| CTRI Number |
CTRI/2026/02/103305 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
07/02/2026 |
| 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
|
to see the Combined effect of restricted blood circulation to tissue and nerve ending training on strength and function in knee pain patients |
|
Scientific Title of Study
|
Combined FJfect of Blood Flow Restriction Training and Proprioceptive Training vs
Proprioceptive Training on Strength and Function - A Randomized 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 |
Dr Sanket Parekh |
| Designation |
Associate Professor |
| Affiliation |
k m Patel Institute of Physiotherapy |
| Address |
dept no 152 physiotherapy dept shree krishna hospital K M Patel Institute of Physiotherapy Shree Krishna Hospital Gokalnagar Karamsad
Anand
GUJARAT
388325
India |
| Phone |
09879352362 |
| Fax |
|
| Email |
sanketkp@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanket Parekh |
| Designation |
Associate Professor |
| Affiliation |
k m Patel Institute of Physiotherapy |
| Address |
dept no 152 physiotherapy dept shree krishna hospital K M Patel Institute of Physiotherapy Shree Krishna Hospital Gokalnagar Karamsad
GUJARAT
388325
India |
| Phone |
09879352362 |
| Fax |
|
| Email |
sanketkp@charutarhealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanket Parekh |
| Designation |
Associate Professor |
| Affiliation |
k m Patel Institute of Physiotherapy |
| Address |
K M Patel Institute of Physiotherapy Shree Krishna Hospital Gokalnagar Karamsad
GUJARAT
388325
India |
| Phone |
09879352362 |
| Fax |
|
| Email |
sanketkp@charutarhealth.org |
|
|
Source of Monetary or Material Support
|
| Dept no 152 physiotherapy dept shree krishna hospital K M patel Institute of Physiotherapy bhaikaka University karamsad 388 325 |
|
|
Primary Sponsor
|
| Name |
No Sponser |
| Address |
No sponser |
| Type of Sponsor |
Other [nil] |
|
|
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 Sanket Parekh |
Dept No 152 K M Patel Institute of Physiotherapy Shree Krishna Hospital Karamsad |
dept no 152 physiotherapy dept shree krishna hospital K M Patel Institute of Physiotherapy Shree Krishna Hospital Gokalnagar Karamsad
Anand
GUJARAT |
09879352362
sanketkp@charutarhealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee -2 Bhaikaka University Karamsad |
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 |
Blood FLow restriction therapy
|
pt is treated with applying tourniqute over the thigh region and then go for strengthening exercises |
| Intervention |
Proprioceptive training |
training works on stregnthening of muscles which help to improve the functions |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with knee osteoarthritis based on Kellgren-Lawrence grade 1-3 radiographic severity
patientst who are diagnosed with Primary knee Osteoarthritis
Experiencing knee pain for at less than 3 months.
Patients who are able to walk independenttly |
|
| ExclusionCriteria |
| Details |
Patient with systemic illness (infection, tumor, systemic inflammatory disease).
History of knee surgery (total knee replacement) in the past 6 months
Advanced knee osteoarthritis (Kellgren-Lawrence grade 4).
Any secondary causes for OA knee ((e.g., trauma, infection, inflammatory arthritis
Neurological deficits affecting lower limbs (neuropathy, stroke, multiple sclerosis
Acute trauma to the knee (ligament tear, fracture) in the past 6 month
Presence of inflammatory or autoimmune joint disease (rheumatoid arthritis, gout)
Cardiovascular contraindications to exercise or BFRT
Current use of corticosteroids, anticoagulants, or other medications that may interfere with exercise safety or muscle adaptation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WOMAC Questionnaire |
before commencing the exercises and after 2 weeks of interventions again outcome will be taken |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 RM strength of the muscle
Sensamove Mini Board |
pre exercises
then 2 weeks of exercise or intervention and then immediatly after 2 weeeks again outcome will be taken |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
23/02/2026 |
| 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
|
there are several treatment options foe treating the patients with knee pain but there are several other way to strengthen the muscles to prevent the pain and disability one of the technique is to controlled restrict the blood circulation so present study will help to improve the protocol for the strengthening of patient who are suffering from osteoarthrtities of knee |