| CTRI Number |
CTRI/2024/08/072991 [Registered on: 27/08/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effects of brain power enhancing exercise versus brain gym exercise on attention and memory in adults age between 20 to 30 years old. |
|
Scientific Title of Study
|
Effectiveness of Brain gym exercise versus Neurobic exercise on attention and memory in early adulthood. A comparative 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 |
Dhruvi Chhaya |
| Designation |
MPT student |
| Affiliation |
Parul Institute of Physiothearpy |
| Address |
room no.309 3rd floor , parul institue of physiotherapy, Parul university, Limbda, Waghodia, vadodara, gujarat
Vadodara GUJARAT 391760 India |
| Phone |
7575029923 |
| Fax |
|
| Email |
dhruvichhaya1@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Joyal Tejpal |
| Designation |
Assistant professor |
| Affiliation |
Parul Institute of Physiothearpy |
| Address |
room no.309 3rd floor , parul institue of physiotherapy, Parul university, Limbda, Waghodia, vadodara, gujarat
Vadodara GUJARAT 391760 India |
| Phone |
9909981454 |
| Fax |
|
| Email |
joyal.tejpal25384@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Joyal Tejpal |
| Designation |
Assistant professor |
| Affiliation |
Parul Institute of Physiothearpy |
| Address |
room no.309 3rd floor , parul institue of physiotherapy, Parul university, Limbda, Waghodia, vadodara, gujarat
Vadodara GUJARAT 391760 India |
| Phone |
9909981454 |
| Fax |
|
| Email |
joyal.tejpal25384@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Room no.309 3rd floor, Parul institute of physiotherapy, Parul university, Limda, Waghodia, Vadodara
Gujarat
391760
India |
|
|
Primary Sponsor
|
| Name |
Dhruvi chhaya |
| Address |
room no.309 3rd floor, Parul institute of physiotherapy, Parul university, Limda, Waghodia, Vadodara
Gujarat
391760
India |
| 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 |
| Dr Dhruvi Chhaya |
Parul Institute of Ayurveda |
Room Number- 202
Division- 2nd floor
Department- Ayurveda OPD
Vadodara GUJARAT |
7575029923
dhruvichhaya1@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 |
| Healthy Human Volunteers |
Attention and memory |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brain Gym exercise |
Frequency - 4 days per week
Duration- 25-30 minutes
Sessions- 16 sessions for 4 weeks
Cross Crawl
Trace X
Step Touch
Neck Circle
Gravity Gliders
Lazy Eight
Brain Button
Thinking Cap |
| Comparator Agent |
Neurobic exercises |
Frequency - 4 days per week
Duration- 25-30 minutes
Sessions- 16 sessions for 4 weeks
Backward Walking
Dailing Numbers with non-dominant hand
Buttoning with eyes close
Getting dressed with eyes close
Jogging with listening music
Wearing watch upside down
Opening doorknob with eyes closed
Brushing and combing with non-dominant hand |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group between 20 to 30 years
2. Both male and female
3. Willingness to participate in the study throughout the program
4. Normal physical senses
5. Participants who did not participate in any other research from last 1 year
6. Digit span test number error below 7
|
|
| ExclusionCriteria |
| Details |
1. Any neurological condition
2. Any psychiatric disorder
3. Visual or hearing impairment
4. Any physical or mental disability restricting the implementation of exercise |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Digit Span Test |
4 days per week
For 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Memory Failures of Everyday Questionnaire |
4 days per week
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="84" Sample Size from India="84"
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)
|
05/09/2024 |
| 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
|
Due to digitalisation, there may be affection in attention span and memory in young adults. Since the phase of early adulthood is considered as the phase of transition, higher level of stress is found in these population as compared to
childhood or older adults resulting in affection in attention span and memory. Due to ageing, there will be gradual cognitive decline. Hence early-stage prevention of cognitive decline is important. Neurobic exercise is a unique brain exercise which uses all the six senses in unexpected way to strengthen nerve cell stimulation. Brain gym exercise stimulates brain hemisphere by neural remodelling to facilitate whole brain learning. There is lack of awareness and clinical implementation in individuals regarding brain gym and Neurobic exercises. No similar study is done regarding the comparison of these interventions in early adulthood. This study will help to increase awareness and can be implemented clinically on young individuals and to find the comparative effects of these
interventions on attention and memory in young individuals. |