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CTRI Number  CTRI/2024/06/069085 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 17/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Relationship between quality of life and hand function 
Scientific Title of Study   Correlation between quality of life and hand function in children with cerebral palsy of age group 4-12 years  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Archana Gore 
Designation  Assistant Professor 
Affiliation  Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai 
Address  402, Physiotherapy School and centre,Seth G.S. Medical College and KEM Hospital, OC Building, E Borges Road ,Opposite Tata Hospital, Parel, Mumbai
Physiotherapy School and Centre, Seth G.S Medical College and KEM Hospital, Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  9082621220  
Fax    
Email  nilarch17@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Komal Dilip Gaikwad  
Designation  MPT Student  
Affiliation  Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai 
Address  402, Physiotherapy School and centre,Seth G.S. Medical College and KEM Hospital, OC Building, E Borges Road ,Opposite Tata Hospital, Parel, Mumbai
-
Mumbai
MAHARASHTRA
400012
India 
Phone  9284659047  
Fax  -  
Email  komalgaikwad466@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Archana Gore 
Designation  Assistant Professor 
Affiliation  Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai 
Address  402, Physiotherapy School and centre,Seth G.S. Medical College and KEM Hospital, OC Building, E Borges Road ,Opposite Tata Hospital, Parel, Mumbai
Physiotherapy School and Centre, Seth G.S Medical College and KEM Hospital, Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  9082621220  
Fax    
Email  nilarch17@yahoo.co.in  
 
Source of Monetary or Material Support  
Physiotherapy School and Centre, Seth G.S. Medical College and KEM Hospital, Parel East Mumbai 12 
 
Primary Sponsor  
Name  Physiotherapy school and Centre Seth G S Medical College and KEM Hospital 
Address  Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai, 400012 
Type of Sponsor  Government medical college 
 
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 Archana Gore   Physiotherapy Department , Pediatric OPD and Epilepsy Care Clinic of KEM Hospital  1st floor,Physiotherapy School and Centre, Seth G. S. Medical College and KEM Hospital, OC Building, E Borges Road, opposite Tata Hospital, Parel, Mumbai Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 
9082621220

nilarch17@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics Committee, Seth G.S. Medical College and KEM Hospital, Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G809||Cerebral palsy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. The participants will be parents of children with cerebral palsy of age group 4-12 years visiting a paediatric neuro OPD, Epilepsy care clinic on Tuesday and paediatric medicine OPD on Thursday at tertiary care hospital between period of July 2024 to February 2025.
2. The parents will be able to read and understand either of these three languages English, Hindi, Marathi. 
 
ExclusionCriteria 
Details  The parents who are not willing to participate  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Manual Ability Classification System  Once at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Cerebral Palsy Quality Of Life Questionnaire   Once at baseline  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/07/2024 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Cerebral palsy is a motor disability which is non-progressive and is caused by damage to CNS at or around birth. The CPQOL child is a condition specific QOL Questionnaire designed for children with CP. Primary Caregiver questionnaire evaluating seven domains appears to have very good reliability and validity. We are using a primary caregiver proxy report for children aged 4–12 years is parent reported version of CPQOL in this study. The Manual Ability Classification System (MACS) describes how children with cerebral Palsy (CP) use their hands to handle objects in daily activities. MACS describes five Levels .MACS can be used for children aged 4–18 years. For MACS the Interrater reliability between the parent and therapist was excellent (ICC between parents and therapists was 0.96) and Interrater reliability between therapists was excellent (ICC was 0.97). This Study is Correlation and Observational study and  study duration will be 1 year. Study population will be children with CP who will visits at pediatric neuro physiotherapy opd between period of July 2024 to February 2025.  

This  study will be conducted during routine treatment session of the child. Written consent will be explained to parents and signed by the parents, guardians of the subjects explaining purpose of the study. CPQOL hard copies will be given to the parents of cerebral palsy children , parents should answer the questionnaire and return it back to the investigator in 15-20 minutes. MACS assessment  will be done in routine OPD in this therapist should observed how child with cerebral palsy use their hand to handle objects and according to that  grading will be recorded .The levels are based on the children’s ability to handle objects and their need for assistance to perform manual activities. For assessment colorful, different size toys used to find out MACS score. Data will be collected and statistically analyzed.

 
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