| CTRI Number |
CTRI/2025/01/079542 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| 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
|
Postoperative Rehabilitation Using a Mobile-Based App Versus Conventional Follow-Up in ACL Reconstruction Patients: A Comparative Study. |
|
Scientific Title of Study
|
Evaluation of effectiveness of mobile based application versus conventional follow up training for the post operative rehabilitation in ACL reconstruction 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 |
Ramprasath Rajavel |
| Designation |
Postgraduate |
| Affiliation |
SAVEETHA MEDICAL COLLEGE AND HOSPITALS |
| Address |
SAVEETHA Â INSTITUTE OF MEDICAL AND TECHNICAL SCIENCES, SAVEETHA MEDICAL COLLEGE AND HOSPITALS SECOND FLOOR, ORTHOPAEDICS DEPARTMENT, SAVEETHA NAGAR , THANDALAM, CHENNAI, TAMIL NADU, 602105
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9655267799 |
| Fax |
|
| Email |
ramprasathcool99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramprasath Rajavel |
| Designation |
Postgraduate |
| Affiliation |
SAVEETHA MEDICAL COLLEGE AND HOSPITALS |
| Address |
SAVEETHA INSTITUTE OF MEDICAL AND TECHNICAL SCIENCES, SAVEETHA MEDICAL COLLEGE AND HOSPITALS SECOND FLOOR, ORTHOPAEDICS DEPARTMENT, SAVEETHA NAGAR , THANDALAM, CHENNAI, TAMIL NADU, 602105
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9655267799 |
| Fax |
|
| Email |
ramprasathcool99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramprasath Rajavel |
| Designation |
Postgraduate |
| Affiliation |
SAVEETHA MEDICAL COLLEGE AND HOSPITALS |
| Address |
SAVEETHA Â INSTITUTE OF MEDICAL AND TECHNICAL SCIENCES, SAVEETHA MEDICAL COLLEGE AND HOSPITALS SECOND FLOOR, ORTHOPAEDICS DEPARTMENT, SAVEETHA NAGAR , THANDALAM, CHENNAI, TAMIL NADU, 602105
TAMIL NADU
602105
India |
| Phone |
9655267799 |
| Fax |
|
| Email |
ramprasathcool99@gmail.com |
|
|
Source of Monetary or Material Support
|
| SAVEETHA Â INSTITUTE OF MEDICAL AND TECHNICAL SCIENCES, SAVEETHA MEDICAL COLLEGE AND HOSPITALS SECOND FLOOR, ORTHOPAEDICS DEPARTMENT, SAVEETHA NAGAR , THANDALAM, CHENNAI, TAMIL NADU, 602105 |
|
|
Primary Sponsor
|
| Name |
Dr Ramprasath Rajavel |
| Address |
SAVEETHA Â INSTITUTE OF MEDICAL AND TECHNICAL SCIENCES, SAVEETHA MEDICAL COLLEGE AND HOSPITALS SECOND FLOOR, ORTHOPAEDICS DEPARTMENT, SAVEETHA NAGAR , THANDALAM, CHENNAI, TAMIL NADU, 602105 |
| 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 |
| RAMPRASATH RAJAVEL |
SAVEETHA MEDICAL COLLEGE AND HOSPITAL ETHICS COMMITTE |
SAVEETHA Â INSTITUTE OF MEDICAL AND TECHNICAL SCIENCES, SAVEETHA MEDICAL COLLEGE AND HOSPITALS SECOND FLOOR, ORTHOPAEDICS DEPARTMENT, SAVEETHA NAGAR , THANDALAM, CHENNAI, TAMIL NADU, 602105
Kancheepuram
TAMIL NADU |
9655267799
ramprasathcool99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college and hospital ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
mobile application for rehabilitation following post ACL reconstruction surgery |
The app offers personalized exercise programs, progress tracking, and outcome monitoring tools to support recovery. It aims to optimize functional outcomes, improve adherence to rehabilitation protocols, and empower patients with convenient, evidence-based tools for effective knee recovery. |
| Comparator Agent |
Standard in-person follow-up sessions |
This include physical therapy exercises and manual techniques typically prescribed post-ACL surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18-65 years who have recently undergone ACL reconstruction surgery (within 1-3 weeks post-surgery), possess access to a smartphone or tablet, and are capable of using mobile applications are eligible for the study. They must be willing to provide informed consent and be proficient in the language of the study materials |
|
| ExclusionCriteria |
| Details |
Participants will be excluded if they are under 18 or over 60 years old, have not undergone ACL reconstruction surgery, or have other significant knee pathologies (e.g., severe osteoarthritis). Exclusion also applies to individuals with severe medical conditions (e.g., uncontrolled diabetes, cardiovascular diseases), mental health impairments, pregnancy, post-surgical complications, inability to use the app, non-adherence risk, or enrollment in other studies. |
|
|
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 |
Range of Motion (ROM) of the knee.
Pain intensity using a Visual Analog Scale (VAS).
Functional scores (e.g., Lysholm Knee Scoring Scale or International Knee Documentation Committee [IKDC] score). |
Baseline (prior to intervention initiation, 1-3 weeks post-surgery).
4 weeks after starting rehabilitation.
8 weeks after starting rehabilitation.
16 weeks after starting rehabilitation (end of intervention).
strength, and mobility, as measured by validated clinical scales over the study period |
|
|
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)
|
10/02/2025 |
| 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="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 ACL reconstruction 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 |