| CTRI Number |
CTRI/2024/05/067455 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| 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
|
How Telerehabilitation helps ease chronic knee osteoarthritis |
|
Scientific Title of Study
|
Efficacy of telerehabilitation in the management of chronic osteoarthritis knee |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Subba |
| Designation |
Student |
| Affiliation |
The Oxford College Of Physiotherapy |
| Address |
6/9, 1st Cross, Begur road, Near Kavya Hospital, Hongasandra, Bengaluru, Karnataka,
Physiotherapy Department, Ground Floor, Room 1
Bangalore
KARNATAKA
560068
India |
| Phone |
9972599380 |
| Fax |
|
| Email |
priyankasubba31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R V Vijay Kumar |
| Designation |
Assistant Professor |
| Affiliation |
The Oxford College Of Physiotherapy |
| Address |
6/9, 1st Cross, Begur road, Near Kavya Hospital, Hongasandra, Bengaluru, Karnataka,
Physiotherapy Department, Ground Floor, Room 1
Bangalore
KARNATAKA
560060
India |
| Phone |
09448482319 |
| Fax |
|
| Email |
rvvijay1976@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Vasanthan |
| Designation |
Principal |
| Affiliation |
The Oxford College of Physiotherapy |
| Address |
6/9, 1st Cross, Begur road, Near Kavya Hospital, Hongasandra, Bengaluru, Karnataka,
Physiotherapy Department, Ground Floor, Room 1
Bangalore
KARNATAKA
Principal
India |
| Phone |
09916919685 |
| Fax |
|
| Email |
physiotherapyprincipal@theoxford.edu |
|
|
Source of Monetary or Material Support
|
| The Oxford clinic and Rehabilitation centre, Bangalore, 560068 |
| The OXford Medical college, Hospital and Research centre, Anekal, Bangalore, India, 562107 |
| Zelus Physiotherapy, Hsr Layout, Bangalore, India , 560102 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyanka Subba |
The Oxford Medical College, Hospital and Research Centre |
Yadavanahalli, Attibele, Bengaluru-Chennai Hwy, Rajajinagar 3rd Block, Anekal, Karnataka 562107
Physiotherapy Department, Division 1
Bangalore
KARNATAKA |
9972599380
priyankasubba31@gmail.com |
| Dr Priyanka Subba |
The Oxford physiotherapy clinic and rehabilitation centre |
6/9, 1st cross, Begur road, Near Kavya Hospital, Hongasandra, Bengaluru, Karnataka
Physiotherapy Department, Room 1
Bangalore
KARNATAKA |
9972599380
priyankasubba31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Oxford College of Physiotherapy Review Board for Ethics and Research |
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 |
| Comparator Agent |
Conventional therapy |
Standardized exercises for Osteoarthritis knee
Exercises of 2 sets of 10 repetition
Duration 4 weeks |
| Intervention |
Telerehabilitation
|
through Zoom meeting
Exercises of 2 sets of 10 repetition
Duration 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Subjects having smart phones with internet connection
Subjects with chronic osteoarthritis based on Kellgren classification |
|
| ExclusionCriteria |
| Details |
Subjects with any other orthopedic disorder apart from osteoarthritis
Subjects with any visual deficits
Subjects with aphasia
Subjects who cannot read and write
Subjects with any neurological or cardiac conditions. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Western Ontario and MCMaster Universities Osteoarthritis Index
Numerical Pain Rating Scale
36-item Short Form Survey |
o week and 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient global impression of change |
0 week and 4th Week |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/05/2024 |
| 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="5"
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
|
Background: The COVID-19 pandemic has highlighted the importance of prioritizing safe and convenient healthcare delivery, leading to the rise of telehealth in physiotherapy. Telehealth offers increased access to care for patients with mobility issues by allowing them to receive physiotherapy services from their own homes, saving time and money. however there is a gap in research regarding the effectiveness of tele-rehabilitation specifically in the Asian population, particularly in countries like India where osteoarthritis is prevalent, highlighting the need for further study in this context.Methods: RCT recruiting 54 subjects with chronic OA. Participants will be allocated randomly into tele-rehab group and control group. After randomization tele rehabilitation group will undertake rehab through zoom meeting and control group will undertake a standardized treatment for 4 weeks. Main outcomes are WOMAC, NPRS, SF-36 recorded at baseline and 4th week. Other outcome is PGIC.
|