| 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
|
|
|
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
|
|
|
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. |