| 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 |
|
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Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
Details of Secondary Sponsor
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q909||Down syndrome, unspecified, |
|
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Intervention / Comparator Agent
|
|
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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
|
|
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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
|
|
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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. |