| CTRI Number |
CTRI/2025/06/089481 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the Effects of Posture Correction, Eye Movement Training, and Their Combination on Eye Strain and Neck Posture in Teenagers with Digital Eye Strain: A Study with Three Groups |
|
Scientific Title of Study
|
Evaluation Of Comparative Efficacy Of Postural Correction, Oculomotor - Gaze Stability Training And Combined Interventions On Asthenopia And Craniovertebral Angle In Adolescents With Digital Eye Strain: A Three Arm Parallel Comparative 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 Shilpa Chourasia |
| Designation |
Professor HOD |
| Affiliation |
VSPMs College of Physiotherapy |
| Address |
Musculoskeletal Department VSPMs College of Physiotherapy Digdoh Hills Hingna Road Nagpur Maharashtra
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9970571112 |
| Fax |
|
| Email |
drshilpahatewar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishnu Vaardhan |
| Designation |
Professor HOD |
| Affiliation |
Ravi Nair College of Physiotherapy |
| Address |
Musculoskeletal Department Ravi Nair College of Physiotherapy Sawangi Meghe Wardha Maharashtra
Ravi Nair college of physiotherapy lata mangeshkar hospital hingna road nagpur
Nagpur
MAHARASHTRA
442107
India |
| Phone |
8379917421 |
| Fax |
|
| Email |
vishnu.vardhan@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa Chourasia |
| Designation |
Professor HOD |
| Affiliation |
VSPMs College of Physiotherapy |
| Address |
Musculoskeletal Department VSPMs College of Physiotherapy Digdoh Hills Hingna Road Nagpur Maharashtra
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9970571112 |
| Fax |
|
| Email |
drshilpahatewar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Shilpa Chourasia |
| Address |
Musculoskeletal Department VSPMs College of Physiotherapy Digdoh Hills Hingna Road Nagpur Maharashtra India 440019 |
| 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 Shilpa Chourasia |
Ravi Nair College of Physiotherapy |
Musculoskeletal Department Sawangi Meghe Wardha Maharashtra India 442107
Nagpur
MAHARASHTRA |
9970571112
drshilpahatewar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Ravi Nair College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Postural correction exercises |
Conventional group receives postural correction exercises which includes a program of strengthening and stretching exercises for posture correction for 4 weeks |
| Intervention |
Postural correction exercises and oculomotor - gaze stability exercises
|
Group A receives postural correction exercises which includes a program of strengthening and stretching exercises for posture correction and
Group B receives oculomotor - gaze stability exercises which includes 1. Blinking exercise
2. Saccadic Eye
Movement
3. Smooth pursuit
4. Gaze stabilization-
move head up/down and right/left and other exercises.
Group C receives oculomotor - gaze stability exercises with postural
correction exercises which involves the combination of exercises from previous two groups for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
1 Subject showing cardinal signs of digital eye strain or computer vision syndrome with
CVS Q score more than 6
2. Adolescents Age 10 to 19 years
3. Near point convergence more than 10 cm
4. Subjects having Asthenopia survey questionnaire 17 score more than 12 and half
5. Craniovertebral angle more less than 50 degrees
6. Both male and female subjects
7. Those who has given the consent |
|
| ExclusionCriteria |
| Details |
1. Cases who had participated in a neck rehabilitation program during the past three months.
2. Patients with a history of systemic disease and any type of head, cervical or shoulder trauma.
3. Patient having any history of head, cervical spine or shoulder surgery.
4. Patient having any pathological or neurological problem
5. Vertebrobasilar insufficiencies
6. Adolescents not willing to participate
7. Organic disorders of eye such as Glaucoma, Eye injury, Eye infections, Malignancy, Squintmyopia , any
other refractive error.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Near point convergence for convergence insufficiency
2. Craniovertebral angle |
4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Asthenopia survey questionnaire -17score |
4 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
07/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
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 study titled as EVALUATION OF COMPARATIVE EFFICACY OF POSTURAL CORRECTION, OCULOMOTOR - GAZE STABILITY TRAINING AND COMBINED INTERVENTIONS ON ASTHENOPIA AND CRANIOVERTEBRAL ANGLE IN ADOLESCENTS WITH DIGITAL EYE STRAIN: A THREE ARM PARALLEL COMPARATIVE TRIAL Comprises Of Three Groups In Which Group A Receives Postural Correction Exercises, Group B Receives Oculomotor - Gaze Stability Exercises And Group C Receives Oculomotor - Gaze Stability Exercises With Postural Correction Exercises. The Primary Outcome Measures In This Study Are Near Point Convergence For Convergence Insufficiency And Craniovertebral Angle. The Secondary Are Asthenopia Survey Questionnaire -17 score |