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CTRI Number  CTRI/2023/02/049378 [Registered on: 01/02/2023] Trial Registered Prospectively
Last Modified On: 03/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Profile of hand function in children with Down syndrome 
Scientific Title of Study   PROFILE OF FINE MOTOR FUNCTIONING AND GRIP STRENGTH IN CHILDREN WITH DOWN SYNDROME 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Shilpika Shyamsunder Dhuri 
Designation  Post graduate student 
Affiliation  JSS COLLEGE OF PHYSIOTHERAPY 
Address  JSS COLLEGE OF PHYSIOTHERAPY, JSS HOSPITAL CAMPUS, MG ROAD, MYSORE 570004
JSS COLLEGE OF PHYSIOTHERAPY, JSS HOSPITAL CAMPUS, MG ROAD, MYSORE 570004
Mysore
KARNATAKA
570004
India 
Phone  9137414483  
Fax    
Email  shilpikadhurijss@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Tanochni Mohanty 
Designation  Assistant professor  
Affiliation  JSS COLLEGE OF PHYSIOTHERAPY 
Address  JSS COLLEGE OF PHYSIOTHERAPY, JSS HOSPITAL CAMPUS, MG ROAD, MYSORE 570004
JSS COLLEGE OF PHYSIOTHERAPY, JSS HOSPITAL CAMPUS, MG ROAD, MYSORE 570004
Mysore
KARNATAKA
570004
India 
Phone  8097107612  
Fax    
Email  mohanty.tanu12@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ms Shilpika Shyamsunder Dhuri 
Designation  Post graduate student 
Affiliation  JSS college of physiotherapy 
Address  Pediatric physiotherapy department JSS college of physiotherapy JSS hospital campus MG road Mysore - 570004
Pediatric physiotherapy department JSS college of physiotherapy JSS hospital campus MG road Mysore - 570004
Mysore
KARNATAKA
570004
India 
Phone  9137414483  
Fax    
Email  shilpikadhurijss@gmail.com  
 
Source of Monetary or Material Support  
JSS College of physiotherapy, JSS hospital campus, MG road, Mysore- 570004 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 
Shilpika Shyamsunder Dhuri  JSS college of physiotherapy   Pediatric physiotherapy department, JSS hospital, MG road, Mysore-570004
Mysore
KARNATAKA 
09137414483
-
shilpikadhurijss@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional research committee  Approved 
 
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 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Children with Down syndrome between the age group of 06-18 years (school-going children)
2. The child should be able to follow instructions.
3. Functional vision and speech
 
 
ExclusionCriteria 
Details  The children who have not reached at least 6 years of development according to Ages and Stages Questionnaire ( ASQ) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Purdue Peg Board Dexterity test (PBDT)
2.Test of in-hand manipulation skills (TIMS)
3.Sphygmomanometer 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Nil 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   01/02/2023 
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)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

BACKGROUND: Down syndrome (also known as trisomy 21) is the most common cause of intellectual disability and motor delay. It affects growth development and social participation throughout the lifespan. People with Down syndrome now have a normal life and life role expectancy. Fine motor function is essential for daily living, social, emotional, academic, and cognitive activities. Fine motor skills and grip strength are paramount to providing a profile of a child’s strengths and weaknesses; based on the in-depth assessment; the therapist can develop individualized therapy programs to facilitate their integration into school life and employment. 

PURPOSE: To assess fine motor skills and grip strength in children with Down syndrome between the age group of 6-18 years using the Peg Board Dexterity Test, Test of In-hand Manipulation Skills, and sphygmomanometer.

BENEFITS: The child’s participation will help identify fine motor skills and grip strength in children with Down syndrome and help develop individualized therapy programs to facilitate their integration into school life and employment. This is a one-time study and the data will be used for research purposes only.

PROCEDURE: The screening will be done prior to the procedure. Demographic data (height, weight, BMI, Dominance) of each participant will be collected. For the assessment, the child will take the test while sitting comfortably on a chair with their feet flat on the ground. Dexterity, in-hand manipulation skills, and grip strength will be assessed using different tools. How quickly and accurately the child can work with their hands will be assessed. The test objects will be presented to the child and movement quality will be assessed simultaneously. For an accurate assessment of skill, video analysis will be taken. The tests are designed in the form of games to keep it interesting and scoring will be done. The child will be given adequate breaks in between the test. If the child’s attention is wavering, the test will be paused, and the child will be given a rest period and commenced.

CONFIDENTIALITY: The information produced as a result of this study will be treated as privileged and confidential. It will not be revealed without your consent. However, the information may be used for statistical analysis, publication, or teaching purposes with your right to privacy retained.

REQUEST FOR MORE INFORMATION: The participants may ask more questions about the study at any time to Shilpika Shyamsunder Dhuri who will be available to answer the questions.

REFUSAL OR WITHDRAWAL OF PARTICIPATION: Participation in the study is completely voluntary and that participant may refuse their participation or withdraw consent and discontinue at any time.

 
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