| CTRI Number |
CTRI/2024/12/078391 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| 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
|
Mobile App to Help Treating the Shoulder Problems |
|
Scientific Title of Study
|
Mobile application for Shoulder 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 |
Naveen Kumar |
| 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 |
9600805455 |
| Fax |
|
| Email |
naveensmart97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Raja Purushothaman |
| Designation |
Professor |
| 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 |
9840778281 |
| Fax |
|
| Email |
drbone04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Raja Purushothaman |
| Designation |
Professor |
| 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 |
9840778281 |
| Fax |
|
| Email |
drbone04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha medical college and hospital, Poonamallee,Chennai,Kuthambakkam, Tamilnadu
602105 ,India |
|
|
Primary Sponsor
|
| Name |
Naveen kumar |
| 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 M Naveen Kumar |
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
Tamilnadu.
Chennai
TAMIL NADU |
9600805455
naveensmart97@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: M249||Joint derangement, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mobile Application
"SHOULDER ASSIST" |
Patients undergoing shoulder rehabilitation will use the
mobile application "SHOULDER ASSIST" as part of their shoulder 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.The app aims to enhance patient engagement, adherence to rehabilitation exercises, and overall recovery. |
| Comparator Agent |
Standard shoulder rehabilitation |
Patients undergoing shoulder rehabilitation will follow
the standard rehabilitation protocol prescribed by the healthcare providers. This typically includes physiotherapy, home exercises,
and follow-up visits but excludes the use of any mobile
application or technology-based support for recovery. The comparator group serves as the control to evaluate the
outcomes of the standard care
process without the integration
of the "SHOULDER ASSIST" app.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who needs shoulder rehabilitation
Individuals who have access to a smartphone or tablet device with internet connectivity.
Participants willing and able to engage in post-operative rehabilitation exercises and activities.
Patients with sufficient understanding and proficiency in the language(s) supported by the mobile application.
Patients who have completed the immediate post-operative recovery phase and have been cleared by their healthcare provider to begin rehabilitation. |
|
| ExclusionCriteria |
| Details |
Individuals with cognitive impairments or mental health conditions that may affect their ability to use the mobile application effectively.
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 , to avoid confounding variables. |
|
|
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 shoulder function, range of motion,strength, and mobility, as measured by validated
clinical scales over the study period.
|
3 weeks after the start of rehabilitation |
|
|
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)
|
29/12/2024 |
| 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="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 shoulder rehabilitation aims to enhance the recovery process and outcomes for patients . Through a user-friendly platform, the app guides patients through their rehabilitation exercises, tracks their progress, and educates them about 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 |