| 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
|
|
|
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
|
|
|
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 |