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CTRI Number  CTRI/2024/08/073011 [Registered on: 28/08/2024] Trial Registered Prospectively
Last Modified On: 25/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   The connection between how well a childs motor skills work and their ability to move around and take part in everyday activities in their community focussing on children with cerebral palsy 
Scientific Title of Study   Association of motor function skill level with functional mobility and community participation among children diagnosed with cerebral palsy A cross sectional 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  Kiran Kumari 
Designation  PG student 
Affiliation  father muller college of physiotherapy 
Address  Father Muller College Of Physiotherapy Pediatric physiotherapy floor -2 Kankanady Manguluru
Father Muller College Of Physiotherapy pediatric physiotherapy floor -2 Kankanady Mangaluru
Dakshina Kannada
KARNATAKA
575003
India 
Phone  8876899779  
Fax    
Email  kiranroy978@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ms Anupama k 
Designation  Associate professor 
Affiliation  father muller college of physiotherapy 
Address  Father Muller College Of Physiotherapy pediatric physiotherapy floor -2 Kankanady Mangaluru
father Muller College Of Physiotherapy pediatric physiotherapy floor -2 Kankanady Mangaluru
Dakshina Kannada
KARNATAKA
575003
India 
Phone  9901324366  
Fax    
Email  anupamakarkera@fathermuller.in  
 
Details of Contact Person
Public Query  
Name  Kiran Kumari 
Designation  PG student 
Affiliation  father muller college of physiotherapy 
Address  Father Muller College Of Physiotherapy pediatric physitherapy floor-2 Kankanady Mangaluru
Father Muller College Of Physiotherapy pediatric physiotherapy floor -2 Kankanady Mangaluru
Dakshina Kannada
KARNATAKA
575003
India 
Phone  8876899779  
Fax    
Email  kiranroy978@gmail.com  
 
Source of Monetary or Material Support  
Father Muller College of Physiotherapy Kankanady Mangaluru 575001 
 
Primary Sponsor  
Name  Kiran Kumari 
Address  Father Muller College of physiotherapy Kankanady, Manguluru 575002 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR Kiran Kumari  Father Muller Medical College Hospital  OPD Physiotherapy Basement -2 floor, Asha Kiran Father Muller College physiotherapy Father Muller Charitable Institutions, Kankanady, Manguluru
Dakshina Kannada
KARNATAKA 		 8876899779

kiranroy978@gmail.com 
DR Kiran Kumari  St. Agnes Special School  Opp. to St. Agnes college mallikatte Bendoor, Manguluru 575002
Dakshina Kannada
KARNATAKA 		 8876899779

kiranroy978@gmail.com 
DR Kiran Kumari  St. Marys Special School  St. Marys special school kinigoli 574150
Dakshina Kannada
KARNATAKA 		 8876899779

kiranroy978@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee (FMIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G80||Cerebral palsy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children with cerebral palsy
Age: 5 to 18years
Gender: All gender
Should be able understand simple commands  
 
ExclusionCriteria 
Details  Unwilling to participate
Neurological symptoms developed due to any other medical condition
If any fractures or any injury that affect the mobility (within six months of
study start date)
If they had undergone any surgeries for muscle tightness.
Participants with cerebral palsy above 18 years of age.
If they had undergone any surgeries within six months of study start date 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To find the impact of community participation using assistant to participate scale (APS) among the children with cerebral palsy  1 week 
 
Secondary Outcome  
Outcome  TimePoints 
To find the gross motor functional level & manual ability level among children diagnosed with cerebral palsy, using Gross motor function classification system & manual ability classification system.
 		 1 week 
To find the functional mobility using Functional Mobility Scale  1week 
 
Target Sample Size   Total Sample Size="31"
Sample Size from India="31" 
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)   10/09/2024 
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="1"
Months="0"
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   This study will help the therapist to understand children’s ability to participate in community based on outcome measures among the children with cerebral palsy. It will help in enhancing the motor skills which will lead to Independence and engagement in daily activities. 
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