| CTRI Number |
CTRI/2026/03/105911 [Registered on: 11/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [COGNITIVE REHABLITATION ] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Brain exercises on memory and daily activity among neurological patients. |
|
Scientific Title of Study
|
Effectiveness of Cognitive rehabilitation on cognitive level, activities of daily living, social function and Physiological parameters among neurological patients with Mild Cognitive Impairment (MCI) in the Tertiary Institute of Bhopal. |
| Trial Acronym |
NIl |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
kumarasamy A P |
| Designation |
Phd Scholar |
| Affiliation |
saveetha college of nursing, SIMATS, Chennai |
| Address |
Assistant professor, Nursing college, AIIMS Bhopal, Bhopal, MP
PhD scholar, Saveetha college of nursing, SIMATS, Chennai
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
09216188229 |
| Fax |
|
| Email |
apkmsn2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.Thenmozhi .P |
| Designation |
professor |
| Affiliation |
saveetha college of nursing, SIMATS, Chennai |
| Address |
Professor, Saveetha college of nursing, SIMATS, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
8838374627 |
| Fax |
|
| Email |
thenmozi.sethu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
kumarasamy A P |
| Designation |
Phd Scholar |
| Affiliation |
saveetha college of nursing, SIMATS, Chennai |
| Address |
Assistant professor, Nursing college, AIIMS Bhopal, Bhopal, MP
PhD scholar, Saveetha college of nursing, SIMATS, Chennai
MADHYA PRADESH
462020
India |
| Phone |
09216188229 |
| Fax |
|
| Email |
apkmsn2@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS BHOPAL, MADHYAPRADESH ,INDIA-462020 |
|
|
Primary Sponsor
|
| Name |
KUMARASAMY AP |
| Address |
ASSISTANT PROFESSOR, NURSING COLLEGE, AIIMS BHOPAL, india-462020 |
| 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 |
| DrKUMARASAMY AP |
All India Institute of Medical Sciences, Bhopal |
ROOM NO 3, IST FLOOR, NURSING COLLEGE.
MADHYA PRADESH
Bhopal
MADHYA PRADESH |
9216188229
apkmsn2@gamail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHECAIIMSBHOPAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitive rehabilitation |
The intervention program consists of structured cognitive exercises and mindful meditation practices conducted over six weeks. Cognitive training includes visuospatial/executive, naming, memory, attention, language, abstraction, and orientation exercises. Participants will perform three cognitive exercises per day, each lasting 10 minutes, three days per week, totaling six sessions over two weeks. This is followed by mindful meditation practices such as breath awareness, body scan, mountain meditation, observing thoughts, loving-kindness meditation, and integrating mindfulness into daily life. Similarly, participants will engage in three meditation sessions per day, each lasting 10 minutes, three days per week, totaling six sessions over two weeks. The program will be continued for up to six weeks to reinforce and sustain cognitive and functional improvements.
|
| Comparator Agent |
Routine practice |
participants will receive standard neurological care as routinely provided in the hospital. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
The patients who will be-
1.above age 18
2.Both male and female
3.MCI scores within the range of 19-26 on the Montreal Cognitive Assessment (MoCA).
4.diagnosed with neurological condition (e.g., stroke, traumatic brain injury, glioma, neurodegenerative disorders) that may contribute to cognitive impairment.
5.willing to participate in the study
6.listen and understand Hindi and English
|
|
| ExclusionCriteria |
| Details |
The patients who will be-
1.with major psychiatric disorders (e.g., severe depression, schizophrenia) that could affect cognitive function or compliance.
2.having severe physical limitations and visual impairment that would prevent participation in cognitive rehabilitation exercises or mindful meditation.
3.with a history of substance abuse that could impact cognitive function or interfere with the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effectiveness of Cognitive Rehabilitation on cognitive level, activities of daily living (ADL) among neurological patients with Mild Cognitive Impairment (MCI) in experimental group. |
2nd and 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the effectiveness of Cognitive Rehabilitation on social function, and physiological parameters among neurological patients with Mild Cognitive Impairment (MCI) in experimental group. |
2nd and 6th week |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
23/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/03/2026 |
| 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
|
Mild Cognitive Impairment
(MCI) in neurological patients is a growing public health concern, particularly
in developing countries like India, where aging populations and increasing
incidences of stroke, traumatic brain injury, and neurodegenerative diseases
contribute to the cognitive burden. non-pharmacological interventions such as
cognitive rehabilitation have shown promising outcomes in improving cognitive
and functional status. Cognitive Exercises
combined with Mindfulness Meditation presents a holistic and evidence-based
approach that addresses not only the cognitive but also the emotional and
physiological challenges faced by individuals with MCI.
The proposed study, therefore, is justified in its aim
to evaluate the effectiveness of cognitive rehabilitation on cognitive function,
activities of living, social functioning, and selected physiological parameters
among neurological patients diagnosed with MCI |