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CTRI Number  CTRI/2025/09/094096 [Registered on: 02/09/2025] Trial Registered Prospectively
Last Modified On: 01/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Age and gender-wise comparison of normative cervical range of motion in individuals aged between 18-40 years 
Scientific Title of Study   Estimation and age and gender-wise comparison of normative cervical range of motion using cervical range of motion (CROM) device and measure tape method in asymptomatic individuals aged between 18-40 years: A cross-sectional 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  Smriti Sudhir Ghatge 
Designation  Post Graduate Student 
Affiliation  D Y Patil deemed to be University, School of Physiotherapy 
Address  D Y Patil deemed to be University, School of Physiotherapy, Department of Musculoskeletal Physiotherapy, 6th Floor, Plot No-2. Sector 5, Nerul, Navi Mumbai- 400706

Mumbai
MAHARASHTRA
400706
India 
Phone  9930926601  
Fax    
Email  smritisghatge@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Twinkle Dabholkar 
Designation  Professor and Head of Department of Musculoskeletal Physiotherapy 
Affiliation  D Y Patil deemed to be University, School of Physiotherapy 
Address  Y Patil deemed to be University, School of Physiotherapy, Department of Musculoskeletal Physiotherapy, 6th Floor, Plot No-2. Sector 5, Nerul, Navi Mumbai- 400706

Mumbai
MAHARASHTRA
400706
India 
Phone  9819870821  
Fax    
Email  twinkle.dabholkar@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Dr Twinkle Dabholkar 
Designation  Professor and Head of Department of Musculoskeletal Physiotherapy 
Affiliation  D Y Patil deemed to be University, School of Physiotherapy 
Address  Y Patil deemed to be University, School of Physiotherapy, Department of Musculoskeletal Physiotherapy, 6th Floor, Plot No-2. Sector 5, Nerul, Navi Mumbai- 400706

Mumbai
MAHARASHTRA
400706
India 
Phone  9819870821  
Fax    
Email  twinkle.dabholkar@dypatil.edu  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  D Y Patil deemed to be University, School of Physiotherapy 
Address  D Y Patil deemed to be University, School of Physiotherapy 6th Floor, Plot No-2. Sector-5, Nerul, Navi Mumbai-400706 
Type of Sponsor  Other [D Y Patil deemed to be University, School of Physiotherapy] 
 
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 
Smriti Ghatge  D Y Patil deemed to be University, School of Physiotherapy   D Y Patil deemed to be University, School of Physiotherapy 6th Floor, Plot No-2. Sector-5, Nerul, Navi Mumbai-400706
Mumbai
MAHARASHTRA 		 9930926601

smritisghatge@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) for Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  nil 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Asymptomatic individuals
2.Individuals who willing to participate in the study
3.Individuals aged between 18-40 years
4.Both male and females

 
 
ExclusionCriteria 
Details  1.Individuals with neck, upper back and shoulder pain
2.History of any spinal surgery
3.Individuals with Cervicogenic headache
4.Infective and Inflammatory conditions affecting the spine
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Cervical Range Of Motion Device (CROM device) and Measure tape  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)  15/09/2025 
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  

Title

Estimation and age and gender-wise comparison of normative cervical range of motion using cervical range of motion (CROM) device and measure tape method in asymptomatic individuals aged between 18-40 years: A cross-sectional study

Rationale

Previous studies demonstrated that youngest population have the greatest mobility compared to the older population. Females generally have greater cervical range of motion than males, and individuals aged 20–29 show the highest mobility with no significant age-related differences. However, individuals in the age group of 30-39 years demonstrated significant reductions in cervical motion as compared to 20–29-year-old individuals. Compared to women, males in their 30s and 40s had less mobility, whereas gender wise comparison revealed no differences in 20–29-year-old individuals. However, most of these studies are conducted in Western and other populations and have limited generalisability to our population due to differences in ethnicity, body proportions, cultural and other factors. Hence, using both the cervical range of motion device and the measuring tape method, this study aims to determine normative values for cervical range of motion and investigate if age and gender differences exist in the Indian population.

Aims and Objectives

Aim of the study:

To estimate and conduct an age and gender-wise comparison of normative cervical range of motion using cervical range of motion (CROM) device and measure tape method in asymptomatic individuals aged between 18-40 years.

Objectives of the study:

Primary objectives:

1.     To compare gender differences for cervical range of motion using cervical range of motion (CROM) device and measure tape method in asymptomatic healthy individuals aged between 18-29 years and 30-40 years of age.

2.     To compare age differences for cervical range of motion using cervical range of motion (CROM) device and measure tape method in asymptomatic healthy individuals aged between 18-29 years and 30-40 years of age.

       Secondary objectives:

1.     To determine normative values of cervical range of motion using cervical range of motion (CROM) device and measure tape method in asymptotic individuals aged between 18-29 years of age.

2.     To determine normative values of cervical range of motion using cervical range of motion (CROM) device and measure tape method in asymptotic individuals aged between 30-40 years of age.

 

Materials and Methodology

Study tools/materials:

1.     Measure tape

2.     Cervical range of motion (CROM) device

3.     Skin marking pencil/pen

4.     Chair/stool

Measure tape method

Cervical flexion: Mark the midpoint of the chin tip and the lower edge of the sternal notch using a skin marking pencil. Measure the distance between the mark at the lower edge of the sternal notch and the mark on the tip of the chin at the end of the range of motion. Ensure that that individual’s mouth stays closed throughout the movement.

Cervical extension: Mark the midpoint of the chin tip and the lower edge of the sternal notch using a skin marking pencil. Measure the distance between the mark at the lower edge of the sternal notch and the mark on the tip of the chin at the end of the range of motion. Ensure that the individual’s mouth stays closed throughout the movement.

Cervical lateral flexion: Mark the individual’s mastoid process and the lateral tip of the acromial process with a skin marking pencil. Ask the individual to move their head towards the shoulder. Do not allow the head to rotate, forward flex, or extend during the motion. At the end of cervical lateral flexion range of motion, measure the distance between the two markings.

Cervical rotation: Mark the acromial process and the tip of the chin with a skin marking pencil. Ask the individual to stare directly ahead before turning their head as far to the right or left side without turning their trunk. At the end of the range of motion, measure the distance between the two markings.

Cervical range of motion device

Two gravity inclinometers and a compass inclinometer are supported by the headpiece of the CROM device. In order to measure flexion and extension, a single gravity inclinometer is situated on the side of the head in the sagittal plane. The other gravity inclinometer is used to measure lateral flexion and is situated in the frontal plane above the forehead. The compass inclinometer, which measures rotation, is placed over the top of the head in the transverse plane and features a gravity needle. To guarantee accuracy, a neckpiece with two powerful magnets is positioned around the individual’s neck when using the compass inclinometer.

The CROM device should be carefully placed on the head of the individual so that the Velcro strap fits firmly over the back of the head and the nosepiece rests on the nose bridge. The device is universally applicable, and obtaining a good fit is quite simple for an examiner. Make sure the head is positioned such that the inclinometer on the side reads 0 degree.

 Cervical flexion: Ask the individual to gently move their head forward while keeping their trunk straight. Check the inclinometer’s dial on the side of the head at the end of the range of the motion, then note the result.

Cervical extension: Ask the individual lift their chin and then bend their head back as far as they can until they encounter resistance. After the movement is complete, record the result by reading the dial on the inclinometer on the side of the head.

Cervical lateral flexion: Ask the person to tilt their head sideways without turning, extending, or moving their head forward. At the end of the movement, note the number of degrees on the dial in front of the forehead.

Cervical rotation: Position the CROM device on the individual’s head such that the nosepiece rests on the nose bridge. The magnetic yoke should be placed over the individual’s shoulders with the arrow facing north. Adjust the individual’s head such that both gravity inclinometers read 0 degrees to make sure the compass inclinometer is level. Make sure the compass inclinometer is level, then adjust the rotation meter until the pointer is zero degrees.

Tell the individual to look directly ahead and to turn their chin as much towards their shoulder as they can without bending it laterally, forward, or backward. Keep your shoulders loose, then read the inclinometer that rests over it when the movement is complete.



 

 

 

 

 

 
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