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CTRI Number  CTRI/2019/08/020527 [Registered on: 02/08/2019] Trial Registered Prospectively
Last Modified On: 01/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Family centered care in Cerebral Palsy 
Scientific Title of Study   The Effectiveness of Family Centered Approach through Capacity Building of caregivers of children with Cerebral Palsy on their Quality of Life and Family Empowerment 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepalaxmi Paresh Poojari 
Designation  Assistant Professor 
Affiliation  Manipal College Of Health Professions 
Address  Department of Physiotherapy Manipal College of Health Professions MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  deepa.poojary@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  DR Shashikiran U 
Designation  Head of the Department 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Medicine Dr TMA Pai Hospital Udupi

Udupi
KARNATAKA
576104
India 
Phone  9008418171  
Fax    
Email  shashikiran.u@manipal.edu  
 
Details of Contact Person
Public Query  
Name  DR Shashikiran U 
Designation  Head of the Department 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Medicine Dr TMA Pai Hospital Udupi

Udupi
KARNATAKA
576104
India 
Phone  9008418171  
Fax    
Email  shashikiran.u@manipal.edu  
 
Source of Monetary or Material Support  
Deepalaxmi Paresh Poojari, Dept of Physiotherapy, Manipal College of Health Science, MAHE,Manipal 
 
Primary Sponsor  
Name  Deepalaxmi Paresh Poojari Principle investigator 
Address  Dept of Physiotherapy, MCHP, Manipal Academy of Higher Education,Manipal 
Type of Sponsor  Other [SELF] 
 
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 
Mrs Deepalaxmi Paresh Poojari  Kasturba Hospital,Manipal  Department of Physiotherapy(Paediatric and Womens health) ,Room number103,Kasturba Hospital, Manipal
Udupi
KARNATAKA 		 8971188465

deepa.poojary@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  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Care givers of children with cerebral palsy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Family centered care  Family Centered Care in caregivers of children with Cerebral Palsy along with standard care for 12 weeks and will be followed upto 24th week. At the end of 12th and 24th week reassessment will be done 
Comparator Agent  Standard care  Standard care as advised by the clinician and/or by the physiotherapist throughout 24 weeks 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  For child
Diagnosed cases of cerebral palsy by a Clinician and/ or Physiotherapist
Age 4- 12 years
For caregiver
Primary caregiver of children with cerebral palsy with the ability to read and write in Kannada or English
For mentor
Anganwadi workers/Peer mentor/ASHA mentors
Knowledge about the various government and non- government services and facilities and its access to the community
Good language skills
 
 
ExclusionCriteria 
Details  For child
Any systemic illness impending their participation in the intervention
For caregiver
Any physical disability or diagnosed major psychiatry illness impending their participation
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Quality of Life of caregivers using WHOQLBref
Empowerment of caregivers using the Family Empowerment Scale(FES)
Measures of Process of Care (MPOC-20)
 		 3point of time
0 week
12 week
24 week
 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of Life of children using the Cerebral Palsy Quality of Life Quesionnaire (CPQOL
Activity and Participation in children using Child & Adolescent Scale of Participation
(CASP)

 		 3 point of time
0 week
12 week
24 week 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "76"
Final Enrollment numbers achieved (India)="76" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   02/08/2019 
Date of Study Completion (India) 17/08/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 17/08/2024 
Estimated Duration of Trial   Years="4"
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)?  

Brief Summary   This  study is a 24 week 3 arm cluster randomised controlled trial to study the effectiveness of capacity building of caregivers of children with cerebral palsy through a family centered approach. The primary outcome measure will be assessing family empowerment using Family Empowerment Scale and quality of life of caregivers using WHO QOL BREF at 0,12 and 24th week. The secondary outcome will be assessing the  child’s activity and participation using CASP and quality of life of child by using CPQOL at 0,12 and 24 week.  
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