| CTRI Number |
CTRI/2024/12/077705 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Rehabilitation with help of mobile application] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Smart App for Faster Healing After Knee Replacement. |
|
Scientific Title of Study
|
Mobile application for Post operative rehabilitation after Total Knee Replacement surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raja Balaji |
| Designation |
Post graduate |
| Affiliation |
Saveetha medical college and hospital. |
| Address |
Department of Orthopedics , third floor, Saveetha medical college and hospital, Poonamallee , Chennai, Kuthambakkam, Tamil Nadu 602105 ,India .
Chennai
TAMIL NADU
602105
India |
| Phone |
6379200310 |
| Fax |
|
| Email |
rajabalaji1278@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Navin Balasubramanian |
| Designation |
Professor |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of Orthopedics , third floor, Saveetha medical college and hospital, Poonamallee , Kuthambakkam, Tamil Nadu 602105 ,India .
Chennai
TAMIL NADU
602105
India |
| Phone |
9486106167 |
| Fax |
|
| Email |
drnavin_ortho@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Navin Balasubramanian |
| Designation |
Professor |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of Orthopedics , third floor, Saveetha medical college and hospital, Poonamallee , Kuthambakkam, Tamil Nadu 602105 ,India .
.
Chennai
TAMIL NADU
602105
India |
| Phone |
9486106167 |
| Fax |
|
| Email |
drnavin_ortho@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Saveetha medical college and hospital, Poonamallee,Chennai,Kuthambakkam, Tamilnadu 602105 ,India . |
|
|
Primary Sponsor
|
| Name |
Raja balaji |
| Address |
Saveetha medical college and hospital, Poonamallee,Chennai,Kuthambakkam, Tamilnadu 602105 ,India . |
| 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 S V RAJABALAJI |
Saveetha medical college and hospital Institutional Ethics Committe |
Department of Orthopedics , third floor, Saveetha medical college and hospital, Poonamallee , Chennai, Kuthambakkam, Tamil Nadu 602105 ,India .
Chennai
TAMIL NADU |
6379200310
rajabalaji1278@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college and hospital institutional ethics 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 |
| Comparator Agent |
Conventional Rehabilitation Without Mobile Application Support. |
Traditional rehabilitation without the use of a mobile application, relying on standard physical therapy protocols or patient-guided exercises. |
| Intervention |
Mobile Application "BENDEASE" |
Patients undergoing Total Knee Replacement (TKR) will use the mobile application "BENDEASE" as part of their post-operative rehabilitation protocol. The app provides structured guidance for recovery, including tailored exercise programs, reminders, progress tracking, and educational content to improve functional outcomes and activities of daily living after surgery. The app aims to enhance patient engagement, adherence to rehabilitation exercises, and overall recovery. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
All patients who underwent primary total knee arthroplasty for primary end-stage osteoarthritis were included |
|
| ExclusionCriteria |
| Details |
Patients outside the age range of 45–95 years were excluded. Patients who suffered from neurological diseases or secondary osteoarthritis, as well as those who underwent revision surgery were not included. Patients who underwent other joint replacement surgeries were also excluded
Patients with contraindications or complications that require specialized rehabilitation interventions beyond the scope of the mobile application.
Participants with severe mobility limitations or comorbidities that may prevent them from safely performing rehabilitation exercises.
Patients who are unable or unwilling to provide informed consent for participation in the study.
Individuals currently participating in other rehabilitation programs or clinical trials targeting post-TKR recovery, to avoid confounding variable |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Enhanced functional recovery, including improvements in knee function, range of motion, strength, and mobility, as measured by validated clinical scales over the study period. |
At 12 weeks post-surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improved rehabilitation adherence rates assessed through engagement metrics in the mobile application.
Increased patient satisfaction evaluated via standardized satisfaction surveys.
Reduction in healthcare utilization, including fewer in-person visits and lower medical costs. |
3 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/12/2024 |
| 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
|
The mobile application for post-operative rehabilitation
after total knee replacement surgery aims to enhance the recovery process and
outcomes for patients undergoing this procedure. Through a user-friendly
platform, the app guides patients through their rehabilitation exercises,
tracks their progress, and educates them about the post-operative recovery
journey. Furthermore, it fosters communication between patients and healthcare
providers, facilitating timely support and guidance. Overall, the app seeks to
improve patient engagement and adherence to rehabilitation protocols,
ultimately leading to better recovery outcomes and overall satisfaction with
the treatment process |