| CTRI Number |
CTRI/2024/12/078837 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Physiotherapist Safety: A Study on Ergonomic Risk Factors |
|
Scientific Title of Study
|
Ergonomic risk factors assessment among physiotherapists using HEMPA method: 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 |
Dr Jyoti Sharma |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Room No E005 Department of Physiotherapy Plot No2 Sector 17A Opposite Yamuna Expressway Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
971161626 |
| Fax |
|
| Email |
jsharmaphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Sharma |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Room No E005 Department of Physiotherapy Plot No2 Sector 17A Opposite Yamuna Expressway Greater Noida
UTTAR PRADESH
203201
India |
| Phone |
971161626 |
| Fax |
|
| Email |
jsharmaphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhaskar Kumar |
| Designation |
Research Scholar |
| Affiliation |
Galgotias University |
| Address |
Room No E04 Department of Physiotherapy Plot No2 Sector 17A Opposite Yamuna Expressway Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8709375899 |
| Fax |
|
| Email |
bhaskarkumar0011@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research and Development cell, Galgotias University, Plot No2, Sector 17A, Opposite Yamuna Expressway, Greater Noida, Gautam Buddha Nagar
UTTAR PRADESH 203201
India
|
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Plot No2, Sector 17A, opposite Gautam Buddha International circuit, Yamuna expressway, Greater Noida |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Jyoti Sharma |
E005, Department of Physiotherapy, Galgotias University |
Plot No 2, Sector 17A, Opposite Gautam Buddha International Circuit Yamuna expressway
Gautam Buddha Nagar
UTTAR PRADESH |
9717161626
jsharmaphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Ethics Committee, Plot No2, Sector 17A, Opposite Yamuna Expressway, Greater Noida, Gautam Buddha Nagar UTTAR PRADESH 203201 India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Physiotherapist |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Physiotherapists eligible for the study include those currently employed in secondary or tertiary hospitals with over one year of work experience work-related musculoskeletal disorders. They should be practicing in Noida and Greater Noida, aged between 25 to 65 years, and willing to provide written informed consent. Additionally, they must not have undergone specific ergonomic training in the past year. |
|
| ExclusionCriteria |
| Details |
The study excludes physiotherapists employed in primary care hospitals, those with less than one year of experience, and those holding only a diploma in physiotherapy. It also excludes physiotherapists with musculoskeletal disorders from accidents or injuries, those practicing outside Noida and Greater Noida, and pregnant physiotherapists due to unique ergonomic considerations. Additionally, physiotherapists younger than 25 or older than 60, and those who have undergone surgery for musculoskeletal disorders in the past five years, are excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HEMPA Method |
Baseline and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="323"
Sample Size from India="323"
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)
|
05/11/2025 |
| 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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bhaskarkumar0011@gmail.com].
- For how long will this data be available start date provided 30-04-2025 and end date provided 31-07-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NA
|
|
Brief Summary
|
Ergonomic Risk Factors Assessment Among Physiotherapists Using HEMPA Method: A Cross-Sectional Study":
Objective: This study aims to identify and analyze ergonomic risk factors among physiotherapists, who are often exposed to musculoskeletal risks due to the nature of their work, such as prolonged standing, repetitive movements, and patient handling. Using the HEMPA (Handling Ergonomics Mobility Posture Assessment) method, the study focuses on assessing how these risk factors contribute to musculoskeletal disorders in physiotherapists. Methodology: A cross-sectional study design is applied, and data collection involves observing and recording ergonomic postures and handling techniques used by physiotherapists during their routine tasks. The HEMPA tool will specifically be utilized to evaluate each task for ergonomic risks, factoring in aspects like work organization, patient dependency levels, and repetitive strain from handling activities. Expected Outcome: The study aims to highlight key ergonomic risk factors that physiotherapists face and recommend preventive strategies. It hopes to provide valuable insights to develop safer work environments and reduce the incidence of musculoskeletal disorders within the physiotherapy profession. |