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CTRI Number  CTRI/2019/09/021046 [Registered on: 03/09/2019] Trial Registered Prospectively
Last Modified On: 26/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effect of Play oriented exercises on hand skills in Children with Developmental Coordination Disorder 
Scientific Title of Study   Long term Effect of Task Oriented approach on Dexerity in Children with Developmental Coordination Disorder- A Randomized Controlled Trail 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  STEPHIN BABU 
Designation  MASTER OF PHYSIOTHERAPY(MPT) Student 
Affiliation  Nitte institute of physiotherapy 
Address  Ground floor, Room no. 20, Nitte Institute of Physiotherapy, K S Hegde Medical Sciences Complex, Nitte University, Derlakatte, Mangalore-Dakshina Kannada 575018 India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9739425001  
Fax    
Email  stephinbabu001@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  MRS SUCHETHA P S 
Designation  Associate Professor 
Affiliation  Nitte institute of physiotherapy 
Address  Ground floor, Room no. 20, Nitte Institute of Physiotherapy, KS Hegde Medical Sciences complex, Nitte University, Derlakatte, Mangalore-Dakshina Kannada India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448441292  
Fax    
Email  suchetaps.bhat@gmail.com  
 
Details of Contact Person
Public Query  
Name  STEPHIN BABU 
Designation  MASTER OF PHYSIOTHERAPY(MPT) Student 
Affiliation  Nitte institute of physiotherapy 
Address  Ground floor, room no. 20, Nitte Institute of Physiotherapy, K S Hegde Medical Sciences complex, Nitte University, Derlakatte, Mangalore-Dakshina Kannada India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9739425001  
Fax    
Email  stephinbabu001@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy KS Hegde Hospital Derlakatte Mangalore 
 
Primary Sponsor  
Name  Nitte University 
Address  Department of Physiotherapy KS Hegde Hospital Derlakatte Mangalore 
Type of Sponsor  Research institution and hospital 
 
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 
STEPHIN BABU  Kuthar Government school  Kuthar Government school, Munnar, Mangalore 575018
Dakshina Kannada
KARNATAKA 		 9739425001

stephinbabu001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: F59||Unspecified behavioral syndromes associated with physiological disturbances and physical factors,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Task oriented approach, handout of upper limb coordination exercises.  Placing pegs, Threading lace, shifting pegs, threading nuts on a bolt, turning pegs, cutting out elephant Duration: 40 minutes, 2 sessions a week for 4 weeks 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1) The acquisition and execution of coordinated motor skills is substantially below that expected given the individual’s chronological age and opportunity for skill learning and use.
2) The motor skills deficit in Criterion A significantly and persistently interferes with activities of daily living appropriate to chronological age and impacts academic/ school productivity and vocational activities, leisure and play.
3) Onset of symptoms is in the early developmental period
4) Age between 8 to 12 years
 
 
ExclusionCriteria 
Details  1) The motor skills deficits are not better explained by intellectual or visual impairment and are not attributable to neurological condition affecting movement.
2) Children who has episode of seizures
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Nine hole pegboard test
 		 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation Tool of Children’s handwriting–Cursive (ETCH–C)
 		 6 months 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   05/09/2019 
Date of Study Completion (India) 20/02/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 20/02/2020 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
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 randomized controlled trial is aiming at finding the effectiveness on dexterity by giving various task oriented exercises in children with developmental coordination disorder . 
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