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CTRI Number  CTRI/2024/09/073948 [Registered on: 17/09/2024] Trial Registered Prospectively
Last Modified On: 17/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Correlation between FHP, Neck disability index and CTA in young adults. 
Scientific Title of Study   Correlation between forward head posture, Neck disability index and clavicular tilt angle in young adults. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Patel Dhruvi Rajeshbhai  
Designation  Post Graduate  
Affiliation  Ahmedabad institute of medical sciences  
Address  AIMS Campus Ahmedabad Institute of Medical Sciences Near SP Ring Road Ognaj circle Near Lions Karnavati Eye Hospital Gota Kalol Highway Lapkaman Ahmedabad

Ahmadabad
GUJARAT
380060
India 
Phone  9714571562  
Fax    
Email  dhruvip8798@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  T Kanna Amarnath 
Designation  Lecturer, PG Guide  
Affiliation  Ahmedabad Institute of Physiotherapy 
Address  Room No 1 Devision Exercise Therapy Department Physiotherapy Ahmedabad Institute Of Medical Sciences Nr S P Ring Road Ognaj Circle Gota Kalol Highway Lapkaman Ahmedabad

Ahmadabad
GUJARAT
380060
India 
Phone  9943787226  
Fax    
Email  ruthracha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  T Kanna Amarnath 
Designation  Lecturer, PG Guide  
Affiliation  Ahmedabad Institute of Physiotherapy 
Address  Room No 1 Devision Exercise Therapy Department Physiotherapy Ahmedabad Institute Of Medical Sciences Nr S P Ring Road Ognaj Circle Gota Kalol Highway Lapkaman Ahmedabad


GUJARAT
380060
India 
Phone  9943787226  
Fax    
Email  ruthracha@gmail.com  
 
Source of Monetary or Material Support  
Ahmedabad Institute of Medical Sciences Near SP Ring Road Ognaj Circle Gota Kalol Highway Lapkaman Ahmedabad Gujarat India 380060  
 
Primary Sponsor  
Name  Ahmedabad Institute of Medical Sciences 
Address  Room No 1 Devision Exercise Therapy Physiotherapy Ahmedabad Institute of Medical Sciences Near SP Ring Road Ognaj Circle Gota Kalol Highway Lapkaman Ahmedabad Gujarat India 380060 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr T Kanna Amarnath  Ahmedabad Institute of Medical Sciences  Room no 1 Devision Exercise Therapy Department Physiotherapy Ahmedabad Institute Of Medical Sciences Nr.S.P.Ring Road Ognaj Circal Gota-Kalol Highway Lapkaman Ahmedabad Gujarat India 380060 Ahmadabad
Ahmadabad
GUJARAT 
9943787226

ruthracha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research And Ethics Committee  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 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  34.00 Year(s)
Gender  Both 
Details  Willingness of subject to participate in study
Rounded shoulder posture
Forward head posture CVA less than 53
 
 
ExclusionCriteria 
Details   Surgery in neck ,back or shoulder
 Clavicle fracture
Fracture in back and shoulder
Shoulder dislocation
Metal implantation
Malignancy
Infection
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Craniovertebral angle
Clavicular tilt angle 
After The Observation  
 
Secondary Outcome  
Outcome  TimePoints 
Rounded Shoulder Posture
Modified Neck Disability Index  
After The Observation 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   01/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/03/2025 
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)  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   NEED OF THE STUDY

             In, India Young adults generation account for more than 66% (808 million) of the total population. The nation’s future lies in the hands of these very adolescents who will grow up to be the driving force of the economy, and thus, the promotion and protection of their health becomes a priority.

             Poor posture is common during adolescence, and the popularization of personal electronic gadgets have led to sustained and frequent periods of sitting behind monitors, and visual display terminal syndrome. Muscular and skeletal structures can change into an incorrect shape due to a reduction in physical activity and inappropriate posture habits in daily living. long-term use of smartphones and personal computers causes FHP, stiffness in the muscles around the neck, chest and back, leads to an imbalance in muscular pattern, reduces the epidemiological function of the body, and weakens soft tissues.

            Forward head and rounded shoulder posture [FHRSP] is a common clinical postural misalignment. FHP that causes round shoulder and neck pain due to an imbalance between the curvature of the spine and muscles that are attached to the neck bone, is correlated with problems in the neck bone. FHP & RSP deform the normal relationship of muscles and the bone structure which are correlated.

             The pectoralis, upper trapezius, and levator scapulae muscles are shortened, and upper-crossed syndrome is caused by weakened deep cervical flexors, lower trapezius, rhomboid, and serratus anterior muscles. FHP causes RSP and limits the working range of the head and neck due to pain.

              The clavicle bone is connected strongly to a number of muscles, and accordingly to fascies. Through the fascies of the neck and the pectoral region the clavicle is functionally joined with the internal and external jugular veins as well as with the subclavian vein. By intermittent contraction of the muscles related to the fascies, and by movement of the clavicle, the structures mentioned work jointly as a circulation and ventilation pump for the arm, head and neck.

 

              An alteration in clavicular tilt angle may indicate a change in muscles length and joint alignment that precludes optimal motion with abnormal scapular alignment may affect the muscles length of deltoid, upper trapezius, subclavius muscle causing alteration and possibly joint pain. The clavicular tilt angle can be used an indicator to determine the presence of a depressed or downward rotated scapula for these reasons, clavicular tilt angle is important for upper extremity evalution.

             Till the date no further study done on relationship between FHP, NDI and Clavicular tilt angle So, here the need of my study is find the correlation between clavicular tilt angle differences and forward head rounded shoulder posture.

 

 

 

 

 

 

 

 

 

 

 

 

 

                                                AIM

§  The aim of this study to find out the any correlation between forward head rounded shoulder posture (FHRSP) , neck disability index and clavicular tilt angle in young adults.

 

                                                      OBJECTIVE

To find out the correlation between forward head rounded shoulder posture and to measure neck pain and functional disability by measuring craniovertebral angle, clavicular tilt angle in kinovea or J software and modified neck disability index.

PROCEDURE:

 

Before the experiment, according to the Declaration of Helsinki, the purpose and procedures of the study were fully explained to all subjects, and all subjects subsequently voluntarily agreed to enroll in the present study.

All subjects would be screened keeping in mind the inclusion and exclusion criteria and subjects and those who are appropriate to the study would be chosen.

Written consent form will be signed by subjects who will be included in study.

MEASUREMENT OF CV ANGLE FOR FORWARD HEAD POSTURE

In this study photogrammetry method, a digital imaging technique was used to evaluate the head and neck posture. An iphone 15 pro max has a trio of lenses: wide, ultrawide and telephoto. The main camara has a 48- megapixel sensor, while the other two have a resolution of 12-megapixel   camera was placed at a distance of 1.5 meter from a subject distance and height was adjusted according to the level of the subject’s shoulder, colored body markers was placed on tragus of ears and C7cervical spine of the subjects. The participant was asked to face straight and positioned lateral to the camera.

First, subjects were instructed to sit on a chair in a straight position and ankle, knee and hip joint at 90ºand face forward. The researcher asked the subject to flex and ex­tend the neck for a few times before assuming the sitting resting posture. All participants were instructed, prior to photo capturing, to assume a relaxed resting posture while looking forward at the target with arm rested beside the body. Then, three sagittal plane photos were taken by the digital camera from each side and saved to a personal com­puter for further analysis. Repeated photographs aimed at reducing bias due to subject’s tension during photography capturing as well as to overcome the difference between measurements because of postural swaying [34].

Then the photography was transferred to computer and analyzed using kinovea software. A virtual line was drawn between the midpoint of tragus to C7 spinous process and a horizontal line through the spinous process of C7vertebrae. Subjects having CV angle less than 50Ë™ would be considered as having forward head posture.

 

MEASUREMENTS OF ROUNDED SHOULDER POSTURE

All the subjects who participated in the experiments were instructed to sit on a chair with, to position their ankle, knee, and hip joint at 90° and to face forward. Photos were taken using smartphones to classify the degrees of the upper crossed syndrome, and the photos were analyzed using Dartfish software (DFKOREA, Korea). The distances between the lateral centre line of the shoulder and the lateral centre line of the ear were measured, and those with the lateral centre line of the shoulder positioned less than 1 cm forward from the lateral centre line of the ear were classified as the normal group, those with the lateral centre line of the shoulder positioned 1–2.5 cm forward from the lateral centre line of the ear were classified as the mild upper crossed syndrome group, and those with the lateral centre line of the shoulder positioned 2.5–5 cm forward from the lateral centre line of the ear were classified as the moderate upper crossed syndrome group [9].

 

MEASUREMENTS OF CLAVICULAR TILT ANGLE

The subjects Sit straight with neutral forearm and resting hand position at the sides. The examiner marked two landmarks with round stickers at the midpoint of the end of the medial clavicle and the midpoint of the end of the lateral clavicle (Ha et al, 2013). Then, a digital camera captured a photographic image 2 m away from the subject’s frontal side. Clavicular tilt angle was defined as the angle between the             line joining the medial and lateral end of the clavicle and a horizontal line from the medial end of the clavicle (Akel et al, 2008) and was calculated automatically using Image kinovea software.

                             

 

Modified Neck disability indices (NDI) were used to measure neck pain and functional disability, and consisted of 10 items: degree of pain, daily living, lifting, reading, headache, concentration level, work, driving, sleep and leisure activity, each of which was graded from 0 to 5, to a total of 0–55. 0–4 represented no disability, 5–14, mild disability, 15–24, moderate disability, 25–34, severe disability, and ≥35, complete disability [14].


 
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