| CTRI Number |
CTRI/2026/01/101054 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of knee mobilisation with strength training compared to strength training alone on quadriceps strength and functional performance in individuals with early knee osteoarthritis |
|
Scientific Title of Study
|
Effectiveness of knee mobilisation and strength training versus strength training alone on quadriceps strength and functional activity in early knee osteoarthritis: A randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sana Kuntoji |
| Designation |
Post graduate student |
| Affiliation |
BVV sanghas college of physiotherapy, Rajiv Gandhi University Health Sciences |
| Address |
BVV Sanghas College of Physiotherapy,Room no. 21, HSK hospital campus, Navanagar, Bagalkot, Karnataka 587103
Bagalkot
KARNATAKA
587103
India |
| Phone |
7349329712 |
| Fax |
|
| Email |
sanakuntoji369@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mahantesh Biradi |
| Designation |
Associate professor |
| Affiliation |
BVV sanghas college of physiotherapy, Rajiv Gandhi University of health sciences |
| Address |
BVV Sanghas College of Physiotherapy,Room no. 21, HSK hospital campus, Navanagar, Bagalkot, Karnataka 587103
Bagalkot
KARNATAKA
587103
India |
| Phone |
9964040848 |
| Fax |
|
| Email |
mahanteshbiradi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sana Kuntoji |
| Designation |
Post graduate student |
| Affiliation |
BVV sanghas college of physiotherapy, Rajiv Gandhi University of health sciences |
| Address |
BVV Sanghas College of Physiotherapy,Room no. 21, HSK hospital campus, Navanagar, Bagalkot, Karnataka 587103
Bagalkot
KARNATAKA
587103
India |
| Phone |
7349329712 |
| Fax |
|
| Email |
sanakuntoji369@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sana Kuntoji |
| Address |
BVV Sanghas College of Physiotherapy,Room no. 21, HSK hospital campus, Navanagar, Bagalkot, Karnataka 587103 |
| Type of Sponsor |
Other [self funded] |
|
|
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 Shreya Soakar |
Department of Physiotherapy, HSK Hospital Bagalkot |
BVV Sanghas College of Physiotherapy,Room no. 21, HSK hospital campus, Navanagar, Bagalkot, Karnataka 587103
Bagalkot
KARNATAKA |
9420026924
shreya22soakar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SNMC-institutional ethics committee on human subjects research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
Strength training exercise include static quadriceps in knee extension will be performed 10 sec holding 7 sec rest for 10 repetitions dynamic quadriceps with the resistance band will be performed 10 sec holding 7 sec rest for 10 repetitions wall squats will be performed for 10 repetitions standing leg curls will be performed for 10 repetitions VMO strengthening will be performed |
| Intervention |
Experimental group |
Mulligans mobilization with movement
medial glide MWM was performed for patients presenting with medial knee pain
lateral glide MWM was performed for patients present with lateral knee pain
Strength training exercise include static quadriceps in knee extension will be performed 10 sec holding 7 sec rest for 10 repetitions
dynamic quadriceps with the resistance band will be performed 10 sec holding 7 sec rest for 10 repetitions
wall squats will be performed
for 10 repetitions standing leg curls will be performed for 10 repetitions
VMO strengthening will be performed
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
knee OA diagnosed by practitioner/Orthopaedics
Tibiofemoral knee osteoarthritis on the basis of X-ray
Unilateral condition
American college of rhematology (ACR) criteria
Age of 35 to 50 years |
|
| ExclusionCriteria |
| Details |
Patient who are not willing to participate in the study
Bilateral knee OA
Patellofemoral knee OA
Malignancy
Infection to knee joint or knee bursa
Traumatic injury to knee joint |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
VAS(visual analogue scale)
WOMAC scale(Western Ontario and McMaster University Osteoarthritis Index)
Hand-held Dynamometer
|
outcome will be taken at baseline and 3 weeks post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
25/01/2026 |
| 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)
|
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
|
Aims To evaluate the efficacy of knee mobilization and strength training versus strength training alone on quadriceps strength and functional activity Objectives To evaluate the effects of IFT knee mobilization and strength training on quadriceps strength using hand held dynamometer functional activity using the WOMAC scale and pain levels measured using the visual analogue scale in subject with early knee OA in the experimental group To evaluate the effects of IFT strength training on quadriceps strength using hand held dynamometer functional activity using the WOMAC scale and pain levels measured using the visual analogue scale in subject with early knee OA in the controlled group To compare the efficacy of IFT knee mobilization and strength training versus strength training and IFT between the two intervention groups Methods of Randamization A total 86 early knee OA patients on basis of simple random sampling will be assigned into two groups Group A will receive strength training exercises IFT and Group B will receive IFT knee joint mobilization and strength training Methodology Patient will be assessed and screened according to inclusion and exclusion criteria A brief explanation of the study process will be given Consent will be obtained from those who agree to participate Patient will be assigned into either of the groups by simple random sampling Pretest baseline data will be assembled using VAS WOMAC and Hand held dynamometer The intervention will be given in one to one participants The intervention will be given for three consecutive days in a week for 3 week continuously treatment session will be around 45 to 60 minutes Pre and Post treatment scores on VAS WOMAC scale and Hand held dynamometer will be analyzed statistically to determine the effectiveness of each intervention and compare outcomes between the two groups |