| CTRI Number |
CTRI/2024/09/073675 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
07/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To identify the effect of Jandas approach versus Functional corrective exercise on neck posture and functional disability on the college going students with the forward head posture - Comparative study |
|
Scientific Title of Study
|
Effectiveness of Jandas approach versus Functional corrective exercise on neck posture and functional disability in the individuals with the forward head posture - A Comparative 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 |
Rivoli Bhimani |
| Designation |
Student |
| Affiliation |
Parul University |
| Address |
division - Parul university
department - department of physiotherapy and engneering
room no - 208 and 310
Vadodara GUJARAT 391760 India |
| Phone |
8269175306 |
| Fax |
391760 |
| Email |
rivolibhimani2000@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dwija Yagnik |
| Designation |
Assistant Professor |
| Affiliation |
Parul University |
| Address |
division - Parul university
department - department of physiotherapy and engneering
room no - 208 and 310
Vadodara GUJARAT 391760 India |
| Phone |
9909021553 |
| Fax |
391760 |
| Email |
dwija2988@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Dwija Yagnik |
| Designation |
Assistant Professor |
| Affiliation |
Parul University |
| Address |
division - Parul university
department - department of physiotherapy and engneering
room no - 208 and 310
GUJARAT 391760 India |
| Phone |
9909021553 |
| Fax |
391760 |
| Email |
dwija2988@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul University ,limda waghodia ,Vadodara , Gujarat , India 391760 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| Rivoli Bhimani |
Parul Institute of Physiotherapy and Parul Institute of Engineering and Technology |
Division - Parul University
Department - Department of Physiotherapy and Engineering
Room no - 208 and 310 Vadodara GUJARAT |
8269175306 391760 rivolibhimani2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University (IECHR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Functional Corrective Exercise |
Duration - 40 mins
Frequency - 12 repetations
12 sessions for 4 week (3 sessions per week) |
| Comparator Agent |
Jandas Approach |
Duration - 45 mintues
Frequency - 10 repetations
12 sessions for 4 weeks ( 3 sessions per week) |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1)Willing to participate
2)Both male and female
3)Cranioverterbral (cv) angle less than 48 degrees
4)Pain present more than 2 months
5)Participants who didn’t take part in previous study
6)Subjects agree to give written informed conset.
|
|
| ExclusionCriteria |
| Details |
1)Cervical surgery and cervical spine fracture
2)Congenital abnormalities
3)Temporomandibular surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Kinovea Software
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neck disability index |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="84" Sample Size from India="84"
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)
|
26/09/2024 |
| 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 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
|
AIM : To find out the effectiveness of Jandas approach versus functional
corrective exercises on neck posture and functional disability on individuals
with the forward head posture. INTRODUCTION : The most common way to define forward head posture (FHP) is as
excessively anterior head orientation with respect to a vertical reference line
(1) It shifts the centre of gravity forward from the vertebrae. As a result,
the cervical musculature experiences excessive stress, leading to muscular
imbalanced There are the various study that
proves the high prevalence of forward head posture. Researchers have estimated
that upto 63.93% of individuals including male and female having forward head
posture (2) The anterior position of the cervical spine is also known as
"text neck" or forward head posture (FHP)."Reading neck,"
"wearies neck," and "scholar’s neckâ€. This postural issue is
brought on by a number of things, such as sleeping with the head raised too
high, using computers, laptops, and cell phones In UCS, pectoralis major tightness crosses over with dorsal side levator
scapula and upper trapezius tightness and small. The middle and lower trapezius
muscles are weak in conjunction with the deep cervical flexors ventrally
crossed. In particular, at the atlanto-occipital joint, C4-C5 segment,
cervicothoracic joint, glenohumeral joint, and T4-T5 segment, this pattern of
imbalance results in joint dysfunction. Specific postural changes are seen in
UCS, including forward head posture NEED OF THE STUDY : An increase in
cervical lordosis, rounded shoulders, kyphosis, and pain are caused by
restricted conditions and repetitive tasks that shorten and stiffen certain
muscles (such as the upper trapezius, levator scapulae, and deep neck flexors)
and inhibit and weaken others (such as the lower and middle trapezius). This
imbalanced posture results in these abnormalities. Students studying computers
and software frequently have a forward head posture This study
would probably apply the comparison effect in physiotherapy treatments because
no other study compared these two protocols The purpose of Jandas approach was to see the effectiveness of stretching
and strengthening exercises in upper cross syndrome and functional corrective
exercises used as a therapeutic intervention to target misaligned posture. Conducting a comparative study between these two protocols would focus on
specific mechanism and which aspect is more effective in improving neck posture
and reduce functional disability. PROCEDURE : After taking approval from ctri and ethical committee informed consent will be taken from the patients and pre assessment will be done according to the inclusion criteria. Participants will be divided into two equal groups in Group A will receive Janadas approach for 4 weeks and Group B will receive Functional corrective exercise for 4 weeks and post assessment will be taken after for weeks. Conclusion of the study will be made after statistical analysis. |