| CTRI Number |
CTRI/2024/07/069802 [Registered on: 02/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Effectiveness Of Postural Correction Exercises Versus Postural Awareness On Smartphone Users |
|
Scientific Title of Study
|
Comparative Effectiveness Of Postural Correction Exercises Versus Postural Awareness On Forward Head Posture, Protruded Shoulder And Thoracic Kyphosis In 13-15 Years Old Smartphone Users: A Randomised Controlled 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 |
Vinutha bhandary |
| Designation |
Master of physiotherapy |
| Affiliation |
Institute of physiotherapy, Srinivas University Mangaluru |
| Address |
Institute of Physiotherapy Srinivas University, Mangaluru, Pandeshwar campus, Dakshina kannada, Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9591996508 |
| Fax |
|
| Email |
vinuthabhandari26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M Prem Kumar |
| Designation |
Associate professor |
| Affiliation |
Department of physiotherapy, Institute of physiotherapy, Srinivas University Mangaluru |
| Address |
Department of physiotherapy,Institute of Physiotherapy Srinivas University, Mangaluru, Pandeshwar, Dakshina kannada, Karnataka, India, 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9442508754 |
| Fax |
|
| Email |
80pk2009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinutha bhandary |
| Designation |
Master of physiotherapy |
| Affiliation |
Institute of physiotherapy, Srinivas University Mangaluru |
| Address |
Institute of Physiotherapy Srinivas University, Mangaluru, Pandeshwar campus, Dakshina kannada, Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9591996508 |
| Fax |
|
| Email |
vinuthabhandari26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy,Institute of physiotherapy, srinivas universe, pandeshwar campus, Mangaluru Karnataka,India, pincode-575001 |
| NIL |
|
|
Primary Sponsor
|
| Name |
Vinutha bhandary |
| Address |
Department of physiotherapy,Institute of physiotherapy, Srinivas University, pandeshwar, Mangaluru, srinivas hospital Karnataka, India, 575001 |
| Type of Sponsor |
Other [] |
|
|
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 Vinutha bhandary |
Srinivas institute of medical science, hospital |
Department of physiotherapy, Institute of physiotherapy, Srinivas university, Pandeshwar campus,Mangaluru, Karnataka, India pincode - 575001
Dakshina Kannada
KARNATAKA |
9591996508
vinuthabhandari26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Srinivas University Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
13-15 years school going children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Postural awareness |
Postural guidelines for using smartphone:
o To prevent slouching or other uncomfortable postures, sit or stand up straight.
o Avoid bending your head forward or downward by raising your smartphone upward.
o When seated, rest your elbows on the table, armrests, or your thighs for support.
o Try not to stay in one position for too long without moving.
Rest break guidelines for smartphone use:
o Take a break from using your smartphone every 20 minutes to prevent shoulder and neck muscle fatigue.
o During your break, prevent headaches and eye strain by looking at objects that are at least 20 feet away for a minimum of 20 seconds.
o Take a 20-minute break while maintaining a neutral head posture and looking straight ahead if you were using a smartphone at the time, which is not recommended as it can cause your neck muscles to become fatigued.
4days/ week for 4 weeks |
| Intervention |
Postural correction exercises |
pectoralis stretch, upper trapezius stretch, deep cervical flexors, shoulder retractors, cervical extensor strengthening exercises. These exercises will be given for 4days per week for 4 week |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female
age between 13 and 15
Who can read and write English
Smartphone Addiction Scale- short version (SAS-SV) score ≥ 31 for female, ≥ 33 for male
CVA ≥ 31 degree
Protruded shoulder ≥ 2.5cm
Thoracic kyphosis≥40 degree
|
|
| ExclusionCriteria |
| Details |
Previous shoulder surgery
Scoliosis
Cervical or thoracic fracture
Structural kyphosis
Psychiatric comorbidity
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| cranio-vertebral angle( forward head posture), supine method( pectoralis tightness), inclinometer( thoracic kyphosis) |
Pre- intervention, 3rd week and 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="1"
Months="0"
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
|
Topic: Comparative effectiveness of posture correction exercises versus posture awareness on forward head posture, protruded shoulder and thoracic kyphosis in 13-15 years smartphone users: A randomized controlled trial. The study aims to compare the efficacy of posture correction exercise
and posture awareness on FHP, protruded shoulder and thoracic kyphosis in 13-15year
smartphone users. The
use of smartphone has increased significantly across all age groups,
particularly among high school students aged between 13 and 15 years, which
leads to musculoskeletal abnormalities such as FHP, protruded shoulder and
thoracic kyphosis. Research has demonstrated that musculoskeletal abnormalities
and smartphone addiction are positively correlated, but has not been conducted
to compare the effectiveness of postural awareness and postural correction
exercises for FHP, protruded shoulder and thoracic kyphosis in high school
students. Experimental group will be getting posture correction exercises and control group will be getting postural awareness and list of exercises in a pamphlet format, which they have to do at home. |