| CTRI Number |
CTRI/2024/10/075140 [Registered on: 11/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Forward Head Posture by balancing hip and back |
|
Scientific Title of Study
|
Integrative Management of Forward Head Posture Adressing Pelvic and Thoracic Influences: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dangar Bharti Naranbhai |
| Designation |
Post Graduate Student |
| Affiliation |
School of Physiotherapy, RK university |
| Address |
Research Department,Room no.207, School of Physiotherapy,RK University,Kasturbadham, Rajkot-Bhavnagar Highway,Rajkot, Gujarat,India.
Rajkot
GUJARAT
360020
India |
| Phone |
9512330853 |
| Fax |
|
| Email |
bdangar677@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Sharma |
| Designation |
Director, School of Physiotherapy, RK university |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
School of Physiotherapy, RK university, Kasturbadham, Rajkot-Bhavnagar highway,Rajkot ,Gujarat,India.
Rajkot
GUJARAT
360020
India |
| Phone |
9811281520 |
| Fax |
|
| Email |
amit.sharma@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dangar Bharti Naranbhai |
| Designation |
Post Graduate Student |
| Affiliation |
School of Physiotherapy, RK university |
| Address |
Research Department,Room no.207, School of Physiotherapy,RK University,Kasturbadham, Rajkot-Bhavnagar Highway,Rajkot, Gujarat,India.
Rajkot
GUJARAT
360020
India |
| Phone |
9512330853 |
| Fax |
|
| Email |
bdangar677@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| School of Physiotherapy, RK University, kasturbadham, Rajkot-Bhavnagar highway, Rajkot, Gujarat, India, 360020 |
|
|
Primary Sponsor
|
| Name |
School of Physiotherapy, RK University |
| Address |
Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot,Gujarat, India, 360020 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dangar Bharti Naranbhai |
RK Physiotherapy Rehabilitation and Research Center |
Physiotherapy Department,Room no. 1, opp Meghani rang Bhuvan, Bhaktinagar circle, Rajkot.
Rajkot
GUJARAT |
9512330853
bdangar677@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, School of Physiotherapy, RK University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrative Exercise And Range of Motion exercise |
This will Consist of Specific Activation of Internal Abdominal Oblique Muscle Along with Lengthening of Pectoralis muscle and Latissimus dorsi Muscle and Cervical Flexion, Extension, Lateral Flexion, Rotation for 3 days per week for 4 weeks. |
| Comparator Agent |
Range of Motion Exercise |
This will consist of Cervical Flexion, Extension, Lateral Flexion, Rotation for 3 days per week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Forward Head Posture who have Cervicovertebral Angle less than 50 Degree.
Age criteria between 18yr to 25yr. |
|
| ExclusionCriteria |
| Details |
History of Traumatic injuries and deformities
Uncooperative individual
Individual who will deny to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cervicovertebral Angle |
Baseline Day 1 and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Range of Motion of cervical spine |
Baseline Day 1 and After 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
28/11/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Title: Integrative Management of Forward Head Posture Addresing Pelvic and Thoracic Influences - A Randomized Controlled Trial
Investigator: Bharti Dangar PT, Dr Amit Sharma MPT, PhD, School of Physiotherapy, RK University
Background: Forward Head posture is characterized by hyperextension of the upper cervical vertebrae(C1-C2), forward translation of the cervical vertebrae(C3-C7), and rotation of the C1 vertebra to either side. Previous studies have indicated significant changes in cervical orientation in individuals with FHP. However, current medical practice does not recognize the influence of innate, physiological, human asymmetry on forward head posture. by Exploring the exercises designed based on physiological human asymmetry , the study seeks to provide a more comprehensive understanding of effective strategies for managing Forward head posture, pontentially offering a biomechanichal approach that can be integrated into clinical practice.
Method: Following Ethical Approval, 60 subjects will be selected based on inclusion and exclusion criteria and will recive exercises designed based on human physiological asymmetry. This exercises will be given 3 days per week for 4 weeks. outcome which is CVA angle will be taken before treatment and after 4 weeks of treatment . |