| CTRI Number |
CTRI/2024/01/061669 [Registered on: 19/01/2024] Trial Registered Prospectively |
| Last Modified On: |
11/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy of Electronic Exercise In Management Of Knee Osteoarthritis |
|
Scientific Title of Study
|
Efficacy of E- Exercise In Management Of 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 |
Dr. Lavi Jain |
| Designation |
Student |
| Affiliation |
Amity Institute Of Health Allied Sciences |
| Address |
F-1 Block LGF Amity Institute Of Health Allied Sciences Amity University
Sector125 Noida - 201303 Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
9910180432 |
| Fax |
|
| Email |
jainlavi.28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pragya |
| Designation |
Assistant Professor |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Room No. - 107A First floor Amity Institute Of Health Allied Sciences Amity University
Sector-125 Noida - 201303 Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
09878529787 |
| Fax |
|
| Email |
pkumar24@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragya |
| Designation |
Assistant Professor |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Room No. - 107A First Floor Amity Institute Of Health Allied Sciences Amity University
Sector-125 Noida- 201303 Uttar Pradesh India
UTTAR PRADESH
201303
India |
| Phone |
09878529787 |
| Fax |
|
| Email |
pkumar24@amity.edu |
|
|
Source of Monetary or Material Support
|
| F1 block LGF
Amity Institue Of Health Allied Sciences Amity University sector 125 Noida 201303 Uttar Pradesh India |
|
|
Primary Sponsor
|
| Name |
Dr Lavi Jain |
| Address |
F- 1 Block LGF Amity Institute Of Health Allied Sciences Amity University
Sector-125 Noida 201303 Uttar Pradesh India |
| 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 Lavi Jain |
Jeevan Sayog Welfare Foundation |
Jeevan Sayog Welfare Foundation
Block F Room no. 1 Krishna nagar, Delhi -110051
East
DELHI |
9910180432
jainlavi.28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Amity University,Noida |
Approved |
| Jeevan Sayog Welfare Foundation |
No Objection Certificate |
|
|
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 |
Physiotherapy Exercise Protocol for Osteoarthritis Patient |
In this study we will include 40 participants suffering from knee osteoarthritis of age above 40 ,20 participants in each group with usual physiotherapy treatment to one group while E Exercise to other groups. The Primary outcome will include pain severity, functional status and patient satisfaction level.
4-Week Training Protocol Dosimetry :
The protocol to be followed for 4 weeks and the exercises to be done in sets of 2 with 10 repetitions in each set for 45 minutes.
Dosage:
2 sets with 10 repetitions and 3 days a week, Hot Pack for 15 mins before exercise
Exercises :
Isometric Quadricep
Isometric Hamstring
Bridging exercise
Step up and step down
Sit to Stand
Calf Raise
Wall Squat
hamstring stretch |
| Comparator Agent |
Supervised group ( usual care group) |
This group is provided with physiotherapy session conducted face to face in clinic (supervised exercise).The Primary outcome will include pain severity, functional status and patient satisfaction level. 4-Week Training Protocol Dosimetry : The protocol to be followed for 4 weeks and the exercises to be done in sets of 2 with 10 repetitions in each set for 45 minutes. Dosage: 2 sets with 10 repetitions and 3 days a week, Hot Pack for 15 mins before exercise Exercises : Isometric Quadricep Isometric Hamstring Bridging exercise Step up and step down Sit to Stand Calf Raise Wall Squat hamstring stretch |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Usual Care Group
All Patients Having Knee
OA ( Grade 2 &3)
( Kellgren- Lawrence
classification)
- Above 40 – 60 years of age
- Both males and female
E-Exercise Group
- All Patients Having Knee OA
- Above 40 years of age
- Both males and female
patients
- Should have proper internet
connection
|
|
| ExclusionCriteria |
| Details |
- All Patients Having Knee OA
( stage 2&3)
- Above 40 years of age
- Both males and female patients
- Should have proper internet connection
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Numeric Pain Rating Scale (NPRS)
2. WOMAC Osteoarthritis Index
|
After 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Patient Satisfaction Questionnaire |
After 1 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
23/01/2024 |
| 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="0"
Days="30" |
|
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 main purpose of the study is to evaluate the effectiveness of E-exercise in knee osteoarthritis and to compare the effect of E-Exercise with supervised exercise in treatment of Knee Osteoarthritis patients
It is an intervention study. The study will include 40 patients of knee osteoarthritis of age 40-60 years. They will further divided into two groups based on the mode of treatment applied that is online mode (exercise) or session conducted face to face in clinic (supervised exercise). Then they will provided with physiotherapy intervention to check the effectiveness of e exercise. Numeric pain rating scale, WOMAC Osteoarthritis Index and patient satisfaction questionnaire are used to evaluate the pain, physical function and patient satisfaction. The data will be analyzed at the end of the study. |