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CTRI Number  CTRI/2023/08/057131 [Registered on: 31/08/2023] Trial Registered Prospectively
Last Modified On: 26/07/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Increased joint mobility and associated musculoskeletal problems in school going children 
Scientific Title of Study   Correlation between hypermobility and musculoskeletal pain in pre-adolescent school going children 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Adwaid Nambiar 
Designation  Lecturer 
Affiliation  Alvas College of Physiotherapy and Research Centre 
Address  Department of Physiotherapy Alvas College of Physiotherapy and Research Centre Moodubidire DK

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9789906015  
Fax    
Email  adwaidnambiar777@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Hariharasudhan Ravichandran 
Designation  Professor 
Affiliation  Alvas College of Physiotherapy and Research Centre 
Address  Department of Physiotherapy Alvas Health center Complex Alvas College of Physiotherapy and Research Centre Moodubidire DK

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9789906015  
Fax    
Email  hrkums63@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Hariharasudhan Ravichandran 
Designation  Professor 
Affiliation  Alvas College of Physiotherapy and Research Centre 
Address  Department of Physiotherapy Alvas Health Center complex Alvas College of Physiotherapy and Research Centre Moodubidire DK

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9789906015  
Fax    
Email  hrkums63@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy Alvas College of Physiotherapy and Research Centre Moodubidire, DK Karnataka 
 
Primary Sponsor  
Name  Alvas College of Physiotherapy and Research Centre  
Address  Department of Physiotherapy Alvas College of Physiotherapy and Research Centre, Moodubidire, DK 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
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 Hariharasudhan Ravichandran  Alvas College of Physiotherapy and Research Centre  Department of Physiotherapy Moodubidire, DK
Dakshina Kannada
KARNATAKA 		 9789906015

hrkums63@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board of Alvas College of Physiotherapy and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy children 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  NIl 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Regular program school children were recruited

Children with Beighton score more than 5 out of 9

Students with good hearing and visual acuity

Congenital joint hypermobility 
 
ExclusionCriteria 
Details  No recent or past musculoskeletal injuries and pain

No congenital deformities

No other systematic illness

History of immobilization of upper extremity and lower extremity in the past

History of surgery in upper extremity and lower extremity ince past 6 months 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Beighton scale score
Nordic musculoskeletal pain questionnaire 		 Baseline  
 
Secondary Outcome
Modification(s)  		   
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/09/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  07/09/2023 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [hrkums63@gmail.com].

  6. For how long will this data be available start date provided 09-09-2023 and end date provided 09-11-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Hypermobile joints are associated with age, gender, ethnicity, physical activities, and pathological conditions. Children tend to possess a greater range of joint mobility compared to the adult populations. It is also evident that female  children predominate in joint mobility than the males. The primary cause of joint hypermobility is collage changes in the capsule and other non contractile tissues supporting the joint. The impact of joint hypomobility and musculoskeletal disorders were well reported in the literature. The objective of this study is to investigate the correlation between joint hypermobility and musculoskeletal pain in preadolescent school going childrens. 
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