| CTRI Number |
CTRI/2025/10/096648 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [[App-based digital monitoring and risk stratification tool (Stroke360)] ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing app based monitoring with standard care to predict complications and improve recovery in acute stroke patients
|
|
Scientific Title of Study
|
Risk stratification and early complication prediction in acute stroke patients using integrated scoring models |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr AVINASH P V |
| Designation |
Post graduate, General medicine |
| Affiliation |
SAVEETHA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu, India 602105.
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
09962707427 |
| Fax |
|
| Email |
avinashviji96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MARIRAJ I |
| Designation |
Professor |
| Affiliation |
SAVEETHA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu, India 602105.
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
07299376822 |
| Fax |
|
| Email |
justmariraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr AVINASH P V |
| Designation |
Post graduate, General medicine |
| Affiliation |
SAVEETHA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu, India 602105.
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
09962707427 |
| Fax |
|
| Email |
avinashviji96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical college and hospital, Saveetha nagar, Thandalam, CH- 602105, Tamilnadu |
|
|
Primary Sponsor
|
| Name |
SAVEETHA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu, India 602105. |
| Type of Sponsor |
Research institution and hospital |
|
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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 Avinash P V |
Saveetha medical college and hospital |
Room number 1, Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu, India 602105.
Kancheepuram
TAMIL NADU |
09962707427
avinashviji96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| saveetha medical college and hospital institutional ethics commitee |
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 |
| Comparator Agent |
Standard Stroke Care and Follow-Up |
Patients in this group will receive standard institutional management for acute stroke, including clinical monitoring, medication, and rehabilitation counseling without the use of the Stroke360 app. Outcome data including complications and functional status will be assessed during follow-up visits at 14 days and 90 days.
|
| Intervention |
stroke360 App based monitoring |
Patients in this group will be monitored using the Stroke360 mobile application, which integrates validated clinical scoring models (NIHSS, mRS, A2DS2, HAT, SeLECT, SOAR, iScore, SPI-II) for real-time risk stratification and early and late complication prediction in acute stroke.
The app provides a clinician dashboard for risk alerts, a patient interface for medication and rehabilitation tracking, and educational modules for adherence.Follow-up will be done at 14 days and 90 days after admission. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Clinically and radiologically confirmed diagnosis with acute ischaemic stroke.
2)Ability to consent
3)Haemodynamically stable
|
|
| ExclusionCriteria |
| Details |
1)Age above 80 years or age less than 18 years
2)nability to consent
3)Stroke mimics ( e.g., seizures, migraines)
4)Patient with incomplete clinical or imaging records |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
1) Functional outcome at 90 days — measured by Modified Rankin Scale (mRS) score at baseline (on admission), 14 days, and 90 days.
2) Incidence of early and late complications among acute stroke patients, including stroke-associated pneumonia, symptomatic intracerebral hemorrhage (sICH), recurrent stroke, and post-stroke seizures — assessed during hospitalization (up to 14 days) and at 3 months follow-up. |
Baseline (Day 0), Day 14, and Day 90. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in NIHSS and mRS scores from baseline to 90 days, medication and rehabilitation adherence rates (via app data), readmission and mortality within 90 days, and correlation of integrated risk scores (A2DS2, HAT, SeLECT, SOAR, iScore) with actual early and late complications. |
Baseline (Day 0), Day 14, and Day 90.
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/11/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a prospective, comparative, followup study designed to evaluate the effectiveness of an app-based integrated scoring system Stroke360 in predicting early and late complications among patients with acute stroke. The mobile application automatically computes validated risk scores such as NIHSS, mRS, A2DS2, HAT, SeLECT, SOAR, and iScore from structured clinical data to assist in real time risk stratification and complication prediction.Sixty adult patients with confirmed acute stroke will be enrolled and divided into two groups: one receiving app-assisted monitoring Stroke360 group and the other receiving standard care control group. Each patient will be followed up at 14 days and 90 days after admission to assess neurological recovery, functional outcome, and occurrence of complications.The study aims to determine whether continuous, app-based monitoring improves early complication detection, functional recovery, medication adherence, and overall outcome compared to usual stroke care. Findings will help establish an evidence based digital tool for integrated stroke risk management and prognosis prediction.
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