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CTRI Number  CTRI/2025/02/080228 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 29/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Effect of exercise training on hand function in children with Down Syndrome 
Scientific Title of Study   Effect of exercise training on Fine Motor Skills in children with Down Syndrome: Pre-Post 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  Nivetha Moorthy 
Designation  Post-Graduate Student 
Affiliation  Manipal Academy of Higher Education 
Address  Upper basement, Department of Physiotherapy, Manipal Hospital, No. 98, Rustam Bagh, Old Airport Road, Bangalore, Karnataka, India

Bangalore
KARNATAKA
560017
India 
Phone  7904673289  
Fax    
Email  nivetha.mhsblr2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr V Prem 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Upper basement, Department of Physiotherapy, Manipal Hospital, No. 98, Rustam Bagh, Old Airport Road, Bangalore, Karnataka, India

Bangalore
KARNATAKA
560017
India 
Phone  9886647732  
Fax    
Email  prem.v@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr V Prem 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Upper basement, Department of Physiotherapy, Manipal Hospital, No. 98, Rustam Bagh, Old Airport Road, Bangalore, Karnataka, India

Bangalore
KARNATAKA
560017
India 
Phone  9886647732  
Fax    
Email  prem.v@manipal.edu  
 
Source of Monetary or Material Support  
Therapy room,Bethany Special School,8th cross road,Nirguna mandir layout,Cauvery colony,Ejipura, Bengaluru-560095 Bangalore KARNATAKA  
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Department of Physiotherapy,Manipal Hospital#98,HAL ,Old Airport Road, Bangalore,Karnataka - 560017, India 
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 
Dr Prem V  Bethany Special School  8th cross road,Nirguna mandir layout,Cauvery colony,Ejipura, Bengaluru-560095
Bangalore
KARNATAKA 		 9886647732

prem.v@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethical Research Committeee  Approved 
No Objection Certificate  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q909||Down syndrome, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fine motor exercises  Children will be undergoing exercise therapy for 6 weeks to improve fine motor skills. 3 times in a week for 30 - 45 minutes/session. 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  Children with Down Syndrome 
 
ExclusionCriteria 
Details  Children whose parents dont provide consent
Children who are unwilling to participate
Children who dont follow commands 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Fine motor function  At baseline and immediately after intervention 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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)   15/02/2025 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 16-07-2025 and end date provided 16-12-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Fine motor skills include self care activities like eating , grooming, dressing, etc and include academic activities like holding pencils and writing. To perform an efficient fine motor activity, adequate strength of small muscles of hand and hand eye coordination is necessary. The literature review states that interventional studies on fine motor abilities in Down Syndrome focused individually on manual dexterity, hand manipulation, precision, hand eye coordination and bimanual coordination. But tehre are no studies which focusede collectively on  all the above characteristics of fine motor in children with Down Syndrome. 
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