| CTRI Number |
CTRI/2025/04/085816 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Reliability and Validity Study |
| Study Design |
Other |
|
Public Title of Study
|
A novel Low-cost Force Measurement System for Muscle strength Assessment of Quadriceps and Hamstrings Muscle among Healthy Young Adults |
|
Scientific Title of Study
|
Development and testing of a Low-cost Continuous Force Measurement System (CFMS) for Quadriceps and Hamstrings Muscle Strength among Healthy Young Adults |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vivek Harsukhbhai Ramanandi |
| Designation |
Associate Professor |
| Affiliation |
SPB Physiotherapy College |
| Address |
Room No. 2,
Dept of Neurological Physiotherapy,
SPB Physiotherapy OPD,
Mora Bhagal,
Ugat-Bhesan Road,
Rander Road,
Surat
Surat
GUJARAT
395005
India |
| Phone |
7878585656 |
| Fax |
|
| Email |
vivekramanandi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vivek Harsukhbhai Ramanandi |
| Designation |
Associate Professor |
| Affiliation |
SPB Physiotherapy College |
| Address |
SPB Physiotherapy College
Room No.2,
Dept of Neurological Physiotherapy,
OPD No.2,
Ugat-Bhesan Road,
Rander Road,
Mora Bhagal,
Surat-395005
Surat
GUJARAT
395005
India |
| Phone |
7878585656 |
| Fax |
|
| Email |
vivekramanandi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vivek Harsukhbhai Ramanandi |
| Designation |
Associate Professor |
| Affiliation |
SPB Physiotherapy College |
| Address |
SPB Physiotherapy College
Room No.2,
Dept of Neurological Physiotherapy,
OPD No.2,
Ugat-Bhesan Road,
Rander Road,
Mora Bhagal,
Surat-395005
Surat
GUJARAT
395005
India |
| Phone |
7878585656 |
| Fax |
|
| Email |
vivekramanandi@gmail.com |
|
|
Source of Monetary or Material Support
|
| SPB Physiotherapy College, Ugat-Bheasn Road,
Rander Road,
Mora Bhagal,
Surat-395005 |
| UGC Cell, Veer Narmad Southe Gujarat University.
Funding on Behalf of UGC. |
|
|
Primary Sponsor
|
| Name |
Vivek Harsukhbhai Ramanandi |
| Address |
SPB Physiotherapy College
Ugat-Bheasn Road,
Rander Road,
Mora Bhagal,
Surat-395005
|
| Type of Sponsor |
Other [Individual] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SPB Physiotherapy College |
Ugat-Bheasn Road,
Rander Road,
Mora Bhagal,
Surat-395005 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vivek Harsukhbhai Ramanandi |
SPB Physiotherapy College |
OPD Room No.2,
Dept of Neurological Physiotherapy,
Ugat-Bhesan Road,
Rander Road,
Mora Bhagal,
Surat-395005
Surat
GUJARAT |
7878585656
vivekramanandi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of SPB Physiotherapy College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
The study is not required to be conducted upon any specific medical condition as it is a validation study for a device to assess muscle strength in health human volunteer participants. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy adults willing to sign informed consent.
2. Gender: Male and female.
3. Age group: 18-25 years.
|
|
| ExclusionCriteria |
| Details |
1. Individuals with any musculo-skeletal or neuro-muscular disorder which may affect the test performance for strength evaluation;
2. Individuals having recent history of injury or surgery in lower extremities;
3. Individuals having any significant medical/ surgical disease or disorder which may affect perceptual, cognitive, mental, or neuromuscular aspects of individual well-being.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of CFMS based muscle strength and force production with the Strength of Quadriceps and Hamstrings Muscles using Hand-held Electronic Dynamometer (HHD); Maximal Voluntary Contraction ability of Quadriceps and Hamstrings using Surface electromyography (sEMG) |
Outcomes will be evaluated once at the time of visit of the participant as the study is of cross-sectional design. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
02/06/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study aims to develop and validate a low-cost Continuous Force Measurement System (CFMS) for assessing quadriceps and hamstrings muscle strength in healthy young adults aged 18–25 years. The study addresses the limitations in current methods of strength assessment such as high cost and limited accessibility of commercial dynamometers, especially in developing countries, by designing an affordable alternative suitable for both educational and clinical use. The project involves two phases: the first focuses on the design and development of the CFMS, while the second evaluates its reliability and validity against established methods such as hand held dynamometry and surface electromyography (sEMG). The outcomes are expected to demonstrate that the CFMS may provide an accurate, reliable, and cost-effective alternative for muscle strength measurements, supporting its adoption in physiotherapy education and practice. |