| CTRI Number |
CTRI/2026/02/104806 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Shoe Inserts and proprioceptive exercises on Knee Osteoarthritis |
|
Scientific Title of Study
|
Effectiveness Of Lateral Wedge Insole and Proprioceptive Exercises In Patients With Medial 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 |
Alka Yadav |
| Designation |
MPT Student |
| Affiliation |
Guru Jambheshwar University Hisar Haryana India 125001 |
| Address |
Room no. 4-5 Department Of Physiotherapy Guru Jambheshwar University Of Science and Technology Hisar Haryana India 125001
Room no. 4-5 Department Of Physiotherapy Guru Jambheshwar University Of Science and Technology Hisar Haryana India 125001
Hisar
HARYANA
125001
India |
| Phone |
7082178543 |
| Fax |
|
| Email |
alka13158@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Sabharwal |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University Hisar Haryana India 125001 |
| Address |
Department Of Physiotherapy Guru Jambheshwar University Of Science and Technology Hisar Haryana India 125001
Department Of Physiotherapy Guru Jambheshwar University Of Science and Technology Hisar Haryana India 125001
Hisar
HARYANA
125001
India |
| Phone |
941665373 |
| Fax |
|
| Email |
jyotisabharwal35@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Alka Yadav |
| Designation |
MPT Student |
| Affiliation |
Guru Jambheshwar University Hisar Haryana India 125001 |
| Address |
Room no. 4-5 Department Of Physiotherapy Guru Jambheshwar University Of Science and Technology Hisar Haryana India 125001
Department Of Physiotherapy Guru Jambheshwar University Of Science and Tecchnology Hisar Haryana India 125001
Hisar
HARYANA
125001
India |
| Phone |
07082178543 |
| Fax |
|
| Email |
alka13158@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alka Yadav MPT Student Department Of Physiotherapy Guru Jambheshwar University Of Science And Technology Hisar Haryana India 125001 |
|
|
Primary Sponsor
|
| Name |
Department Of Physiotherapy |
| Address |
Guru Jambheshwar University Hisar Haryana India 125001 |
| Type of Sponsor |
Research institution |
|
|
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 Jyoti sabharwal |
Guru Jambheshwar University of Science and Technology |
Room no.5 Department Of Physiotherapy OPD GJUS&T Hisar Haryana India 125001
Hisar
HARYANA |
941665373
jyotisabharwal35@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional treatment (hotpack & ultrasound therapy ) |
patients in this group will recieve coventional treatment for 3 days in a week for 6 weeks |
| Intervention |
Lateral Wedge Insoles and conventional treatment
|
Patients in this group will recieve Lateral Wedge Insoles and conventional treatment for3 daysin a week for 6 weeks |
| Intervention |
Proprioceptive Exercises and conventional treatment
|
Patients in this group will recieve Proprioceptive Exercises and conventional treatment for 3 days in a week for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
42.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Both male &female
Age 42-70
Kellgren /Lawrence grade (2&3)
Medial knee osteoarthritis
Patients with bilateral knee osteoarthritis
|
|
| ExclusionCriteria |
| Details |
Patient use assistive device
Knee joint trauma
History of knee joint surgeries
Previous joint replacement in lower limb
Cardiovascular disease
Chronic kidney disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual analog scale (VAS)
Romberg test
6 min walk test
Western Ontario and mcmaster universities osteoarthritis index (WOMAC)
|
Base line Intervention
Post Intervention: on alternate days for 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
10/03/2026 |
| 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="0"
Months="7"
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
|
The selection criteria will be applied when screening the participants. Written informed consent will be acquired from those who meet the selection criteria following a thorough description of the study’s protocol. The patients are divided into 3 groups (Group A, Group B, and Group C). Before the intervention begins, baseline data for each outcome measure will be gathered from every participant. At six weeks, post-intervention data will be gathered. For six weeks, treatment will be administered 3 times a week.
PROTOCOL
GROUP A: Lateral wedge insoles and conventional treatment (hot pack and ultrasound therapy )
GROUP B: Proprioceptive exercises and conventional treatment ( hot pack and ultrasound therapy )
GROUP C: Conventional treatment (hot pack and ultrasound therapy ) |