| CTRI Number |
CTRI/2026/02/103638 [Registered on: 11/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
The Effect of Brain Training Games and Acceptance Based Therapy on Recovery After Stroke |
|
Scientific Title of Study
|
Impact of Game based Cognitive Training and Acceptance and Commitment Therapy on Stroke Survivors A Randomised Controlled Trial |
| Trial Acronym |
CogACTive Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyadarshini K |
| Designation |
PhD Scholar |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
No 1 Ramachandra Nagar Porur Chennai 600 116
No 16 Pillaiyar Kovil street Sesarapet Puducherry 605 111
Chennai
TAMIL NADU
600116
India |
| Phone |
6369909542 |
| Fax |
|
| Email |
priyadarshini0200@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijiyalakshmi P |
| Designation |
Professor and Head of the department of Applied Psychology |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
3rd floor Principal OF FBSS office Department of Applied Psychology Faculty of Behavioural and Social Sciences SRIHER (DU) No 1 Ramachandra Nagar Porur Chennai 600 116
Chennai
TAMIL NADU
600 116
India |
| Phone |
9840723539 |
| Fax |
|
| Email |
vijayalakshmi.p@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vijiyalakshmi P |
| Designation |
Professor and Head of the department of Applied Psychology |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
3rd floor Principal OF FBSS office Department of Applied Psychology Faculty of Behavioural and Social Sciences SRIHER (DU) No 1 Ramachandra Nagar Porur Chennai 600 116
Chennai
TAMIL NADU
600 116
India |
| Phone |
9840723539 |
| Fax |
|
| Email |
vijayalakshmi.p@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institite of Higher Education and Research |
| Address |
No 1 Ramachandra Nagar Porur Chennai 600116 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vijayalakshmi P |
Sri Ramachandra Institute of Higher Education and Research |
3rd floor Principal OF FBSS office Department of Applied Psychology Faculty of Behavioural and Social Sciences SRIHER (DU) No 1 Ramachandra Nagar Porur Chennai 600 116
Chennai
TAMIL NADU |
9840723539
vijayalakshmi.p@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SRU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
standard care of treatment as per institutional guidlines |
| Intervention |
Game-based Cognitive Training and Acceptance and Commitment Therapy |
Game-Based Cognitive Training
Participants undergo Game-Based Cognitive Training focusing on attention, memory and Visuospatial 3 to 5 sessions per week for 8 weeks. Cognitive abilities can be improved using CogReviver Smartphone App
Acceptance and Commitment Therapy- Participants undergo ACT-based programme individual sessions of 60 min during a period of 8 weeks focusing on mindfulness, self-compassion, trauma-focused acceptance and stroke-related topics are discussed during the treatment |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed with ischemic stroke in the chronic phase ie greater than or equal to 3 months after the event
Age range 20 t0 60
Absence of disabling sensory impairment ie hearing and visual impairment
Modified Rankin Scale mRS score greater than or equal to 3 which explains 3 Moderate disability 2 Slight disability 1 No significant disability Medically stable participants confirmed by a neurologist or physician
|
|
| ExclusionCriteria |
| Details |
Intake of psychoactive drugs potentially interferes with the training
Presence of neurological disorders other than the first ever ischemic stroke
Absence of the ability to understand the verbal delivery of a simple order
Presence of debilitating behavioural alterations and severe psychiatric symptoms
MoCA scores lesser than or equal to 18
Participants who took part in the pilot study will be excluded |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| For cognitive function, Addenbrooke’s Cognitive Examination-ACE-III and, for the mindfulness characteristics, the Mindfulness Attention Awareness Scale (MAAS) will be measured. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Fatigue—Multidimensional Fatigue Inventory-20
Anxiety—Hamilton Anxiety Rating Scale (HAMA)
Depression—Hamilton Depression Rating Scale (HAMD)
Sleep quality—Pittsburgh Sleep Quality Index (PSQI)
Activities of Daily Living - Barthel Index
Quality of Life—WHOQOL-BREF
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
02/03/2026 |
| 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="5"
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 study proposes a randomized controlled trial to investigate the effects of an 8-week combined intervention on ischemic stroke survivors. The intervention group will receive game-based cognitive training via a smartphone app and weekly Acceptance and Commitment Therapy sessions, while the control group receives standard care. The study aims to recruit 44 participants to assess primary outcomes of cognitive function and mindfulness, along with secondary outcomes like fatigue, mood, sleep, and quality of life, measured before, immediately after, and 12 weeks post-intervention. Data analysis will determine the program’s efficacy, with all procedures conducted under ethical approval and informed consent. |