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CTRI Number  CTRI/2025/08/093640 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 24/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Making a device for measuring the strength of neck muscles along with its movement in human beings 
Scientific Title of Study   Design Optimization And Development Of An Instrument Measuring Neck Muscle Function 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SGGSWU/IEC/2023/18  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Daman Preet Singh 
Designation  Ph.D. Scholar 
Affiliation  Sri Guru Granth Sahib World University 
Address  #3252 Sector 71 Mohali (SAS Nagar)
Department of Physiotherapy, Sri Guru Granth Sahib World University, Punjab-140407
Fatehgarh Sahib
PUNJAB
160071
India 
Phone  9872858169  
Fax    
Email  dpsingh1469@outlook.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pankajpreet Singh 
Designation  Associate Professor & HOD 
Affiliation  Sri Guru Granth Sahib World University 
Address  Department of Physiotherapy, Sri Guru Granth Sahib World University, Fatehgarh Sahib

Fatehgarh Sahib
PUNJAB
140407
India 
Phone  9781533615  
Fax    
Email  drpankajpreetsingh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pankajpreet Singh 
Designation  Associate Professor & HOD 
Affiliation  Sri Guru Granth Sahib World University 
Address  Department of Physiotherapy, Sri Guru Granth Sahib World University, Fatehgarh Sahib

Fatehgarh Sahib
PUNJAB
140407
India 
Phone  9781533615  
Fax    
Email  drpankajpreetsingh@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Daman Preet Singh 
Address  Department of Physiotherapy, Room No.8 Physiotherapy OPD Sri Guru Granth Sahib World University Fatehgarh Sahib, Punjab. Pin 140407 India 
Type of Sponsor  Other [Self] 
 
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 Pankajpreet Singh  Sri Guru Granth Sahib World University  Department of Physiotherapy, Room No.8 Physiotherapy OPD Sri Guru Granth Sahib World University
Fatehgarh Sahib
PUNJAB 
9781533615

drpankajpreetsingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Sri Guru Granth Sahib World University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal Healthy Individuals 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Normal individuals without any symptoms pain in the neck, shoulder, elbow, and wrist and any other condition that may compromise performance of a maximal isometric contraction of the cervical musculature; pain-free active flexion, extension, and side bending; in the last 6 months.

Negative Spurling compression test.  
 
ExclusionCriteria 
Details  Participants shall be excluded if they had any current neck pain or a history of cervical injury or any other associated condition that required medical care within the past 6 months and may impact the performance of the testing procedure or act as a contraindication to its performing 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Development of an instrument measuring neck muscle function  To check the clinimetrics’ standard of the developed instrument for neck muscle function. Best performance value out of the 03 Measured values in each case with the newly developed instrument measuring neck muscle function. It is a one time study (total 30 participants each taking approximately 15- 20 min)to be completed in 6 months. Normal participants will push the head contact area against the resistance and value will be checked. 3 attempts shall be made. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/09/2025 
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="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  

Neck pain is one of the most debilitating conditions for which patients seek medical and physiotherapy treatment. Cervical muscle function has been very often associated with the pathological factors and has been regarded as one of the important diagnostic and prognostic factors in the successful management of such patients afflicted with neck related painful conditions. Health professionals practicing physiotherapy, orthopaedics, neurology, etc., who advise and rehabilitate patients with neck related ailments often recommend neck range of motion and strengthening exercises for the neck muscles to alleviate the pain and improve neck muscle function. Accordingly, it is important to measure the baseline cervical muscle function in order to assess the deficits, plan and implement an effective exercise prescription with the scope to monitor progress at regular follow-ups.

However, the different dynamometers used to measure the isometric cervical muscle strength have different working principles, measured values and clinimetric properties, thus making it difficult to compare the results of one study with that of the other. Further, due to the exorbitant prices of fixed frame dynamometers and the inconsistent protocols of the hand-held dynamometers, their use in the routine clinical practice is limited only.

The study will help in the development of a valid and a reliable indigenous instrument to quantify the neck muscle function related parameters like, neck muscle strength and range of motion in different planes with a strong bio-measure protocol thereby, assisting the health professionals in prescribing an effective and more objective exercise regime with a scope to measure improvement over the rehabilitation phase.

 
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