| 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
|
|
|
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
|
|
|
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
|
|