| CTRI Number |
CTRI/2025/07/092007 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing the Reliability of Pressure Biofeedback for Measuring Gastrocnemius Muscle Activity in Adults with Knee Osteoarthritis |
|
Scientific Title of Study
|
Establishing Test-Retest Reliability of Pressure Biofeedback in Measuring Gastrocnemius Muscle Activation in Adults with Bilateral Knee Osteoarthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yashasvi Parmar |
| Designation |
MPT Student |
| Affiliation |
MMIPR, Maharishi Markandeshwar (Deemed to be University) |
| Address |
First Floor, Physiotherapy Department, MMIPR, Maharishi Markandeshwar (Deemed to be University),
Mullana
Ambala HARYANA 133207 India |
| Phone |
8427357220 |
| Fax |
|
| Email |
yashasvi22parmar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sunita Sharma |
| Designation |
Professor |
| Affiliation |
MMIPR, Maharishi Markandeshwar (Deemed to be University) |
| Address |
First Floor, Physiotherapy Department, MMIPR, Maharishi Markandeshwar (Deemed to be University),
Mullana
Ambala HARYANA 133207 India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Sunita Sharma |
| Designation |
Professor |
| Affiliation |
MMIPR, Maharishi Markandeshwar (Deemed to be University) |
| Address |
First Floor, Physiotherapy Department, MMIPR, Maharishi Markandeshwar (Deemed to be University),
Mullana
Ambala HARYANA 133207 India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Orthopedic Physiotherapy Research Laboratory, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University),
Mullana-Ambala, Haryana, 133207 |
|
|
Primary Sponsor
|
| Name |
Yashasvi Parmar |
| Address |
First Floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University),
Mullana-Ambala, Haryana, 133207 |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sunita Sharmar |
First Floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University),
Mullana-Ambala, Haryana, 133207 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Yashasvi Parmar |
MMIPR Physiotherapy OPD |
First Floor, Physiotherapy Department, MMIPR, Maharishi Markandeshwar (Deemed to be University),
Mullana Ambala HARYANA |
8427357220
yashasvi22parmar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee, Maharishi Markandeshwar Institute of Medical Science and Research, Mullana-Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M172||Bilateral post-traumatic osteoarthritis of knee, (2) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (3) ICD-10 Condition: M174||Other bilateral secondary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than 50-80 years
2. Both male and female
3. Knee OA Grade I, II, and III based on the Kellgren and Lawrence grading system
4. A patient who can follow simple verbal commands
|
|
| ExclusionCriteria |
| Details |
1. Knee Osteoarthritis Grade IV based on the Kellgren and Lawrence grading system
2. Injuries surrounding the gastrocnemius muscle
3. Any recent injury or surgery
4. History of neurological conditions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pressure Biofeedback Unit |
Baseline and 48 hours later (i.e. 2 days later) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="104" Sample Size from India="104"
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)
|
11/08/2025 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Osteoarthritis (OA) is a prevalent degenerative joint disorder that commonly affects the knee joint, leading to pain, stiffness, and functional limitations in adults. Among the muscles involved in knee function, the gastrocnemius plays a crucial role in knee flexion and ankle plantarflexion, contributing significantly to mobility and balance. Hence, the accurate measurement of gastrocnemius muscle activation is essential for understanding its role in managing OA symptoms and developing targeted rehabilitation interventions. Pressure biofeedback devices, traditionally used for muscle activation, offer a non-invasive method to measure muscle activity during specific tasks or exercises. In OA patients, the variability in muscle function due to pain, inflammation, and compensatory patterns makes using a tool that provides dependable and repeatable results crucial. However, for the pressure biofeedback tool to be a reliable measure of gastrocnemius muscle activation in symptomatic OA adults, its test-retest reliability must be established. This research aims to study the test-retest reliability of the pressure biofeedback unit in measuring gastrocnemius muscle activation while performing the isometric gastrocnemius contraction in long sitting. It is a single-group Cross-Sectional Study. Participants will be recruited based on inclusion and exclusion criteria. The participants will complete the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scale to assess the baseline severity of their symptoms, including pain, stiffness, and functional limitations. Following this, they will perform gastrocnemius contraction in a long sitting position under the supervision of a trained physiotherapist. Baseline data on gastrocnemius muscle activation will be collected using a pressure biofeedback unit to measure changes in pressure as an indicator of muscle activation. Participants will then return 48 hours later to perform the gastrocnemius contraction in long sitting again under the same conditions, and the measurements will be repeated to evaluate the test-retest reliability of the device. Efforts will be made to maintain consistency across both sessions by providing standardized instructions and using the same equipment setup. |