| 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
|
|
|
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
|
|
|
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 exÂtend 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 comÂputer 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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