| CTRI Number |
CTRI/2024/03/064080 [Registered on: 13/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
effects of rigid taping and posture correction exercises in individual with forward head posture |
|
Scientific Title of Study
|
efficacy of taping and posture correction exercises on upper fibers of trapezius in individuals with forward head posture using surface electromyography and kinovea software |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
LAXMI PRIYA S S |
| Designation |
MPT (Orthopaedics and Traumatology) |
| Affiliation |
sri Ramachandra institute of higher education and research |
| Address |
sri ramachandra institute of higher education and Research
porur,iyyapanthangal,chennai-116
600116
Ramachandra Nagar porur,chennai 600116
Tamilnadu,India
Chennai
TAMIL NADU
600116
India |
| Phone |
9003245816 |
| Fax |
|
| Email |
drlaxmipt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hepzibah Rubella D |
| Designation |
Assistant professor |
| Affiliation |
sri Ramachandra institute of higher education and research |
| Address |
sri Ramachandra institute of higher education and research
sri ramachandra faculty of physiotherapy
Ramachandra Nagar porur,chennai 600116
Tamilnadu,India
sri ramachandra faculty of physiotherapy
Ramachandra Nagar porur,chennai 600116
Tamilnadu,India
Chennai
TAMIL NADU
600116
India |
| Phone |
9600009396 |
| Fax |
|
| Email |
hepzibahd@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Hepzibah Rubella D |
| Designation |
Assistant professor |
| Affiliation |
sri Ramachandra institute of higher education and research |
| Address |
sri Ramachandra institute of higher education and research
sri ramachandra faculty of physiotherapy
Ramachandra Nagar porur,chennai 600116
Tamilnadu,India
sri ramachandra faculty of physiotherapy
Ramachandra Nagar porur,chennai 600116
Tamilnadu,India
Chennai
TAMIL NADU
600116
India |
| Phone |
9600009396 |
| Fax |
|
| Email |
hepzibahd@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| SELF |
| sri ramachandra institute of higher education and resarch (infrastructural support ) |
|
|
Primary Sponsor
|
| Name |
LAXMI PRIYA S S |
| Address |
Sri Ramachandra institute of higher education and research,ramachandra nagar,porur,chennai-116,Tamilnadu |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| LAXMI PRIYA S S |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
faculty of physiotherapy
OPD
Chennai
TAMIL NADU |
9003245816
drlaxmipt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR STUDENTS PROJECTS DHR1CMR Registration No: EC/NEW/INST/2023/TN/0321 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
individuals with forward head posture |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
posture correction exercises |
posture correction exercises ( 4 weeks ) follow-up
shoulder retraction (10 reps)
shoulder bracing (10 reps)
neck retraction (10 reps)
|
| Intervention |
rigid taping and posture correction exercises |
rigid taping application( posture correction taping ) along with posture correction exercises ( 4 weeks ) followup
shoulder retraction (10 reps)
shoulder bracing (10 reps)
neck retraction (10 reps)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female
NDI score minimum of 15 percentage
NPRS scores of minimum 3
|
|
| ExclusionCriteria |
| Details |
whiplash injury
vbi insufficiency
cervical radiculopathy |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
numeric pain rating scale
surface electromyography
kinovea software
|
4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
range of motion
neck disability index
|
4 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
23/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/03/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
- This experimental study will include individuals (students ) with forward head posture - The individuals are initially screened for forward head posture using kinovea software . all the individuals with forward head posture are randomly assigned into study and control groups . - The baseline electromyographc activities of upper trapezius in both control and study group is measured - The individuals in study group will receive taping and posture correction exercises and individuals in control group will receive postural correction exercises - Emg values of both study and control group is measured post 4 weeks of treatment and compared |