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CTRI Number  CTRI/2025/02/079962 [Registered on: 06/02/2025] Trial Registered Prospectively
Last Modified On: 04/02/2025
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   Impact of Core Stability Exercises and Diaphragmatic Training on Lung Function in Smartphone Users with Forward Head Posture 
Scientific Title of Study   Effect of Core Stability Exercises and Diaphragmatic Training on Pulmonary Function in Smartphone Users with Forward Head Posture 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Palvi Malhotra 
Designation  Masters Of Physiotherapy Student 
Affiliation  Guru Nanak Dev University 
Address  Department Of Physiotherapy, Guru Nanak Dev University, Amritsar-143005, Punjab, India.

Amritsar
PUNJAB
143005
India 
Phone  8847619532  
Fax    
Email  pallavimalhotra353@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Palvi Malhotra 
Designation  Masters Of Physiotherapy Student 
Affiliation  Guru Nanak Dev University 
Address  Department Of Physiotherapy, Guru Nanak Dev University, Amritsar-143005, Punjab, India.

Amritsar
PUNJAB
143005
India 
Phone  8847619532  
Fax    
Email  pallavimalhotra353@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Palvi Malhotra 
Designation  Masters Of Physiotherapy Student 
Affiliation  Guru Nanak Dev University 
Address  Department Of Physiotherapy, Guru Nanak Dev University, Amritsar-143005, Punjab, India.

Amritsar
PUNJAB
143005
India 
Phone  8847619532  
Fax    
Email  pallavimalhotra353@gmail.com  
 
Source of Monetary or Material Support  
Guru Nanak Dev University , Amritsar-143005, Punjab, India. 
 
Primary Sponsor  
Name  Palvi Malhotra 
Address  Department Of Physiotherapy, Guru Nanak Dev University, Amritsar-143005, Punjab, India. 
Type of Sponsor  Other [Physiotherapy] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Maman Paul  Assistant Professor, Department Of Physiotherapy, Guru Nanak Dev University , Amritsar-143005, Punjab, India. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrMaman Paul  Guru Nanak Dev University  Department Of Physiotherapy, Guru Nanak Dev University, Amritsar-143005, Punjab, India.
Amritsar
PUNJAB 
9815459353

mamanpaul@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Guru Nanak Dev University, Amritsar- 143005 (India) (Established by the State Legislature Act No.21 of 1969)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Forward Head Posture 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1.Core Stability Exercises 2.Diaphragmatic Training   No control Group 
Intervention  Core Stability Exercises Diaphragmatic Training   Core Stability Exercises focus on strengthening the muscles in your abdomen, lower back, hips, and pelvis—muscles that are responsible for providing stability and support to the spine. Frequency of the intervention will be 5days per week. Duration of the interventions will be 5 weeks. Diaphragmatic training focuses on strengthening and improving the function of the diaphragm. Frequency of the intervention will be of 5 days per week. Duration of the interventions will be 5 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  27.00 Year(s)
Gender  Female 
Details  Females who had been using their smartphones for at least one year and for more than 2.5 hours per day. They were also diagnosed with forward head posture, experienced non-specific chronic neck pain lasting longer than three months, and had a pain intensity score greater than 3 on the VAS scale. Additionally, these females had a Neck Disability Index (NDI) score ranging from 28% to 45%, a Craniovertebral angle of less than 48-50 degrees, and a thoracic curvature greater than 40 degrees. 
 
ExclusionCriteria 
Details  1. Injury or trauma to cervical spine
2. Neurological signs
3. Radiculopathy (radiating to upper limb)
4. Neck conditions like spondylolysis, spondylolisthesis etc.
5. Thoracic outlet syndrome
6. Respiratory infections
7. Nervous or musculoskeletal diseases or conditions
8. Vestibular system problems
9. Psychological disorders
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Craniovertebral angle (CVA)
Dynamic Abdominal Endurance Test
Visual analogue scale (VAS)
Neck disability index (NDI)
Forced vital capacity (FVC)
Inspiratory reserve volume (IRV)
Inspiratory capacity(IC)
Expiratory Reserve Volume (ERV)
Forced Expiratory Volume in one second (FEV1)
 
Outcome variables will be Assessed Baseline and after 6 weeks for both intervention groups. 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
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)   15/02/2025 
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="1"
Days="5" 
Recruitment Status of Trial (Global)   Completed 
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 Title of this study EFFECT OF CORE STABILITY EXERCISES AND DIAPHRAGMATIC TRAINING ON PULMONARY FUNCTION IN SMARTPHONE USERS WITH FORWARD HEAD POSTUREThis study aims to investigate the effects of core stability exercises and diaphragmatic training on craniovertebral angle (CVA), Dynamic Abdominal Endurance Test, Visual analogue scale (VAS), Neck disability index (NDI), Forced vital capacity (FVC), Inspiratory reserve volume (IRV), Inspiratory capacity (IC), Expiratory Reserve Volume (ERV), Forced Expiratory Volume in one second (FEV1) in smartphone users with forward head posture (FHP).  Forward head posture (FHP) is characterized by positioning the head excessively anteriorly in relation to an imaginary plumb line that is perpendicular to the body’s center of gravity causing insufficient control over abdominal muscles, which increases thoracic kyphosis. FHP and non specific chronic neck pain (NSCNP) often have weak deep neck flexors, leading to overuse of compensatory muscles like the sternocleidomastoid and scalene. This imbalance overloads the cervical spine and affects the thoracic spine, resulting in respiratory and neck function deficits that impact both neck movement and breathing. The study will involve 60 females aged 18-27, with craniovertebral angle <48-50 degrees,  >40 degree thoracic curvature and non specific chronic neck pain >3months,  and will compare two intervention groups Group A will receive core stability exercises and diaphragmatic training. Group B will receive conservative treatment and diaphragmatic training. The outcomes variables include  craniovertebral angle (CVA), Dynamic Abdominal Endurance Test, Visual analogue scale (VAS), Neck disability index (NDI), Forced vital capacity (FVC), Inspiratory reserve volume (IRV), Inspiratory capacity (IC), Expiratory Reserve Volume (ERV), Forced Expiratory Volume in one second (FEV1).  These parameters will be assessed pre- and post-intervention. The study aims to provide a better understanding of how these combined treatments can improve forward head posture, reduce neck pain, and improve respiratory function. It could have clinical significance by offering non-invasive methods to counteract the musculoskeletal and respiratory issues caused by prolonged smartphone users with forward head posture.

 
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