| CTRI Number |
CTRI/2024/04/065107 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/03/2024 |
| 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
|
A comparison between group online sessions and individual online sessions for rehabilitating knee osteoarthritis patients in urban areas to see which one helps improve their quality of life better. |
|
Scientific Title of Study
|
Comparative Study of Group Live Session and Individual Live Session through Web Based Tele-Rehabilitation In Improving Quality of Life of Urban Population Patients with 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 |
Prof. (Dr) N.K. Singh |
| Designation |
Principal, Teerthanker Mahaveer Medical College & Research Centre |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Principal Office
Teerthanker Mahaveer Medical college building
Ground floor
Teerthanker Mahaveer University Delhi Road, Moradabad
Principal Office
Teerthanker Mahaveer Medical college building
Ground floor
Teerthanker Mahaveer University Delhi Road, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
09837848860 |
| Fax |
|
| Email |
principal.medical@tmu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. (Dr) N.K. Singh |
| Designation |
Principal, Teerthanker Mahaveer Medical College & Research Centre |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Principal Office
Teerthanker Mahaveer Medical college building
Ground floor
Teerthanker Mahaveer
Principal Office
Teerthanker Mahaveer Medical college building
Ground floor
Teerthanker Mahaveer
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
09837848860 |
| Fax |
|
| Email |
principal.medical@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Saurabh Agnihotri |
| Designation |
Senior Consultant Physiotherapist |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Physiotherapy OPD
Room no 1
Teerthanker Mahaveer Hospital
Delhi Road Moradabad
Physiotherapy OPD
Room no 1
Teerthanker Mahaveer Hospital
Delhi Road Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8938856863 |
| Fax |
|
| Email |
saurabh.mpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer University
Delhi Road
Moradabad, Uttarpradesh 244001 |
|
|
Primary Sponsor
|
| Name |
Saurabh Agnihotri |
| Address |
Teerthanker Mahaveer University |
| 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 |
| Saurabh Agnihotri |
Teerthanker Mahaveer Hospital |
Physiotherapy OPD
Teerthanker Mahaveer Hospital
Delhi Road
Moradabad
UTTAR PRADESH |
8938856863
saurabh.mpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| College Ethics Committee,TMU College of Paramedical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
knee osteoarthritis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group Telerehabilitation |
Web based Telerehabilitation will be given to knee osteoarthritic patients in group of four participants. |
| Comparator Agent |
Individual Telerehabilitation |
Web based Telerehabilitation will be given to knee osteoarthritic patients individually. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed knee osteoarthritis patients (Grade I, II, III)
2. Knee pain more than 3 months
3. Willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Subjects with Knee osteoarthritis Grade IV
2. Subjects having signs of hip osteoarthritis
3. Subjects using gait assistance device |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale
SF-36
WOMAC |
Visual Analogue Scale at baseline 3rd week and 6th week
SF-36 at baseline 3rd week and 6week
WOMAC at baseline 3rd week and 6 th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Physical activity readiness Questionnaire (PAR-Q)
Hamstring Flexibility Test
Quadriceps Flexibility Test
|
PAR-Q at baseline
Hamstring Flexibility Test at Baseline 3rd week and 6th week
Quadriceps Flexibility Test at baseline, 3rd week and 6th week |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
11/04/2024 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This is a comparative study to whose primary objective is to study the difference between effectiveness of group and individual live session through web based telerehabilitation in improving Quality of life in urban population patients with knee osteoarthritis. The null hypothesis state that there is no significant difference between effectiveness of Group live session and individual live session through web based telerehabilitation in improving Quality of life in urban population patients with knee osteoarthritis. The alternate hypothesis states that there is significant difference between effectiveness of Group live session and individual live session through web based telerehabilitation in improving Quality of life in urban population patients with knee osteoarthritis. |