| CTRI Number |
CTRI/2025/11/098053 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to understand the effectiveness of gaze stability exercises on spatial cognitive performance in healthy young adults. |
|
Scientific Title of Study
|
Effectiveness of gaze stability exercises on spatial cognition in healthy young adults: A randomised controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Barnana Roy |
| Designation |
PhD Scholar |
| Affiliation |
Garden City University |
| Address |
Room no 44, Department of Physiotherapy , School of Health sciences, Garden City University,16th KM, Old Madras Road, Bangalore – 560049, Karnataka, India
Bangalore
KARNATAKA
560049
India |
| Phone |
9038110948 |
| Fax |
|
| Email |
roybarnana1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Senthil Kumar Natrajan |
| Designation |
Assistant Professior ,Guide |
| Affiliation |
Garden City University |
| Address |
Room no 44, Department of Physiotherapy , School of Health sciences, Garden City University,16th KM, Old Madras Road, Bangalore – 560049, Karnataka, India
Bangalore
KARNATAKA
560049
India |
| Phone |
7010340650 |
| Fax |
|
| Email |
Senthilkumar.n@gcu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Senthil Kumar Natrajan |
| Designation |
Assistant Professior ,Guide |
| Affiliation |
Garden City University |
| Address |
Room no 44, Department of Physiotherapy , School of Health sciences, Garden City University,16th KM, Old Madras Road, Bangalore – 560049, Karnataka, India
Bangalore
KARNATAKA
560049
India |
| Phone |
7010340650 |
| Fax |
|
| Email |
Senthilkumar.n@gcu.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Barnana Roy |
| Address |
16th KM, Old Madras Road, Bangalore – 560049, Karnataka, India |
| Type of Sponsor |
Other [Private University] |
|
|
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 Barnana Roy |
Garden City University |
Room no 44, Department of Physiotherapy , School of Health sciences, Garden City University,16th KM, Old Madras Road, Bangalore – 560049, Karnataka, India
Bangalore
KARNATAKA |
9038110948
roybarnana1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GCU-Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Spatial Cognition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gaze Stability Exercises |
Gaze Stability Exercises , 4 times a week for 6 weeks, 40 minutes session(excluding rest period) |
| Comparator Agent |
Placebo eye exercise |
Placebo eye exercise, 4 days a week for 6 weeks, 40 minutes session (excluding rest period) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
1)No prior exposure or experience to gaze stability exercises.2)Normal or corrected-to-normal vision.3) Normal hearing abilities
|
|
| ExclusionCriteria |
| Details |
Any cardiovascular, neurological and musculoskeletal disorders and psychiatric illness. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mental Rotation , Spatial orientation, Visuospatial ability , Visuospatial Working memory |
At baseline and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
05/12/2025 |
| 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="3"
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
|
This study is a randomised, single blind , parallel group placebo controlled trial to understand the effectiveness of gaze stability exercises on spatial cognition in healthy young adults for 6 weeks in minimum 60 healthy participants from department of physiotherapy , Garden City University , Bengaluru, India . Gaze stability exercises and placebo eye exercises will be given to experimental and control group respectively. The primary outcome measures - mental rotation test ( Vandenberg and kuse MRT score ), spatial orientation ( Perspective taking and spatial orientation test score) , visuospatial ability ( Design Organization test ) , visuospatial working memory ( Corsi and backward corsi block tapping test by psytoolkit ) will be taken at baseline and post the trial at 6 weeks . |