| CTRI Number |
CTRI/2025/09/094128 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Testing Brain Gym Exercises to Improve Thinking and Sleep During Stroke Recovery |
|
Scientific Title of Study
|
Effect of Brain gym exercise on cognition and sleep quality In Stroke: An experimental study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshita Shete |
| Designation |
Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul Institute of Physiotherapy Parul University Neuro OPD Room no.201 Post Office Limda Taluka Waghodia Vadodara Gujarat
391760
India
Parul Institute of Physiotherapy Parul University Neuro OPD Room no.201 Post Office Limda Taluka Waghodia Vadodara Gujarat
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
8104738885 |
| Fax |
|
| Email |
Sharvarishete20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jigisha Vaniya |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul Institute of Physiotherapy Parul University Neuro OPD Room no.201 Post Office Limda Taluka Waghodia Vadodara Gujarat
391760
India
Parul Institute of Physiotherapy Parul University Neuro OPD Room no.201 Post Office Limda Taluka Waghodia Vadodara Gujarat
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
800070593 |
| Fax |
|
| Email |
jigishavaniya95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jigisha Vaniya |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul Institute of Physiotherapy Parul University Neuro OPD Room no.201 Post Office Limda Taluka Waghodia Vadodara Gujarat
391760
India
Parul Institute of Physiotherapy Parul University Neuro OPD Room no.201 Post Office Limda Taluka Waghodia Vadodara Gujarat
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
800070593 |
| Fax |
|
| Email |
jigishavaniya95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Sevashram Hospital Parul University Neuro OPD Room no.201 Post Office Limda Taluka Waghodia Vadodara Gujarat
391760
India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Harshita Shete |
Parul Sevashram Hospital |
2nd Floor Neurophysiotherapy Department Room no.201 Post Office Limda Taluka Waghodia
Vadodara
GUJARAT |
391760
Sharvarishete20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, (2) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brain Gym Exercise |
Cross Crawl, The Grounder, Balance buttons, Neck rolls, The Owl, Gravity Glider, Lazy 8, Double doodle, Belly Breathing, Positive Points, Thinking X, Energizer, Energy Yawn, The Elephant, |
| Comparator Agent |
Conventional Physiotherapy |
The routine exercise program consisted of
stretching exercise
balance training,
functional exercise
cognitive training and usual care with medicine
Breathing exercises: Pursed lip breathing and diaphragmatic breathing exercises.
The individual should inhale for 4 s and exhale for 8 s, ensuring that the exhalation lasts
twice as long as the inhalation. Pursed lip breathing should be practiced in conjunction
with diaphragmatic breathing exercises for 10 min. A 1-min rest was allowed after every 5
min of exercise.
Relaxation exercises
Jacobson (progressive muscle relaxation technique.)
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with first ever stroke more than 3 months.
Moderate Severity Insomnia (15-24 score on Insomnia severity index )
MMSC score 18-23 (Mild cognitive impairment )
Patients willing to sign consent form |
|
| ExclusionCriteria |
| Details |
Metabolic and respiratory disorders
Presence of significant medical complications or unstable vital signs that precluded participation in the study (orthopedic condition such as severe arthritis), fracture of lower limb, replacement arthroplasty of lower limb.
• Patient with cardiac diseases.
Patient with Movement disorder
Hemiplegia due to Traumatic Brain Injury
Participants with previous history of stroke, any neurological visual or vestibular disorders, any compressive vascular disorders, brain infections, brain tumor, systemic illnesses, psychiatric disorders and with widespread mental deterioration
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Montreal Cognitive Assessment (MoCA) scale
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pittsburgh sleep quality index (PSQI) |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
15/09/2025 |
| 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 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
|
Background:
Stroke often leads to impairments in cognitive functions such as attention, memory, and problem-solving, along with poor sleep quality. These issues can slow down recovery and reduce quality of life. Non-pharmacological interventions like Brain Gym—a series of simple, structured physical and mental exercises—are believed to enhance brain function, improve neural connections, and promote relaxation. Previous research has shown Brain Gym’s potential benefits in children and older adults, but its role in stroke rehabilitation, especially in improving both cognition and sleep, is less explored. Purpose of the Trial:
This study aims to investigate the effect of Brain Gym exercises on cognitive performance and sleep quality in individuals recovering from stroke. By assessing changes before and after a structured Brain Gym intervention, the trial seeks to determine whether this approach can be an effective, low-cost addition to conventional stroke rehabilitation. |