| CTRI Number |
CTRI/2023/11/059623 [Registered on: 07/11/2023] Trial Registered Prospectively |
| Last Modified On: |
05/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
THE IMPACT OF STRETCHING EXERCISES AND ERGONOMICS ON RISK OF DEVELOPING MUSCULOSKELETAL DISORDERS AND DISABILITY IN NATIONALISED BANKERS-AN Randomized clinical trial
|
|
Scientific Title of Study
|
THE IMPACT OF STRETCHING EXERCISES AND ERGONOMICS ON RISK OF DEVELOPING MUSCULOSKELETAL DISORDERS AND
DISABILITY IN NATIONALISED BANKERS -AN Randomized clinical trial
|
| 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 Sharvari Jagdish Joshi |
| Designation |
Masters of Community Physiotherapy Student |
| Affiliation |
Maharashtra Institute of Physiotherapy |
| Address |
Maharashtra Institute of Physiotherapy MIMSR Medical College Campus Ambajogai Latur Rd Vishwanathpuram Latur Maharashtra 413531
Latur
MAHARASHTRA
413531
India |
| Phone |
8668921834 |
| Fax |
|
| Email |
sharujj29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyam Jungade |
| Designation |
Associate Professor and HOD of Community Department |
| Affiliation |
Maharashtra Institute of Physiotherapy |
| Address |
Maharashtra Institute of Physiotherapy MIMSR Medical College Campus Ambajogai Latur Rd Vishwanathpuram Latur Maharashtra
Latur
MAHARASHTRA
413531
India |
| Phone |
9860246678 |
| Fax |
|
| Email |
jshyamphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shyam Jungade |
| Designation |
Associate Professor and HOD of Community Department |
| Affiliation |
Maharashtra Institute of Physiotherapy |
| Address |
Maharashtra Institute of Physiotherapy MIMSR Medical College Campus Ambajogai Latur Rd Vishwanathpuram Latur Maharashtra
Latur
MAHARASHTRA
413531
India |
| Phone |
9860246678 |
| Fax |
|
| Email |
jshyamphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra Institute of Physiotherapy Latur |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute of Physiotherapy |
| Address |
Maharashtra Institute of Physiotherapy MIMSR medical College Campus Ambajogai Latur Rd vishwanathpuram Latur |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sharvari Joshi |
Maharashtra Institute of Physiotherapy |
Maharashtra Institute of Physiotherapy MIMSR college Campus Ambajogai latur Rd Vishwanathpuram Latur
Latur
MAHARASHTRA |
8668921834
sharujj29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharashtra Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A - Stretching Exercises |
Group A -
1 Upper trapezius stretch (30 sec hold × 2 sets)
2 Levator scapulae stretch(30 sec hold × 2 sets)
3 Pectoralis stretch (30 sec hold × 2 sets) |
| Comparator Agent |
Group B - Stretching exercises along with ergonomic advice |
Group B-
Streatching
1 Upper trapezius stretch (30 sec hold × 2 sets)
2 Levator scapulae stretch(30 sec hold × 2 sets)
3 Pectoralis stretch (30 sec hold × 2 sets)
Ergonomic Advice
1.Chair and Desk Setup
2.Monitor Placement:
3.Keyboard and Mouse:
4.Lighting
5.Breaks and Movement
6.Organization
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.At least one year of work experience
2.Age between 25 to 35
3.Male and female both
4.Patient willing to participate
|
|
| ExclusionCriteria |
| Details |
1.A staff those had a history of accidents affecting the musculoskeletal system (fracture of spine or limbs due to car accident or fall),
2.Spinal surgery
3.Major surgery in any part of the body
4.Congenital anomalies such as spine and limb anomaly
5.Pregnant women
6.Not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Rapid Upper Limb Assessment Scale RULA
2.Disabilities of the Arm Shoulder and Hand (DASH) questionnaire |
Pre Intervention Assessment
Post Intervention Assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
13/11/2023 |
| 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="0"
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
|
The patients with age ranging between 25-35 years will be selected in the study. Participants will be selected on the basis of inclusion and exclusion criteria. The entire procedure will be explained to the subjects. The informed written consent will be taken from the subjects. Participants will be allocated according to simple random sampling in the 2 experimental groups. Before starting the treatment, all participants will be assessed for risk of developing musculoskeletal disorders and disability can be assessed by using rapid upper limb assessment scale and disabilities of the arm, shoulder and hand (dash) questionnaire. Their scores will be recorded as pre-treatment scores Group A will undergo for Stretching Exercises Group B will undergo for Stretching Exercises along with Ergonomic advices Protocaol should be explained for home based exercise. After four week all participants will be assessed for risk of developing musculoskeletal disorders and disability. Their scores will be recorded as a post – treatment scores. |