| CTRI Number |
CTRI/2025/01/078916 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Rehabilitation with the help of mobile application] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
POST OPERATIVE EVALUATION OF FUNCTIONAL OUTCOME AND ELBOW REHABILITATION USING MOBILE APPLICATION |
|
Scientific Title of Study
|
Mobile application for post operative elbow rehabilitation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arun Manivell Jeganathan |
| Designation |
Post graduate |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Orthopaedics , Room No 201, Division 1, Saveetha
Institute Of Medical And Technical Sciences, Saveetha Medical
College And Hospitals, Saveetha Nagar ,Thandalam,Kancheepuram
Kancheepuram
TAMIL NADU
602105
India
Chennai
TAMIL NADU
602105
India |
| Phone |
7871875065 |
| Fax |
|
| Email |
jam651arunmanivell@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vijayan B |
| Designation |
Professor |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Orthopaedics , Room No 201, Division 1, Saveetha
Institute Of Medical And Technical Sciences, Saveetha Medical
College And Hospitals, Saveetha Nagar ,Thandalam,Kancheepuram
Kancheepuram
TAMIL NADU
602105
India
Chennai
TAMIL NADU
602105
India |
| Phone |
9884587223 |
| Fax |
|
| Email |
docvijayan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Vijayan B |
| Designation |
Professor |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Orthopaedics , Room No 201, Division 1, Saveetha
Institute Of Medical And Technical Sciences, Saveetha Medical
College And Hospitals, Saveetha Nagar ,Thandalam,Kancheepuram
Kancheepuram
TAMIL NADU
602105
India
Chennai
TAMIL NADU
602105
India |
| Phone |
9884587223 |
| Fax |
|
| Email |
docvijayan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College And Hospital,Thandalam
Chennai
TAMIL NADU
602105
India
|
|
|
Primary Sponsor
|
| Name |
Arun Manivell J |
| Address |
Saveetha Medical College And Hospital,Thandalam
Chennai
TAMIL NADU
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 ARUN MANIVELL J |
Saveetha Medical College and Hospital institutional ethics committee |
Department of Orthopedics , third floor, Saveetha medical college and hospital, Poonamallee , Chennai, Kuthambakkam, Tamil Nadu 602105 ,India .
Saveetha medical college and hospital, Poonamallee,Chennai,Kuthambakkam, Tamil Nadu 602105, India .
Chennai
TAMIL NADU
602105
India
Chennai
TAMIL NADU |
7871875065
jam651arunmanivell@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: S599||Unspecified injury of elbow and forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mobile application "ORTHOFLEX ELBOW" |
The intervention involves the use of the "ORTHOFLEX ELBOW" application, a digital health tool designed to support post-surgical rehabilitation in patients with elbow trauma. This application offers a personalized and interactive approach to recovery by providing condition-specific rehabilitation protocols tailored to the type of injury and surgical fixation. The app includes step-by-step instructional videos for exercises aimed at improving mobility, strength, and function, as well as built-in progress tracking features to monitor patient adherence and recovery milestones. It incorporates validated tools such as the Mayo Elbow Performance Score (MEPS) and American Shoulder And Elbow Score (ASES) for functional outcome assessment. Patients in the intervention group will be provided access to the app immediately after surgery, with the rehabilitation plan customized by their treating surgeon. Daily use of the app is encouraged, with notifications and reminders to ensure adherence. Progress will be reviewed remotely by the healthcare provider, reducing the need for frequent in-person follow-ups while maintaining continuous care. This evaluation will be done for a period of 3 months. |
| Comparator Agent |
Standard Post-operative protocol |
The comparator is the standard post-surgical rehabilitation protocol provided without the use of the "ORTHOFLEX ELBOW" application. Patients in the control group will follow traditional rehabilitation methods, which include an initial in-person consultation with a physiotherapist or treating surgeon to learn exercises appropriate for their injury and surgical procedure. These instructions are typically communicated verbally or via printed guides. Patients will perform these exercises independently at home and attend periodic follow-up visits to assess their progress. Functional recovery in this group will be evaluated using validated tools such as Mayo Elbow Performance Score (MEPS) and American Shoulder And Elbow Score (ASES) during these in-person follow-ups. Unlike the intervention group, the standard care does not involve digital progress tracking or remote monitoring, relying instead on patient compliance and periodic evaluations by the healthcare provider.This evaluation will be done for a period of 3 months. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 16 to 60 years.
Patients who have sustained elbow trauma and have nerve & tendon injuries involving the elbow joint, radial head and neck fractures, proximal ulna fractures, distal humerus fractures, ligamentous injuries.
Open and closed fractures of the elbow joint.
|
|
| ExclusionCriteria |
| Details |
Patients who are less than 16 years or more than 60 years.
Patients who are not fit for surgery.
Patients with head injury.
Patients who are not willing for surgery.
Patients with non-union or malunion and have been treated by native splinting.
|
|
|
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 |
| Functional Recovery: Improvement in activities of daily living (ADLs) measured using validated scoring systems such as the Mayo Elbow Performance Score (MEPS) and American Shoulder and Elbow Score (ASES) at 12 weeks post-surgery. Functional recovery includes assessing range of motion, pain levels, stability, and overall performance of the elbow joint. |
12 weeks |
|
|
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 months |
|
|
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)
|
28/01/2025 |
| 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
|
Brief
Presentation on Elbow Rehabilitation Application
Overview
The Elbow
Rehabilitation Application is a comprehensive digital solution designed to
facilitate the recovery process for patients with elbow injuries and surgeries.
It offers personalized rehabilitation programs, enabling remote care with
minimal physical follow-ups. The app includes features for both doctors and
patients, providing a streamlined interface for progress tracking and outcome
evaluation.
Key Features
1. Doctor
and Patient Profiles: Doctors can create customized rehabilitation plans for
their patients based on injury type, while patients can access these plans via
their profiles.
2. Exercise
Videos: Tailored exercise videos for specific types of fractures (distal
humerus, radial head, olecranon) and nerve injuries (ulnar, radial) guide
patients through their rehabilitation.
3. Progress
Tracking: The app tracks patient progress through daily exercise logs and
milestone achievements, sending real-time feedback to doctors.
4.
Functional Outcome Evaluation: Advanced metrics assess recovery without the
need for in-person follow-ups, reducing hospital visits and improving patient
compliance.
5. Remote
Monitoring: Doctors can remotely monitor progress, adjust rehabilitation
protocols, and intervene if needed, ensuring personalized, ongoing care. |