| CTRI Number |
CTRI/2024/07/070182 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
07/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Enhancing Schoolchildrens Posture: Strengthening and Stretching Effects on Scapular and Neck Muscles in Forward Head Posture
|
|
Scientific Title of Study
|
Effects of strengthening and stretching on the scapular and neck muscles in schoolchildrens forward head:A Pilot study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surbhi Singh |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
E-005,Galgotias University Plot No. 2, Yamuna Expresway, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
6204874418 |
| Fax |
|
| Email |
surbhirajput62048@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NEERAJ KUMAR |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Galgotias university ,E-005,Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9810434830 |
| Fax |
|
| Email |
neeraj9953@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Surbhi Singh |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Galgotias University,E-005, Plot No. 2, Yamuna Expressway, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
6204874418 |
| Fax |
|
| Email |
surbhirajput62048@gmail.com |
|
|
Source of Monetary or Material Support
|
| Galgotias University Sector-17A, Yamuna Expressway, Gautam Buddh Nagar, Greater Noida - 203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neeraj Kumar |
Department of physiotherapy |
B-512, Galgotias University, Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida,
Gautam Buddha Nagar
UTTAR PRADESH |
9810434830
neeraj9953@gmail.com |
| Neeraj Kumar |
School Of Allied Health Sciences Galgotias University |
B512,Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9810434830
neeraj9953@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy school students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Perform Conventional exercises exercises on Group B |
Active and passive exercises of Upper Trapezius, Levator scapulae, Sternocleidomastoid, and Posterior cervical extensor muscles for 2 time per week for 4 weeks |
| Intervention |
Stretching and Strenghthening on Group A |
Stretching and Strenghthening Exercise,Side Flexion and Extension,Neck rotationChin-to-chest- in 2 time per week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
School student
|
|
| ExclusionCriteria |
| Details |
Neuromuscular disorder including, Congenital muscular dystrophy, congenital myopathies, limb girdle muscular dystrophy, friedreich ataxia and musculoskeletal disorders including dysplasia of the hip, legg-Calve Perthes disease, slipped capital femoral epiphysis, osgood-Schlatter disease, patellofemoral syndrome, and radial head subluxation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Strenghthening exercises used during four weeks training program And Stretching exercises used during four weeks training program |
4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Strengthening intervention for assessing forward head posture |
4 week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
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
|
Posture-
Position or attitude of the body, the relative arrangement of bodily components
for a particular task, or a distinctive way of bearing one’s body are all
considered forms of posture .Increased flexion of the upper thoracic region and
lower cervical spine, as well as increased extension of the upper cervical
spine are characteristics of forward head posture (FHP). Poor posture is a
major health issue that increases the risk of musculoskeletal diseases as
people age.(Kang et al., 2018) FHP(Forward Head Posture)- When the head and upper neck bones
are extended and the lower neck bone is bent, the cervical spine is positioned
anteriorly, creating forward head posture.(Kang et
al., 2018)
It
can occur because of anterior translation of the head, lower cervical flexion,
or both, and it is claimed to be associated with an increase in upper cervical
extension. It is associated with shortening of the upper trapezius, the
posterior cervical extensor muscles, the sternocleidomastoid muscle, and
levator scapulae muscle. It can occur because of anterior
translation of the head, lower cervical flexion, or both, and it is claimed to
be associated with an increase in upper cervical extension. It is associated
with shortening of the upper trapezius, the posterior cervical extensor
muscles, the sternocleidomastoid muscle, and levator scapula muscle.(Verma, 2018).It
can occur because of anterior translation of the head, lower cervical flexion,
or both, and it is claimed to be associated with an increase in upper cervical
extension. It is associated with-
1.Shortening
of the upper trapezius. 2.The
posterior cervical extensor muscles. 3.The
sternocleidomastoid muscle 4.
Levator scapulae muscles (Verma, 2018)
Over time, this posture
results in shorter adaptability in the suboccipital muscles, posterior
ligaments, and membranes associated with the atlanto- axial and
atlanto-occipital joints [8]. This causes an increase in lordosis and
shortening of the occipital muscles. It further causes abnormal and continuous
muscle contraction and relative compensatory action of the muscles of the
occipital bone, neck, and shoulders, resulting in a change in the shape of the
cervical lordosis [9]. Eventually, the forward neck posture causes muscle
weakness in the deep flexors of the cervical spine, which not only reduces neck
stability but also causes pain. |