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CTRI Number  CTRI/2023/10/058581 [Registered on: 12/10/2023] Trial Registered Prospectively
Last Modified On: 09/10/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Advanced approach for patients with Forward Head Posture to correct their Cervical angle and Quality of Life 
Scientific Title of Study   Development of an advanced Multidisciplinary Physiotherapy approach to assess the effect on Cranio-Vertebral Angle and Quality of Life in patients with Forward Head Posture- A Multi-phased 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  Apoorva Srivastava 
Designation  PhD Scholar 
Affiliation  School of Health Sciences, Chhatrapati Shahu Ji Maharaj University (CSJMU) 
Address  School of Health Sciences, Chhatrapati Shahu Ji Maharaj University (CSJMU), Kalyanpur, Kanpur

Kanpur Nagar
UTTAR PRADESH
208024
India 
Phone  8953634686  
Fax    
Email  apoorva.pt12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Apoorva Srivastava 
Designation  PhD Scholar 
Affiliation  School of Health Sciences, Chhatrapati Shahu Ji Maharaj University (CSJMU) 
Address  School of Health Sciences, Chhatrapati Shahu Ji Maharaj University (CSJMU), Kalyanpur, Kanpur

Kanpur Nagar
UTTAR PRADESH
208024
India 
Phone  8953634686  
Fax    
Email  apoorva.pt12@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Digvijay Sharma 
Designation  Assistant Professor and Director 
Affiliation  School of Health Sciences, Chhatrapati Shahu Ji Maharaj University (CSJMU) 
Address  School of Health Sciences, Chhatrapati Shahu Ji Maharaj University (CSJMU), Kalyanpur, Kanpur

Kanpur Nagar
UTTAR PRADESH
208024
India 
Phone  9839217108  
Fax    
Email  digvijaysharma@csjmu.ac.in  
 
Source of Monetary or Material Support  
Apoorva Srivastava, PhD Scholar, Chhatrapati Shahu Ji Maharaj University, Kanpur 
 
Primary Sponsor  
Name  Chhatrapati Shahu Ji Maharaj University 
Address  Chhatrapati Shahu Ji Maharaj University (CSJMU), Kanpur 
Type of Sponsor  Other [State University] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Apoorva Srivastava  Room No. SHS-106, Physiotherapy OPD  School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur
Kanpur Nagar
UTTAR PRADESH 		 8953634686

apoorva.pt12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Participants with Forward Head Posture (FHP) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Advanced Multidisciplinary Physiotherapy approach  Interventions will include set of exercises meant to correct posture, ergonomics, balance and cognition.  
Comparator Agent  Physiotherapy for Forward Head Posture  Interventions will include set of exercises meant to correct musculoskeletal anomaly with just stretching and mobilization emphasized.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Individuals between the age of 18 to 45 years.
2. Individuals who have a Cranio-vertebral Angle of less than 53 degrees, with or without pain in the cervical region.  
 
ExclusionCriteria 
Details  Individuals having history of cerebral trauma, cancer, tumour, fall or any other injury which may affect the functioning of cervical region. Individuals with systemic diseases such as Diabetes mellitus, hypertension, etc. Pregnant females and hospitalized patients. Patients of Stroke, Hemiparesis, Spinal Cord Injury, Myopathy or any neuromuscular disease. Individuals with history of fall or trauma to the cervical spine and individuals aged less than 18 or more than 45 will not be recruited.  
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1. Cranio-Vertebral Angle
2. Quality of Life 		 1. Cranio-Vertebral Angle- It will be assessed at baseline and at the end of 4 weeks of Intervention.
2.Quality of Life- It will be assessed at baseline and at the end of 4 weeks of Intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Balance
 		 1. Balance- Static & Dynamic balance of the patients with Forward Head Posture both at the baseline & after 4 weeks of Intervention.  
Cognition  Cognition is the state of functioning of brain parameters. It will be assessed both at the baseline & after 4 weeks of Intervention 
 
Target Sample Size   Total Sample Size="248"
Sample Size from India="248" 
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 2/ Phase 3 
Date of First Enrollment (India)   19/10/2023 
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="6"
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  

Background: Disruption in the normal alignment of the cervical spine with respect to the trunk, acromion process and the sagittal plane, propelling the head and cervical spine forward away from the plumb line is termed as Forward Head Posture (FHP). This FHP creates malalignment at level of cervical spine but also impacts the weight transference of the head and cervical region to the trunk. It is suggested that attaining FHP by individuals causes various mal-alignments whether pertaining to musculoskeletal, neurological, respiratory or behavioral abnormalities which may be a consequence of the adapted postures of individuals.

Objective: By far, there is no such study to treat various domains affected from FHP like musculoskeletal, balance, cognitive and vestibular cumulatively and comprehensively aiming to improve Cranio-vertebral angle and Quality of life of such individuals.

Methodology: This will be a multi-phased trial. Phase I will be a cross sectional study which will evaluate prevalence and correlation of FHP with other biomechanical lesion of the body. A total of 248 samples will be included in the study. Individuals between the age of 18 to 45 years will be recruited with the help of Purposive sampling. Phase II will be Feasibility study for protocol development and its Feasibility trial. Participants recruited in this phase will be chosen based on Purposive sampling. Phase III will be pre-test post-test Randomized Controlled trial.

Discussion: After the pandemic COVID-19, there have been a major increase in the risk and development of musculoskeletal ailments which are largely associated with lifestyle changes and activity cessation. This study will not only develop a treatment strategy for cases with Forward Head Posture but will also make sure that it does not stick over the Musculoskeletal discipline only. It will lead to researches being more focused over development of self-training and self-correcting strategies to combat Forward Head Posture during the initial phases of development of Forward Head Posture and will thus reduce the complications in future life.

Keywords: Balance, Cervical, Cognition, Forward Head Posture, Posture, Rehabilitation

 

 
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