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CTRI Number  CTRI/2024/03/063538 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 02/03/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Providing Family Centered Care by addressing the needs which are not met,of families of children with cerebral palsy 
Scientific Title of Study   Addressing Unmet Family Needs of Children with Cerebral Palsy for Family Centered Care 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priya Chitre 
Designation  Professor 
Affiliation  MAEERs Physiotherapy College 
Address  Room A-219, Department of Neuro physiotherapy, 2nd Floor OPD Complex, BSTR Hospital Building, MIMER Medical College campus, Talegaon Dabhade, Pune 410507
Department of Neuro Physiotherapy, 2nd Floor OPD Complex, BSTR Hospital Building, MIMER Medical College campus, Talegaon Dabhade, Pune 410507
Pune
MAHARASHTRA
410507
India 
Phone  7774030369  
Fax    
Email  priyachitre@mitmimer.com  
 
Details of Contact Person
Scientific Query  
Name  Priya Chitre 
Designation  Professor 
Affiliation  MAEERs Physiotherapy College 
Address  Room no A-219, Department of Neuro Physiotherapy,2nd Floor OPD Complex, BSTR Hospital Building, MIMER Medical College campus, Talegaon Dabhade, Pune 410507
Department of Neuro Physiotherapy,2nd Floor OPD Complex, BSTR Hospital Building, MIMER Medical College campus, Talegaon Dabhade, Pune 410507
Pune
MAHARASHTRA
410507
India 
Phone  7774030369  
Fax    
Email  priyachitre@mitmimer.com  
 
Details of Contact Person
Public Query  
Name  Priya Chitre 
Designation  Professor 
Affiliation  MAEERs Physiotherapy College 
Address  Room no A-219, Department of Neuro Physiotherapy,2nd Floor OPD Complex, BSTR Hospital Building, MIMER Medical College campus, Talegaon Dabhade, Pune 410507
Department of Neuro Physiotherapy, 2nd Floor OPD Complex, BSTR Hospital Building, MIMER Medical College campus, Talegaon Dabhade, Pune 410507
Pune
MAHARASHTRA
410507
India 
Phone  7774030369  
Fax    
Email  priyachitre@mitmimer.com  
 
Source of Monetary or Material Support  
D Y Patil School of Physiotherapy, Navi Mumbai 
MAEERs Physiotherapy College, Talegaon Dabhade  
 
Primary Sponsor  
Name  Priya Chitre 
Address  MAEERs Physiotherapy College, 2nd Floor OPD complex, BSTR Hospital, MIMER Medical College Campus, Talegaon Dabhade, Pune 410507 
Type of Sponsor  Other [Principal Investigator] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Priya Chitre  D Y Patil School of Physiotherapy  OPD no 26, Department of Physiotherapy, D Y Patil Hospital and Research Centre, Sri Chandrasekarendra Saraswati Vidyapuram, Plot 1-E, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Mumbai, Navi Mumbai, Maharashtra 400706
Mumbai
MAHARASHTRA 		 7774030369

priyachitre@mitmimer.com 
Priya Chitre  MAEERs Physiotherapy College  Room A-230, Neuro physiotherapy OPD, 2nd floor OPD complex, Bhausaheb Sardesai Talegaon Rural Hospital, Talegaon Dabhade, Pune 410507
Pune
MAHARASHTRA 		 7774030369

priyachitre@mitmimer.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee for Biomedical and Health Research (IECBH)  Approved 
MAEERs Physiotherapy College Ethics Committee (Biomedical & Health Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Primary 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  55.00 Year(s)
Gender  Both 
Details  Parents/caregiver(Aged more than 18 years) of children with cerebral palsy (aged from 0 to 21 years) 
 
ExclusionCriteria 
Details  Caregivers of Cerebral Palsy children having other severe comorbidities affecting Quality of Life such as Cystic Fibrosis, Malignancies, Autism Spectrum disorder,
Caregiver or immediate family of child having a disease affecting the family needs or quality of life, Non use of rehabilitation services in the past 1 year 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Frequency of Unmet Family Needs from Domains of Family Centered Care   Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Frequency of Unmet Family Needs from Domains of Family Centered Care  6 months after Baseline 
 
Target Sample Size   Total Sample Size="55"
Sample Size from India="55" 
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)   10/03/2024 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Primary Research Question :  What can be done to effectively deliver family centered care addressing the unmet Family needs in caregivers of children with cerebral palsy? Do we have an India Specific assessment for the same?

Aims:
Phase 1: Aim: To identify unmet family needs of children with cerebral palsy from domains of family centered care using focus group discussions  
Phase 2: Aim: To draft, validate and translate an India Specific Family Needs Questionnaire assessing unmet needs from domains of family centered care. (Using information received from focus group discussions, review of literature and expert opinion)
Phase 3: Aim: To design, implement and assess a service delivery targeted to addressing the unmet needs of families of children with cerebral palsy from domains of family centered care

Methodology:
Phase 1: Qualitative Cross sectional -  Focus group discussions until Data Saturation, Thematic Analysis to identify themes for needs of families of children with cerebral palsy from domains of family centered care.
Phase 2: Qualitative Cross Sectional-  Item and Domain Generation, Analysis, Item Formatting from data of Focus Group Discussions, Review of Literature and Expert opinion- Drafting of Questionnaire , Validation through Delphi Process; Translation using Beaton Guidelines.
Phase 3 : Cross Sectional: Identifying Unmet Family Needs in Objective Manner using Questionnaire, Designing a service delivery addressing the unmet needs from domains of family centered care in families of children with cerebral palsy, implementing the service delivery and assessing its efficacy by re administering the questionnaire. ( E.G The Service delivery could include addressing needs for information, needs for caregiver support through support groups, need for communication, need for co-ordinated care etc)
 
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