| 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
|
|
|
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
|
|
|
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
|
|
|
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. |