| CTRI Number |
CTRI/2025/03/082040 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Mobile application ] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Mobile application for Rehabilitation of Patients with Stroke
|
|
Scientific Title of Study
|
Novel app for Rehabilitation of Patients with Cerebrovascular Accidents and Comparison of the Incidence of Complications in Patients using the application and Patients on Conventional Follow up
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijay yaswanth reddy bade |
| Designation |
Post Graduate, general medicine |
| Affiliation |
Saveetha Medical College Hospital |
| Address |
Room no:01, Department of General Medicine,Saveetha Medical
College and Hospital ,Saveetha Nagar, Thandalam, Chennai , TAMIL
NADU
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8686862552 |
| Fax |
|
| Email |
iamvjbade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GUNASEKARAN |
| Designation |
Professor, General Medicine |
| Affiliation |
Saveetha Medical College Hospital |
| Address |
Room no:01, Department of General Medicine,Saveetha Medical
College and Hospital ,Saveetha Nagar, Thandalam, Chennai , TAMIL
NADU
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9884398420 |
| Fax |
|
| Email |
drguna59@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GUNASEKARAN |
| Designation |
Professor, General Medicine |
| Affiliation |
Saveetha Medical College Hospital |
| Address |
Room no:01, Department of General Medicine,Saveetha Medical
College and Hospital ,Saveetha Nagar, Thandalam, Chennai , TAMIL
NADU
TAMIL NADU
602105
India |
| Phone |
9884398420 |
| Fax |
|
| Email |
drguna59@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai- 602105 |
|
|
Primary Sponsor
|
| Name |
Saveetha Medical College and Hospital |
| Address |
Saveetha Nagar, Thandalam, Chennai, Tamil Nadu 602105 |
| Type of Sponsor |
Private medical college |
|
|
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 Vijay yaswanth reddy bade |
Saveetha medical college and hospital |
Room number
-01,Department of
General Medicine ,Saveetha nagar,Thandalam kancheepuram
district,chennai-602105
Kancheepuram
TAMIL NADU |
8686862552
iamvjbade@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: G968||Other specified disorders of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Application for rehabilitation of patients with cerebrovascular accidents |
Application based rehabilitation and care of patients with cerebrovascular accidents for 3 month duration |
| Comparator Agent |
Conventional rehabilitation for Cerebrovascular Accidents |
Conventional rehabilitation for Cerebrovascular patients with Drugs, Physiotherapy and other Supportive management for 3 month duration |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing rehabilitation at the specified healthcare facility.
2.Patients with the ability to provide informed consent or with a legally authorized representative available to provide consent on their behalf.
|
|
| ExclusionCriteria |
| Details |
1.Age: Participants under the age of 45 years.
2.Patients with pre-existing conditions or comorbidities that significantly impact rehabilitation outcomes or ability to participate in the study.
3.Patients with a history of substance abuse or psychiatric disorders that may interfere with study participation or compliance with the intervention.
4.Patients with a history of previous strokes or neurological conditions unrelated to the current cerebrovascular accident.
5.Patients with unstable medical conditions or recent surgeries that may affect their ability to participate in the study or adhere to the intervention protocols |
|
|
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 |
Improvement in Physical Function (Physiotherapy Outcomes):
Measure: Change in physical function as assessed by standardized scales like the Modified Rankin Scale (mRS), Barthel Index . |
At baseline and three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reduction in Complications,
2. Quality of Life (QoL) scale
3. Incidence of Additional Medical Complications and secondary stroke
|
At baseline and three months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/03/2025 |
| 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="0"
Months="3"
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 proposed project focuses on the development and evaluation of a novel mobile application for the rehabilitation of patients who have experienced cerebrovascular accidents (CVAs), commonly known as strokes. The study aims to compare the effectiveness of this application with conventional follow-up methods in improving patient outcomes and reducing the incidence of complications.
Cerebrovascular accidents are a significant cause of disability and mortality worldwide, often resulting in impairments in motor function, cognition, and activities of daily living. Traditional rehabilitation approaches involve physical therapy, occupational therapy, and speech therapy, tailored to individual patient needs. However, these methods may have limitations in terms of accessibility, adherence, and monitoring of progress.
With advancements in technology, mobile applications offer a promising platform for delivering personalized rehabilitation interventions. The novel application developed for this study provides interactive exercises, cognitive training, and real-time progress tracking, aiming to enhance the rehabilitation process for CVA patients.
The research involves a randomized controlled trial, where patients are divided into two groups: one utilizing the rehabilitation application alongside standard care, and the other receiving conventional follow-up treatment. Key outcomes measured include functional improvement, quality of life, and the occurrence of complications such as secondary strokes, infections, and functional decline.
Preliminary findings suggest potential benefits of the rehabilitation application in reducing complication incidence and improving rehabilitation outcomes. However, further analysis with a larger sample size and longer follow-up duration is needed to validate these results.
Overall, this study contributes to the growing body of knowledge in stroke rehabilitation and healthcare technology, offering insights into the role of mobile applications in optimizing outcomes and improving the quality of care for CVA patients.
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