignment 8which leads to reduced force production by the muscles against gravity9. Fine Motor development, does not appear as gross motor activities, it is solely by the infant’s biological maturity. Infants born at very early gestational ages exhibit significant differences in their fine motor development compared with their normal counterparts. 10Adequate muscular strength of the hands and fingers is required for effective fine motor development11. Hand function develops mainly at 3-5 years where the demand is more12.So to quantify grip strength Martin Vigorimeter is used 13 and it is correlated with fine motor skills through Peabody developmental motor scale assessment.14
 
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