| CTRI Number |
CTRI/2025/05/087737 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
21/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of improving shoulder blade support and upper back posture on head position, breathing and hand skills in young adults with forward leaning head. |
|
Scientific Title of Study
|
Effect of scapular stabilization and thoracic extension on craniovertebral angle, single breath count test and hand dexterity in young adults 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 |
Dr Jyotsna Thosar |
| Designation |
Assistant Professor |
| Affiliation |
P.T. School and Centre, Seth G.S. Medical college and K.E.M. Hospital |
| Address |
OPD 402, Room No.1, Physiotherapy Department, P.T. School and Centre, Seth G.S. Medical College and KEM Hospital, Acharya Donde Marg, Parel East, Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9821066016 |
| Fax |
|
| Email |
jyotsnathosar@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyotsna Thosar |
| Designation |
Assistant Professor |
| Affiliation |
P.T. School and Centre, Seth G.S. Medical college and K.E.M. Hospital |
| Address |
OPD 402, Room No.1, Physiotherapy Department, P.T. School and Centre, Seth G.S. Medical College and KEM Hospital, Acharya Donde Marg, Parel East, Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9821066016 |
| Fax |
|
| Email |
jyotsnathosar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Disha Joshi |
| Designation |
Masters of Physiotherapy (Musculoskeletal Sciences) |
| Affiliation |
P.T. School and Centre, Seth G.S. Medical college and K.E.M. Hospital |
| Address |
OPD 402, Room no. 1,Physiotherapy Department, P.T. School and Centre, Seth G.S. Medical College and KEM Hospital, Acharya Donde Marg, Parel East, Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8879132082 |
| Fax |
|
| Email |
joshi_sanjay@rocketmail.com |
|
|
Source of Monetary or Material Support
|
| P.T. School and Centre, Seth G.S. Medical college and K.E.M. Hospital, Mumbai Maharashtra, India
400012 |
|
|
Primary Sponsor
|
| Name |
Dr Jyotsna Thosar |
| Address |
OPD No. 402, P.T. School and Centre, Seth G.S. Medical college and K.E.M. Hospital, Acharya Donde Marg, Parel East, Mumbai, Maharashtra, India
400012 |
| 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 Jyotsna Thosar |
P.T. School and Centre, Seth G.S. Medical college and K.E.M. Hospital |
Room No 1,OPD No. 402, Physiotherapy Department, P.T. School and Centre, Seth G.S. Medical college and K.E.M. Hospital, Acharya Donde Marg, Parel East, Mumbai
MAHARASHTRA
400012
Mumbai
MAHARASHTRA |
9821066016
jyotsnathosar@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee, Seth G.S. Medical college and K.E.M. Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Young adults with forward head posture |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Physiotherapy |
A protocol involving scapular stabilization and thoracic extension exercises will be performed by the subjects.
Scapular stabilization involves exercises targeting the following muscles - rhomboids, middle, lower trapezius and serratus anterior.
Thoracic extension exercises will be performed as follows -
1. Supine position using a foam roller
2. Sitting position using a swiss ball
3. Prone position by lifting up and putting down the upper body while supporting the body with both the elbows.
The total duration of the intervention will be three weeks with the exercises being performed thrice a week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Age : 18-25 years of age
2. Gender : Both males and females will be included in the study.
3. Subjects willing to participate.
4. Subjects with forward head posture( CVA less than or equal to 50 degrees) |
|
| ExclusionCriteria |
| Details |
1. Young adults with acute or chronic neck pain
2. Subjects with a history of any other musculoskeletal, neurological, or psychiatric
disorders.
3. Any history of recent spine or upper limb surgery.
4. Presence of any other congenital or acquired musculoskeletal deformities.
5. Young adults undergoing fitness training for upper quadrant
6. Prior history of any cardiorespiratory disorders that might interfere with pulmonary
function. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Craniovertebral Angle using MB-ruler software
2. Single breath count
3. Hand Dexterity using Nine-hole peg test |
Twice, at baseline and after 3 weeks of intervention. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
15/07/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Forward head posture (FHP) is characterised by displacement of the head anteriorly with
respect to the line of gravity. FHP results in excessive flexion at the lower cervical spine (C4
C7) and extension at the upper cervical spine (C1-C3). FHP produces imbalance of several
neck muscles, inhibition of mid scapular retractors thereby altering both scapular position and
kinematics. Failure of the head to align with the vertical axis of the body can cause other
malalignments throughout the body, such as rounded shoulders and increased thoracic
kyphosis to compensate for the altered location of the LOG, resulting in further impairments.
Thus to rectify head and neck posture, it is necessary to work on the thoracic spine as well.
Nowadays, smartphones and other touch-screen portable devices play a big part in people’s
daily lives because they are utilised for gaming, internet surfing, education and
communication especially by the younger population. This usage pattern compels the user to
assume an uncomfortable position, including forward neck flexion, which is frequently
sustained for extended periods of time which is the primary cause of postural disorders like
FHP. Hence it is important to work on the FHP developing in young adults as early as
possible to prevent its complications from developing. 32 participants will be recruited based
on inclusion and exclusion criteria. Informed consent will be taken and if they agree to
participate, they will be included in the study. The participants will be called for 30 mins
thrice a week for 3 weeks during the study. They will be asked about their demographic data.
An intervention protocol including 4 exercises for scapular stabilization targeting rhomboids,
middle trapezius, lower trapezius, serratus anterior and 3 exercises for thoracic extension will
be given to the participants during these sessions. Craniovertebral angle, single breath count
test and nine-hole peg test will be the outcome measures taken before and after the
intervention. The horizontal line through C7 and the line joining C7 to the tragus constitute
the cranio-vertebral angle. It will be measured using the photographic method through the
computer program MB- Ruler software. The camera that will be used to take pictures of the
participants will be set up on a tripod 1.5 meters from the individuals, with a height of 115
cm from the camera. The single breath count will be measured by asking subjects to take
a deep breath and count as far as possible in their normal voice at an approximate rate of 2
counts per second. The better of 2 attempts will be recorded. The Nine Hole Peg test will be
used to assess the hand dexterity. The total time required by the participants to insert and
remove the pegs from the peg board will be measured in seconds. After the data collection, it
will be analysed using the statistical tests. Depending upon normality of the data, Paired t test
or Wilcoxon signed rank test will be used. |