| CTRI Number |
CTRI/2025/05/086867 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
09/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
How E-Backnshou Exercises Help Reduce Eye Strain in Physiotherapy Students |
|
Scientific Title of Study
|
Effectiveness of E-BACKNSHOU exercise on Computer Vision Syndrome among Physiotherapy Students An Experimental 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 |
KIRUTHIGA S |
| Designation |
Student |
| Affiliation |
SRM Institute of Science and Technology, Kattankulathur |
| Address |
Room no- PT13, 5th floor, SRM College of Physiotherapy, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu 603203, Tamil Nadu, India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9585347367 |
| Fax |
|
| Email |
skiruthiga44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ASHISH MATHEW A |
| Designation |
Assistant Professor |
| Affiliation |
SRM Institute of Science and Technology, Kattankulathur |
| Address |
Room no- 14, Staff Room, 5th Floor, SRM College of Physiotherapy, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu 603203, Tamil Nadu, India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7397138762 |
| Fax |
|
| Email |
ashishma@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
ASHISH MATHEW A |
| Designation |
Assistant Professor |
| Affiliation |
SRM Institute of Science and Technology, Kattankulathur |
| Address |
Room no- 14, Staff Room, 5th Floor, SRM College of Physiotherapy, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu 603203, Tamil Nadu, India
TAMIL NADU
603203
India |
| Phone |
7397138762 |
| Fax |
|
| Email |
ashishma@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM College of Physiotherapy, SRM Institute of Science and Technology |
|
|
Primary Sponsor
|
| Name |
KIRUTHIGA S |
| Address |
Room no- PT13, 5th floor, SRM College of Physiotherapy, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu 603203, Tamil Nadu, India |
| Type of Sponsor |
Other [Funded] |
|
|
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 |
| Ashish Mathew A |
SRM College of Physiotherapy |
Room no. 10, 11, 12, 13, 5th floor, SRM College of Physiotherapy, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu 603203, Tamil Nadu, India
Kancheepuram
TAMIL NADU |
7397138762
ashishma@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H531||Subjective visual disturbances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
20-20-20 rule |
The 20-20-20 rule consists of every 20 minutes, the subjects shift their eyes to look at an object at least 20 feet away, for at least 20 seconds. |
| Intervention |
E-BACKNSHOU exercises and 20-20-20 rule |
The 20-20-20 rule consists of every 20 minutes, the subjects shift their eyes to look at an object at least 20 feet away, for at least 20 seconds. E-BACKNSHOU exercises were range of motion and stretching exercises for extremity, eye, back, neck, and shoulder with 18 minutes and 48 seconds duration, with warming up for 1 minute 36 seconds repeated once (moving eyes to all 8 directions, range of motion of both shoulder and elbow), main exercise 15 minutes 36 seconds repeated 3 times each (elbow, wrist and finger stretching, lower extremity stretching, moving eyes to all 8 directions, blink for 20 seconds, neck and back stretching) and cool down 1 minutes and 36 seconds repeated once ( moving eyes to all 8 directions, neck and arm stretching), 3 times a week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Both men and women will be included
Age group between 19 to 25 years will be included Participants experiencing symptoms of CVS neck pain and shoulder and low back pain after a minimum of 3 hours using digital devices
Participants with CVS score of 6 or more will be included
|
|
| ExclusionCriteria |
| Details |
Participants with known case of Osteoarthritis
Participants with neurological disorder
Participants who underwent recent eye surgeries
Participants who use digital devices less than 3 hours of daily screen time
Participants who had a history of mental disorder
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Computer Vision Syndrome Questionnaire
Visual Analogue Scale (VAS)
Neck Disability Index (NDI)
Shoulder Pain and Disability Index (SPADI)
Roland-Morris Disability Questionnaire (RMDQ)
|
4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
22/05/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 participants will be selected according to the inclusion and exclusion criteria. The research objectives will be explained in detail about the need and procedure of the study, then an informed consent will be obtained. Participants with Computer Vision Syndrome will be selected by Computer Vision Syndrome Questionnaire (CVS-Q) where the participants will be asked to complete the questionnaire (who obtain a score of 6 or more will be selected) to identify the presence of CVS symptoms. The pain score will be identified by using VAS scale. Assesses the impact of pain on daily activities will be measured by the Neck Disability Index (NDI), Shoulder Pain and Disability Index (SPADI), Roland-Morris Disability Questionnaire (RMDQ) -Pre Test. Participants will be divided into two groups – Experimental group and control group. The Experimental Group will trained the E-BACKNSHOU exercises and 20-20-20 rule and the control group will trained only the 20-20-20 rule. The exercise protocol will be explained on the 1st day of the session, they will perform the exercises at home with weekly follow-ups to ensure adherence and correct technique. There will be provided with visual guides for exercises to follow the home practice. The E-BACKNSHOU exercises and 20-20-20 rule will trained to experimental group for 3 times a session, 3 session per week for 4 weeks. |