| CTRI Number |
CTRI/2024/11/077210 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational Therapy ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The aim is to find out how common muscle and joint problems are among occupational therapists and create a plan to help prevent and treat these issues. |
|
Scientific Title of Study
|
Effect of Ergonomic Intervention on Musculoskeletal Disorder among
Occupational Therapists Working in Paediatric setup of Odisha |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankita Rout |
| Designation |
Assistant Professor |
| Affiliation |
Sri Sri University |
| Address |
Room No-112, Faculty of Health and Wellness,1st Floor, Shruti Building, Sri Sri University, Godi Sahi, Ward no 3, Bidyadharpur,Cuttack
Cuttack
ORISSA
754006
India |
| Phone |
07504101095 |
| Fax |
|
| Email |
ankitaroutanku@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ankita Rout |
| Designation |
Assistant Professor |
| Affiliation |
Sri Sri University |
| Address |
Room No-112,Faculty of Health and Wellness, Shruti Building, 1st Floor, Sri Sri University, Godi Sahi,Ward No-3, Bidyadharpur,Cuttack
Cuttack
ORISSA
754006
India |
| Phone |
07504101095 |
| Fax |
|
| Email |
ankitaroutanku@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ankita Rout |
| Designation |
Assistant Professor |
| Affiliation |
Sri Sri University |
| Address |
Room No-112,Faculty of Health and Wellness, Shruti Building, 1st Floor, Sri Sri University, Ward No-3,Godi Sahi, Bidyadharpur, Cuttack
Cuttack
ORISSA
754006
India |
| Phone |
07504101095 |
| Fax |
|
| Email |
ankitaroutanku@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Tirthankar Ghosh |
| Address |
Dean, Faculty of Health and Wellness, Shruti Building ,!st Floor,Sri Sri University, Bidyadharpur,Ward No 3,Godi Sahi,Cuttack,Odisha,754006 |
| 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 |
| Dr Ankita Rout |
Sri Sri University |
Faculty of Health and Wellness, 1st Floor, Shruti Building, Sri Sri University, Godi Sahi, Bidhyadharpur
Cuttack
ORISSA |
07504101095
ankitaroutanku@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical Research of Faculty of Health and Wellness,Sri Sri college of Ayurvedic Science and Research Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Occupational Therapist who are working in pediatric setup having musculoskeletal complaints. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ergonomic Intervention |
Rest break
Workplace Exercises
Educating, training, or counseling on ergonomics and or safe patient handling
Duration of treatment -2 times /day
(10 min to 15 min)
Repetition - 3
Weekly 6 Days
For 6 weeks
|
| Comparator Agent |
Stretching Exercises will be given for 2 Twice Daily For 6 Days.
Work Rest Breaks will given 5 minutes after one Patient |
Postural correction Exercises
Occupational Therapists who are working in Pediatric Setups in Odisha have musculoskeletal disorders The above-mentioned interventions will be given to prevent musculoskeletal problems.
|
|
|
Inclusion Criteria
|
| Age From |
22.00 Day(s) |
| Age To |
42.00 Day(s) |
| Gender |
Both |
| Details |
Occupational Therapist working in pediatric setup and having 2 years of experience. |
|
| ExclusionCriteria |
| Details |
- Occupational Therapist with any other physical abnormalities and less than 1yr of working experience
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analoque Scale
Posture analysis
-RULA ,REBA
- Time study
- STRESS ASSESSMENT - perceived stress questionnaire
- Cognitive assessment - mental status scale
- Eye stress
- Reaction time
|
Baseline , 1 Week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
STRESS ASSESSMENT - perceived stress questionnaire
- Cognitive assessment - mental status scale
- Eye stress
- Reaction time |
Baseline and After 1 Week |
|
|
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="8"
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 - NO
|
|
Brief Summary
|
Occupational therapists are risk of work-related injuries because of
the demanding nature of their work.
The therapist who goes for therapy sessions
during an 8hr/day work on 15 to 20 patients experiences more risk of work
damage. This study aims to develop and apply an effective intervention . |