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CTRI Number  CTRI/2024/12/078113 [Registered on: 16/12/2024] Trial Registered Prospectively
Last Modified On: 14/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prevalence of scapular dyskinesis in bus drivers.  
Scientific Title of Study   Prevalence of scapular dyskinesis and its associated factors in professional bus drivers an observational 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  Abhignya M 
Designation  Postgraduate student  
Affiliation  KLE Institute of Physiotherapy  
Address  Opd 39, advanced physiotherapy centre, Sagar floor, KLEs Dr Prabhakar kore hospital and medical research centre, Nehru Nagar, belagavi

Belgaum
KARNATAKA
590010
India 
Phone  8951042049  
Fax    
Email  anmalihalli@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Deepti Bagewadi  
Designation  Associate professor  
Affiliation  KLE Institute of Physiotherapy  
Address  Opd 39, advanced physiotherapy centre, Sagar floor, KLEs Dr Prabhakar kore hospital and medical research centre, Nehru Nagar, belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9964608727  
Fax    
Email  deeptibagewadi@klekipt.edu.in  
 
Details of Contact Person
Public Query
 
Name  Vijayalaxmi Kanabur 
Designation  Assistant professor  
Affiliation  KLE INSTITUTE OF PHYSIOTHERAPY 
Address  Opd 39, advanced physiotherapy centre, Sagar floor, KLEs Dr Prabhakar kore hospital and medical research centre, Nehru Nagar, belagavi

Belgaum
KARNATAKA
590010
India 
Phone  8867480565  
Fax    
Email  vvdeeksha@gmail.com  
 
Source of Monetary or Material Support  
"Advanced Physiotherapy Centre", OPD number 39, Sagar floor, KLEs Dr.Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belagavi, 590010 
 
Primary Sponsor  
Name  Abhignya Malihalli  
Address  Opd number 39, "Advanced Physiotherapy Centre", Sagar floor, KLEs Dr.Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belagavi, 590010 
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 
Abhignya Malihalli  KLE INSTITUTE OF PHYSIOTHERAPY  Opd number 39, "Advanced Physiotherapy Centre", Sagar floor, KLEs Dr.Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belagavi, 590010
Belgaum
KARNATAKA 
8951042049

anmalihalli@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL RESEARCH AND ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M999||Biomechanical lesion, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL   NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  49.00 Year(s)
Gender  Male 
Details  KSRTC bus drivers
• Participants who are in this profession since 5 years or more.
• Participants working for 8 hours or more per day.
• Age group: 25-49 years 
 
ExclusionCriteria 
Details  Injuries not sustained while driving;
• Accident/crash-related injuries
• Pre-existing injuries; or
• Altered driving surface (dirt racing track) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Digital Inclinometer for scapular humeral rhythm
• Push Pull dynamometer for strength
• Universal goniometer for range of motion 
baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="382"
Sample Size from India="382" 
Final Enrollment numbers achieved (Total)= "382"
Final Enrollment numbers achieved (India)="382" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/12/2024 
Date of Study Completion (India) 21/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary   PREVALENCE OF SCAPULAR DYSKINESIS AND ITS ASSOCIATED FACTORS IN PROFESSIONAL BUS DRIVERS - AN OBSERVATIONAL STUDY
AIM: To estimate the prevalence of scapular dyskinesis and its associated factors in professional bus drivers 
OBJECTIVE OF THE STUDY: To estimate the prevalence of scapular dyskinesis using digital inclinometer and its associated factors like range of motion using universal goniometer, strength using push and pull dynamometer.
RESEARCH QUESTION: How many professional bus drivers have scapular dyskinesis and its associated factors?
Inclusion criteria: • KSRTC bus drivers • Participants who are in this profession since 5 years or more. • Participants working for 8 hours or more per day. • Age group: 25-49 
Exclusion criteria: • Injuries not sustained while driving; • Accident/crash-related injuries • Pre-existing injuries; or • Altered driving surface (dirt racing track)
 OUTCOME MEASURES: • Digital Inclinometer • Push Pull dynamometer  • Universal goniometer
PROCEDURE: • Ethical clearance will be obtained from the Institutional Ethical Committee. • Study will be registered in CTRI prospectively • Subjects will be screened for Inclusion and exclusion criteria before the enrolment into the study. • The purpose and need of the study will be explained to all the participants. • The confidentiality of the subjects will be maintained. • Written informed consent will be obtained from all the participants • Demographic data will be obtained from the participant • Participants will Undergo various assessments for scapular humeral rhythm, strength of shoulder, elbow and scapular stabilizing muscles, range of motion of shoulder elbow and neck • Data will be entered in excel sheet • The collected data will be summarized by using the Descriptive Statistics: frequency, percentage; mean and S.D. To compare difference in proportions (Identification of factors); the Chi square / Likelihood ratio / Fisher’s exact test will be used. The p value < 0.05 will be considered as significant. Data will be analyzed by using the SPSS software (SPSS Inc.; Chicago, IL) version 29.0.10.
 
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