| CTRI Number |
CTRI/2023/04/052153 [Registered on: 28/04/2023] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Balance, function and wellbeing of children during discharge from pediatric intensive care unit |
|
Scientific Title of Study
|
Profile of balance, functional status and quality of life of children in pediatric intensive care unit at the time of discharge |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poojaben Jaydipkumar Shah |
| Designation |
Post graduate student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal Hospital, Bengaluru.
Bangalore
KARNATAKA
560017
India |
| Phone |
9737314349 |
| Fax |
|
| Email |
poojaben.mhsblr2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratiksha T Rao |
| Designation |
MPT (Neurosciences), Ph.D., Associate Professor |
| Affiliation |
Manipal Academy oh Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal Hospital, Bengaluru.
Bangalore
KARNATAKA
560017
India |
| Phone |
9538124416 |
| Fax |
|
| Email |
pratiksha.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratiksha T Rao |
| Designation |
MPT (Neurosciences), Ph.D., Associate Professor |
| Affiliation |
Manipal Academy oh Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal Hospital, Bengaluru.
Bangalore
KARNATAKA
560017
India |
| Phone |
9538124416 |
| Fax |
|
| Email |
pratiksha.rao@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal College Of Health Professions |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Bengaluru |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Poojaben Shah |
Manipal Hospital |
9th floor, B side, Pediatric intensive care unit, Manipal Hospital, HAL, Bengaluru, Karnataka 560017
Bangalore
KARNATAKA |
9737314349
poojaben.mhsblr2022@learner.manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics committee of Manipal Hospitals, Bangalore |
Approved |
| Institutional Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, (2) ICD-10 Condition: G00-G99||Diseases of the nervous system, (3) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (4) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (5) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (6) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, (7) ICD-10 Condition: Q00-Q99||Congenital malformations, deformations and chromosomal abnormalities, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
PICU stay more than 72hrs.
Children who are able to follow commands
Children who are cooperative |
|
| ExclusionCriteria |
| Details |
Parents who are not willing to provide consent to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pediatric balance scale
Functional independence of measure for children/ Functional independence of measure
Pediatric quality of life inventory 4.0 generic scale |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Manual muscle testing |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "43"
Final Enrollment numbers achieved (India)="43" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2023 |
| Date of Study Completion (India) |
27/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The paediatric intensive care unit (PICU) is an integral part of the hospital where critically ill patients who require advanced airway, respiratory, and hemodynamic support are usually admitted to having a better prognosis. In this study, we will assess the profile of balance, functional status and quality of life of the children admitted to PICU at the time of discharge. With the help of the study, we can understand the abilities of children in the PICU based on the domains of activity and participation at the time of discharge which will aid in planning rehabilitation programs for these children. |