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CTRI Number  CTRI/2024/04/066166 [Registered on: 23/04/2024] Trial Registered Prospectively
Last Modified On: 19/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding the experience of the caregivers of a service delivery that is based on the family centred approach for their children with cerebral palsy through an interview. 
Scientific Title of Study   Exploration of caregivers experience on family-centred care interventions for children with cerebral palsy- A qualitative study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Miss Jeevitha Rajanna 
Designation  Postgraduate Student  
Affiliation  Manipal College of Health Professions 
Address  Room No 215, 2nd floor, Department of physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9945766436  
Fax    
Email  jeevitha.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Mrs Deepalaxmi Poojary 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions 
Address  Room No 215, 2nd floor, Department of physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8971188465  
Fax    
Email  deepa.poojary@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Selvam Ramachandran 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions 
Address  Room No 215, 2nd floor, Department of physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9686738297  
Fax    
Email  selvam.ram@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital, Manipal 
 
Primary Sponsor  
Name  Jeevitha Rajanna 
Address  Department of physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India- 576104 
Type of Sponsor  Other [Self- sponsored] 
 
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 
Dr Selvam Ramachandran  Kasturba Hospital, Manipal  Room no 103, Physiotherapy opd, 1st floor, Baliga Block, Kasturba Hospital, Madhav Nagar, Eshwarnagar, Manipal- 576104
Udupi
KARNATAKA 		 9686738297

selvam.ram@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Caregivers of children with cerebral palsy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Primary caregivers of the children with cerebral palsy who can understand Kannada, with the age of the child being 4-12 years who have undergone family-centred care intervention.
 
 
ExclusionCriteria 
Details  Primary caregivers of children with cerebral palsy who have been diagnosed with psychiatric illness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to understand the experiences of caregivers of children with cerebral palsy on family-centred care interventions  An interview will be conducted six months following the implementation of family-centered care interventions 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="14" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/05/2024 
Date of Study Completion (India) 10/02/2025 
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)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Aim of the study is to explore the experiences of the caregivers of children with cerebral palsy on family-centred care interventions. The participants will be recruited from the physiotherapy OPD who visits for follow up on self-referral basis and whose children have received family-centred care interventions. A semi-structured interview guide which is content validated will be used for interviewing the participants after seeking their approval. Face-to face interview will be conducted in the physiotherapy OPD ensuring privacy throughout and audio recording will be taken upon informed consent. Data collection will be continued until no new information emerges and when the thematic data saturation is attained. Final interpretation of qualitative findings will be performed based on the available data. Thus, obtained information will be used to interpret the experiences of the caregivers on family-centred care interventions. 
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