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CTRI Number  CTRI/2025/02/081039 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 06/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Impact of Forward Head Posture on Ankle Joint strength and energy 
Scientific Title of Study   Impact of Forward Head Posture on Ankle Joint Torque and Power : A Correlational 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  Samta Gandhi 
Designation  Post Graduate Student 
Affiliation  KLE Institute of Physiotherapy 
Address  KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room no. 39, Sagar Floor, Advanced Physiotherapy Centre, Department of Biomechanics, Belgaum, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9549999154  
Fax    
Email  samtagandhi01@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Samta Gandhi 
Designation  Post Graduate Student 
Affiliation  KLE Institute of Physiotherapy 
Address  KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room no. 39, Sagar Floor, Advanced Physiotherapy Centre, Department of Biomechanics, Belgaum,Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9549999154  
Fax    
Email  samtagandhi01@gmail.com  
 
Details of Contact Person
Public Query  
Name  Samta Gandhi 
Designation  Post Graduate Student 
Affiliation  KLE Institute of Physiotherapy 
Address  KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room no. 39, Sagar Floor, Advanced Physiotherapy Centre, Department of Biomechanics, Belgaum,Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9549999154  
Fax    
Email  samtagandhi01@gmail.com  
 
Source of Monetary or Material Support  
KLEs Dr. Prabhakar Kore Hospital and Research Center, Nehru Nagar, Belagavi, Karnataka,590010, India 
 
Primary Sponsor  
Name  KLE Institute of Physiotherapy 
Address  KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room no. 39, Sagar Floor, Advanced Physiotherapy Centre, Department of Biomechanics, Belgaum, Karnataka 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Varsha Huddar  KLE Institute of Physiotherapy  KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room no. 39, Sagar Floor, Advanced Physiotherapy Centre, Department of Biomechanics, Belgaum, Karnataka
Belgaum
KARNATAKA 		 9880733370

varshahuddarklekipt@edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethical Committee KLE Institute of Physiotherapy   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Forward Head Posture 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Craniovertebral angle (CVA) lesser than or equal to 48°
2. All genders healthy individuals within 18-30 years age group 
 
ExclusionCriteria 
Details  1. Past or present history of injuries or surgeries within the cervical, thoracic and lumbar spine, head or upper and lower limb extremities, ; occurring
within the last six months.
2. Chronic Ankle Instability - Standard Inclusion Criteria, Endorsed, as a Minimum, by the International Ankle Consortium .
3. Congenital abnormality of spine, upper or lower limb.
4. Diagnosed cases of any structural abnormalities of spine, upper or lower limb.
5. Neurological disorders. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Craniovertebral angle  At one point, individuals will be screened for craniovertebral angle. 
 
Secondary Outcome  
Outcome  TimePoints 
The BTS SMART - DX 400 3D Gait Analysis Lab  At one point, individuals will be analyzed for ankle joint kinetic parameters. 
 
Target Sample Size   Total Sample Size="31"
Sample Size from India="31" 
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/03/2025 
Date of Study Completion (India) 20/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 20/03/2025 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Manuscript submitted to the journal, editors decision awaited. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [samtagandhi01@gmail.com].

  6. For how long will this data be available start date provided 02-06-2025 and end date provided 02-05-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The biomechanical relationships between the head, spine, and lower extremities make forward head posture a significant concern. Nowadays, young adults are more prone to using technologies for extended period of time. This technological diversity is leading the population in constant anterior movement of neck putting unwanted pressure on muscles of neck and upper back and hence causing forward head posture .

The purpose of the study is to investigate the impact of forward head posture on ankle joint torque and power. By analyzing these two key aspects, the study aims to determine the effect of reduced craniovertebral angle in individuals with forward head posture on ankle joint forces like torque and power .The findings could provide a valuable insight towards a holistic approach of assessment and treatment strategies for ankle or head and neck postural deviations. It might imply that improving the forward head posture could aid in improving the mechanics of the ankle joint. Additionally, this research may contribute to the evaluation of risk of skeletal and soft tissue injuries influenced by FHP on distal extremities.

This is an observational study which involves screening participants for forward head posture using craniovertebral angle measurement. Those falling under the inclusion criteria will be recruited for the study. After obtaining informed consent, participants will be asked to wear comfortable sports attire, have retroreflective markers placed on lower limb landmarks, and walk 10 meters. A 3D Gait analyzer will collect ankle moment and power data for statistical analysis. There will be less than minimal risk involved in the study. All the investigations will be performed under one-to-one supervision of the researcher.
 
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