| CTRI Number |
CTRI/2025/07/090291 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Analytical study |
| Study Design |
Other |
|
Public Title of Study
|
Measurement of neck positioning angle in people with commonly seen deviation of the neck in the age group of 18 to 25 years |
|
Scientific Title of Study
|
Range of Craniovertebral angle in individuals with forward head posture in the age group of 18-45 years: An Analytical 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 |
Vaishnavi Vikas Balwadkar |
| Designation |
Postgraduate Student |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy, Pune |
| Address |
DES Brijlal Jindal College of Physiotherapy, Musculoskeletal Department, Divison 1, Room Number 2, Fergusson College Campus, Shivaji Nagar, Pune
Pune MAHARASHTRA 411004 India |
| Phone |
8378950139 |
| Fax |
|
| Email |
vaishnavi.balwadkar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Namrata Bhadbhade |
| Designation |
Assistant Professor |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy, Pune |
| Address |
DES Brijlal Jindal College of Physiotherapy, Musculoskeletal Department, Divison 1, Room Number 2, Fergusson College Campus, Shivaji Nagar, Pune
Pune MAHARASHTRA 411004 India |
| Phone |
7709404336 |
| Fax |
|
| Email |
namrata.sidhaye@despune.org |
|
Details of Contact Person Public Query
|
| Name |
Namrata Bhadbhade |
| Designation |
Assistant Professor |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy, Pune |
| Address |
DES Brijlal Jindal College of Physiotherapy, Musculoskeletal Department, Divison 1, Room Number 2, Fergusson College Campus, Shivaji Nagar, Pune
Pune MAHARASHTRA 411004 India |
| Phone |
7709404336 |
| Fax |
|
| Email |
namrata.sidhaye@despune.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vaishnavi Balwadkar |
| Address |
Geetanjali Nivas, Sr. No. 1/10, Balewadi, Pune, Maharashtra, India -411045 |
| 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 Vaishnavi Balwadkar |
Seth Tarachand Ramnath Dharmarth Ayurvedic Hospital, Rasta Peth, Pune. |
Physiotherapy OPD, Division 2, Room Number 21, Rasta Peth, Pune, Maharashtra-411011 Pune MAHARASHTRA |
8378950139
vaishnavi.balwadkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Forward Head Posture Individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Age: 18 to 45 years
Gender: both male and female
|
|
| ExclusionCriteria |
| Details |
Individuals with any frontal plane deformity at all levels of spine
Systemic disorders like rheumatoid arthritis, ankylosing spondylitis
Any acute pain (duration less than 3 months) in the cervical spine, thoracic spine and lumbar region, shoulders, and headache.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Craniovertebral angle measurement using MB Ruler software |
one time- at same time of assessment of craniovertebral angle. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| APECS App |
one time- at same time of assessment of forward head posture |
|
|
Target Sample Size
|
Total Sample Size="345" Sample Size from India="345"
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)
|
29/09/2025 |
| 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) |
Open to Recruitment |
|
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
|
In this study, range of Craniovertebral angle in individuals with forward head posture in the age group of 18-45 years. A total of 345 participants will be enrolled in this study by purposive sampling after screening on the basis of inclusion and exclusion criteria. Individuals sagittal posture analysis will be done by Plumb line and if the individual is suspected to have forward head posture then he will be photographed using APECS app for confirming forward head posture. Then the Craniovertebral angle will be analyzed using mb ruler software.The data will be documented, analyzed and results will be calculated using statistical test. Forward head posture (FHP) is the most prevalent postural deviation which is more prevalent in young individuals using smartphone, laptops and computers for prolonged period. It is associated with musculoskeletal conditions such headaches, temporomandibular problems, and muscular dysfunctions. Hence it is essential to find out the range of CVA in age group of 18-45 years. The Craniovertebral angle (CVA), measured using digital imaging, photogrammetry or radiographic techniques is a widely accepted parameter to objectively assess FHP. Still there are no consensus for defining forward head posture objectively. So by conducting this study, we can identify the range of CVA in individuals with FHP, providing an objective measure for diagnosing FHP. This will help establish clinical thresholds for diagnosis and assess the severity of postural deviations in the Indian population. |