| CTRI Number |
CTRI/2024/09/073209 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial on Effect of BFRT on muscle activity of vastus medialis oblique muscle in knee osteoarthritis population. |
|
Scientific Title of Study
|
Effect of Blood Flow Restriction Training on Muscle Activity of Vastus Medialis Obliques Muscle in Knee Osteoarthritis Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepshikha |
| Designation |
MPT Musculoskeletal Student |
| Affiliation |
Banarsidas Chandiwala Institute of Physiotherapy |
| Address |
Musculoskeletal Physiotherapy department, Chandiwala Estate, Maa Anandmai Marg, Kalkaji, New Delhi-110019
South West
DELHI
110019
India |
| Phone |
7547800277 |
| Fax |
|
| Email |
shikhadeep056@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niti Khurana PT |
| Designation |
Assistant Professor |
| Affiliation |
Banarasidas Chandiwala Institute of Physiotherapy |
| Address |
Musculoskeletal Physiotherapy Department,Chandiwala Estate, Maa Anandmai Marg, Kalkaji, New Delhi-110019
South West
DELHI
110019
India |
| Phone |
9811052132 |
| Fax |
|
| Email |
nitikhurana@bcip.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prithvi Parasher PT |
| Designation |
Assistant Professor |
| Affiliation |
Banarasidas Chandiwala Institute of Physiotherapy |
| Address |
Musculoskeletal Physiotherapy Department, Chandiwala Estate, Maa Anandmai Marg, Kalkaji, New Delhi-110019
South West
DELHI
110019
India |
| Phone |
9625603419 |
| Fax |
|
| Email |
prithvi@bcip.ac.in |
|
|
Source of Monetary or Material Support
|
| Banarsidas Chandiwala Institute of Physiotherapy, Musculoskeletal Physiotherapy Department,Chandiwala Estate, Maa Anandmai Marg, Kalkaji, New Delhi-110019, India |
|
|
Primary Sponsor
|
| Name |
Deepshikha |
| Address |
Chandiwala Estate, Maa Anandmayee Marg, near govindpuri, Shyam Nagar, Kalkaji, New Delhi, Delhi 110019 |
| Type of Sponsor |
Other [Self] |
|
|
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 Niti Khurana |
Banarsidas Chandiwala Institute of Physiotherapy |
Musculoskeletal Physiotherapy Department, Chandiwala Estate, Maa Anandmayee Marg, Shyam Nagar, Kalkaji, New Delhi, Delhi 110019
South West
DELHI |
9811052132
nitikhurana@bcip.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banarsidas Chandiwala Institute of Physiotherapy Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blood Flow Restriction Training |
Blood Flow Restriction Training (BFRT) may effectively mix moderate mechanical stress with high training intensity, resulting in identical muscle mass growth and maintenance as standard high-load resistance training. The frequency of treatment is 3 times in a week. the protocol call is for 4 weeks. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
An instance of osteoarthritis in the knee with a clinical diagnosis of Grade 2,3.
There will be participants who are both male and female.
|
|
| ExclusionCriteria |
| Details |
Participants with any systematic illness like cancer, high blood pressure, any kind of neurological conditions, cardiovascular disease.
Participants with any recent knee injury or surgery.
Participants planned for total knee replacement.
Participants involved in any other exercise protocol. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The patient who are clinically diagnosed with grade 2,3 of knee osteoarthritis. |
3 times per week for 4 weeks. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
09/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
09/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
Osteoarthritis (OA) is primarily characterized by the degeneration of joint cartilage and changes in the underlying bone. Blood flow in the context of osteoarthritis refers to the circulation of blood to the affected joints and surrounding tissues. Blood flow restriction training in the context of osteoarthritis involves a specialized application of this technique for individuals with OA. It aims to improve muscle strength and function without subjecting the joints to excessive load. The aim is to study the effect of blood flow restriction training on EMG activity of vastus medialis oblique muscle in knee osteoarthritis patient. Sample size-30. Patients will be involved in the study from New Delhi. |