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CTRI Number  CTRI/2025/06/088984 [Registered on: 17/06/2025] Trial Registered Prospectively
Last Modified On: 17/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Relation between hand length, strength and hand function in children with Down syndrome 
Scientific Title of Study   Correlation of upper extremity muscle strength and upper extremity length with hand function in children with Down syndrome - 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  Chhaya Mahadeo Dhurde  
Designation  MPT Scholar 
Affiliation  MGM School of Physiotherapy MGM Institute of Health Sciences 
Address  MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy 2nd floor room no 115 MGM Hospital Sector 1 Plot 1 and 2 Kamothe Navi Mumbai Taluka Panvel

Raigarh
MAHARASHTRA
410209
India 
Phone  9511726311  
Fax    
Email  chhayadhurde@mgmsopnm.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Amrita Ghosh  
Designation  Associate Professor 
Affiliation  MGM School of Physiotherapy MGM Institute of Health Sciences 
Address  MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy 2nd floor room no 115 MGM Hospital Sector 1 Plot 1 and 2 Kamothe Navi Mumbai Taluka Panvel

Raigarh
MAHARASHTRA
410209
India 
Phone  02227437866  
Fax    
Email  aghosh@mgmsopnm.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Amrita Ghosh  
Designation  Associate Professor 
Affiliation  MGM School of Physiotherapy MGM Institute of Health Sciences 
Address  MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy 2nd floor room no 115 MGM Hospital Sector 1 Plot 1 and 2 Kamothe Navi Mumbai Taluka Panvel


MAHARASHTRA
410209
India 
Phone  02227437866  
Fax    
Email  aghosh@mgmsopnm.edu.in  
 
Source of Monetary or Material Support  
MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy 2nd floor room no 55 MGM Hospital Sector 1 Plot 1 and 2 Kamothe Navi Mumbai Taluka Panvel Raigarh MAHARASHTRA 410209 India  
 
Primary Sponsor  
Name  MGM School of Physiotherapy MGM Institute of Health Sciences 
Address  MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy 2nd floor room no 115 MGM Hospital Sector 1 Plot 1 and 2 Kamothe Navi Mumbai Taluka Panvel Raigarh MAHARASHTRA 410209 India  
Type of Sponsor  Private medical college 
 
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 Amrita Ghosh   MGM School of Physiotherapy MGM Institute of Health Sciences, Special schools in navi mumbai  MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy, 2nd floor room no. 115 MGM Hospital, Sector 1 Plot 1 and 2 Kamothe, Navi Mumbai Taluka Panvel
Raigarh
MAHARASHTRA 		 02227437866

aghosh@mgmsopnm.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Mahatma Gandhi Missions Dental College and Hospital  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 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Participants to be children aged 6 to 15 years with a medical diagnosis of Down syndrome (DS) confirmed by a pediatrician, Eligible children should be classified at Level 1 of the Gross Motor Function Classification System (GMFCS), meaning they can walk independently at home, school, and in the community, as well as climb stairs without using a railing. While they are capable of performing gross motor skills like running and jumping, their speed, balance, and coordination may be limited. Additionally, participants must demonstrate the ability to understand and follow simple verbal commands. 
 
ExclusionCriteria 
Details  Participants will be excluded if they have undergone recent surgery of the upper extremity or spine within the last six months, have musculoskeletal injuries or cardiovascular conditions that could hinder the assessment process, or demonstrate an inability to understand and follow simple verbal commands. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
● Hand function using Sollerman Hand Function Test
● Upper extremity length using measuring tape
● Hand strength using Jamar Hydraulic Hand Dynamometer and hydraulic pinch gauge
● Upper extremity strength using seated medicine ball throw test
 		 Baseline  
 
Secondary Outcome  
Outcome  TimePoints 
●Hand dexterity using Nine hole peg test Minnesota manual dexterity board  Baseline 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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)   30/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/06/2025 
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 cross sectional study investigates the correlation between upper extremity length muscle strength and hand function in children with Down syndrome The study includes children aged 6-15 years medically diagnosed with Down syndrome. Exclusion criteria are visual/hearing impairments, recent surgery, musculoskeletal injuries, and cardiovascular conditions. Outcome measures include assessments of upper extremity length (whole upper limb, upper arm, forearm, hand, and hand span), upper extremity muscle strength (medicine ball throw test, handheld dynamometer), and hand function evaluations (Minnesota Manual Dexterity Test, Nine-hole peg test and Sollerman Hand Function Test). Need of the study is to investigate the hand function deficits in children with Down syndrome as impaired hand function substantially impacts ability to perform daily living activities and thereby compromising their independence and overall quality of life so It is important to know the components which contribute to alter the hand function for designing targeted interventions to optimize manual dexterity, facilitating enhanced autonomy in daily activities This study aims to contribute to understanding the relationship between upper extremity length, muscle strength, and hand function in Down syndrome children. 
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