CTRI Number |
CTRI/2023/04/051332 [Registered on: 06/04/2023] Trial Registered Prospectively |
Last Modified On: |
16/04/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
The Relationship Between How Strongly Children Can Hold Things and How Well They Can Breathe In, for Kids Who Were Born Early and are Now in School. |
Scientific Title of Study
|
Correlation Of Grip Strength And Inspiratory Pressure In Preterm School Going Children |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Shukra Chivate |
Designation |
Assistant Professor |
Affiliation |
KLE Academy of Higher Education and Research Institute of Physiotherapy |
Address |
KLE Academy of Higher Education and Research Institute of Physiotherapy
Nehru Nagar Belgaum
Karnataka India KLE Academy of Higher Education and Research Institute of Physiotherapy
Nehru Nagar Belgaum
Karnataka India Belgaum KARNATAKA 590010 India |
Phone |
8494869446 |
Fax |
|
Email |
shukrachivate@klekipt.edu.in |
|
Details of Contact Person Scientific Query
|
Name |
Snehal Thaleshwar |
Designation |
PG Student |
Affiliation |
KAHER Institute Of Physiotherapy , Belgaum |
Address |
KLE Academy of Higher Education and Research Institute of Physiotherapy
Nehru Nagar Belgaum
Karnataka India KLE Academy of Higher Education and Research Institute of Physiotherapy
Nehru Nagar Belgaum
Karnataka India Belgaum KARNATAKA 590010 India |
Phone |
9730488516 |
Fax |
|
Email |
snehalthaleshwar1998@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Snehal Thaleshwar |
Designation |
PG Student |
Affiliation |
KAHER Institute Of Physiotherapy , Belgaum |
Address |
KLE Academy of Higher Education and Research Institute of Physiotherapy
Nehru Nagar Belgaum
Karnataka India KLE Academy of Higher Education and Research Institute of Physiotherapy
Nehru Nagar Belgaum
Karnataka India Belgaum KARNATAKA 590010 India |
Phone |
9730488516 |
Fax |
|
Email |
snehalthaleshwar1998@gmail.com |
|
Source of Monetary or Material Support
|
KLE Dr.Prabhakar KoreS Hospital and MRC |
|
Primary Sponsor
|
Name |
Snehal thaleshwar |
Address |
189 plot no
shivbasava nagar
belagavi 590010 |
Type of Sponsor |
Other [[self-sponsored ]] |
|
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 |
snehal thaleshwar |
KLE Dr. Prabhakar Kores Hospital and MRC |
JNMC Campus , Nehru nagar Belgavi-590010 Belgaum KARNATAKA |
9730488516
snehalthaleshwar1998@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Research ad ethics Committee of KAHER Institute of Physiotherapy |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
preterm school going children
|
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
8.00 Year(s) |
Age To |
12.00 Year(s) |
Gender |
Both |
Details |
Children born less than 37weeks of gestational age for preterm group, Children who were hospitalized after birth,Both genders between 8-12 years of age, Children whose parents allow them to participate in the study ,Preterm-born children going to normal private school |
|
ExclusionCriteria |
Details |
Hearing and visual impairment. , Medically diagnosed Neurological conditions such as cerebral palsy, physical disabilities, or medical/physical deteriorating conditions., Musculoskeletal problems like fractures, any surgeries, pain, or trauma in the past 3 months , Any Congenital deformities, Diagnosed cardiorespiratory conditions |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Other |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
-grip strength -Jamar Dynamometer
-maximum inspiratory pressure-u-tube Manometer |
-grip strength -baseline
maximum inspiratory pressure - baseline |
|
Secondary Outcome
|
Outcome |
TimePoints |
nil |
nil |
|
Target Sample Size
|
Total Sample Size="52" Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
07/04/2023 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
non yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Every year, approximately 1.5 million babies are born preterm (i.e., before 37 completed weeks of gestation), and this number is increasing day by day. The effect of preterm birth amongst some survivors may continue throughout life, impairing motor functioning and affecting long-term physical health which also includes lung functions and capacities in the later stages of life. Preterm birth can be subdivided based on gestational age: extremely preterm (<28 weeks), very preterm (28 - <32 weeks), moderate preterm (32 - <34weeks), and late preterm birth (34 - <37 completed weeks). There is a greater majority that preterm are born 32-36 weeks. The incidence of preterm born in Belagavi is 8.6 %. Preschool children who are born preterm have various motor difficulties and challenges compared to term-born children and are poorer in the motor examinations. Grip weakness is linked to a number of poor health outcomes in later life , such as cardiovascular disease and functional disability. Regardless of whether the preterm birth need neonatal critical care, the survivors in children exhibit worsened respiratory symptoms. Grip strength is a helpful measurement that can be utilized as a general indication of strength and health outcomes in adults. To reduce the possibly confounding effect of lower coordination, which is more likely to affect preterm infants, we used grip strength as a measure of strength rather than a more functional strength (e.g., standing long jump). Inspiratory pressure is a negative pressure the patient is able to generate when inhalation is done. It suggests muscle strength and ventilatory reserve. Maximum inspiratory pressure is one of the common ways the assess the strength of the inspiratory muscles. This pressure is also considered as equal to the strength of the peripheral muscles. The current study will be done to determine the correlation of grip strength and inspiratory pressure in preterm. It may also serve as a reference study performed in the ICU. |