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CTRI Number  CTRI/2024/11/076872 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 09/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Cluster Randomized Trial 
Public Title of Study   Application for Musculoskeletal Assessment and Screening in Sports Athletes 
Scientific Title of Study   Designing, Developing and Testing a Mobile Application for Musculoskeletal Assessment and Screening in Sports Athletes: A Multiphasic Exploratory 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  Dipendra Gadhiya 
Designation  Post Graduate Student 
Affiliation  School of Physiotherapy, RK University 
Address  Research Department, Room no. 207, School of Physiotherapy, RK University kasturbadham Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India.

Rajkot
GUJARAT
360020
India 
Phone  9106388002  
Fax    
Email  dgadhiya569@rku.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Komal Doshi  
Designation  Assistant Professor 
Affiliation  School of Physiotherapy, RK University 
Address  Research Department, Room no. 207, School of Physiotherapy, RK University kasturbadham Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India.

Rajkot
GUJARAT
360020
India 
Phone  7405346112  
Fax    
Email  komal.doshi@rku.ac.in  
 
Details of Contact Person
Public Query  
Name  Dipendra Gadhiya 
Designation  Post Graduate Student 
Affiliation  School of Physiotherapy, RK University 
Address  Research Department, Room no. 207, School of Physiotherapy, RK University kasturbadham Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India.

Rajkot
GUJARAT
360020
India 
Phone  9106388002  
Fax    
Email  dgadhiya569@rku.ac.in  
 
Source of Monetary or Material Support  
School of Physiotherapy, RK University Kasturbadham Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India.  
 
Primary Sponsor  
Name  Dipendra Gadhiya 
Address  School of Physiotherapy , RK University, Kasturbadham , Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India  
Type of Sponsor  Other [self] 
 
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 
Dipendra Gadhiya  RK Physiotherapy rehabilitation and research centre  Physiotherapy Department, Room no.1, opp. Meghanirang bhuvan bhaktinagar circle Rajkot, Gujarat, India.
Rajkot
GUJARAT 		 09106388002

dgadhiya569@rku.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, School of Physiotherapy, RK University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Musculoskeletal conditions 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Muscle Energy Techniques  Frequency : 5 Days/Week for 2 Weeks. 
Comparator Agent  Traditional Method: Myofascial Release  Frequency:5 Days/week for 2 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1. Various sports athletes.
2. Age: 18 to 35 years
3. Gender: male and female both
4. Regular participation in sports or physical activities (at least 3 times per week and minimum 3 years) 
 
ExclusionCriteria 
Details  1. Persons with Cardiac diseases
2. Persons with Respiratory diseases
3. Persons who doesn’t play regular.
4. Uncooperative participants 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Range of motion, Manual Muscle Testing  Baseline day 1 and after 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   02/12/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - 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 -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dgadhiya569@rku.ac.in].

  6. For how long will this data be available start date provided 05-05-2025 and end date provided 26-12-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Title: Designing, Developing and Testing a Mobile Application for Musculoskeletal Assessment and Screening in Sports Athletes: A Multiphasic Exploratory Study

Investigator: Dipendra Gadhiya1, Dr. Komal Doshi2

Background: 

Musculoskeletal screening is a process used to assess the condition and function of the musculoskeletal system, which includes bones, muscles, joints, tendons, and ligaments. This type of screening is typically performed by healthcare professionals such as physical therapists, chiropractors, orthopaedic surgeons, or sports medicine doctors. This is used to address the potential musculoskeletal injuries issues, prevent injuries, and develop appropriate treatment or exercise plans for rehabilitation. Here are the key components and purposes of musculoskeletal screening: Injury Prevention, Early Detection, Rehabilitation, Performance Optimization, Health Promotion. The assessment of musculoskeletal problems in athletes is crucial for injury prevention, but the current manual paper-based recording system can lead to bias, lost records, and insecure data storage. There is a need for a patient-centric digital musculoskeletal screening system that simplifies therapist access, supports recovery tracking, and replaces paper records, improving efficiency and accessibility in the sports field. This app stands out from others typically used in education because it will specifically use as a comprehensive assessment tool for physiotherapists. It offers essential features such as data storage, seamless data forwarding, and both pre- and post-assessment data collection, making it an invaluable resource.

PHASE-1:Survey to identify the need of application. 

PHASE-2: Design and develop a mobile application.

PHASE-3: To check the reliability and validity of application to evaluate musculoskeletal issues in sports athletes.

 
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