| CTRI Number |
CTRI/2025/12/099536 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [eye gaze training] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Online eye exercises to improve daily performance in elder population |
|
Scientific Title of Study
|
Telerehabilitation of eye gaze training on motor performance in elderly population: 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 |
Lavanya B |
| Designation |
Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research(DU) |
| Address |
Sri Ramachandra Institute of Higher Education and Research(DU), Porur, Chennai,
Department of Physiotherapy
Chennai
TAMIL NADU
600116
India |
| Phone |
9543095969 |
| Fax |
|
| Email |
shakthilavanya13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sai Alekhya B |
| Designation |
Lecturer |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research(DU) |
| Address |
Sri Ramachandra Institute of Higher Education and Research(DU), Porur, Chennai,
Faculty of Physiotherapy, 1st floor
Chennai
TAMIL NADU
600116
India |
| Phone |
8610722512 |
| Fax |
|
| Email |
Saialekhya.b@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Lavanya B |
| Designation |
Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research(DU) |
| Address |
Sri Ramachandra Institute of Higher Education and Research(DU), Porur, Chennai,
Department of Physiotherapy
Chennai
TAMIL NADU
600116
India |
| Phone |
9543095969 |
| Fax |
|
| Email |
shakthilavanya13@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Lavanya B |
| Address |
Sri Ramachandra Institute of Higher Education and Research(DU), Porur, Chennai - 600116, Tamil Nadu, India |
| Type of Sponsor |
Other [Self funding] |
|
|
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 |
| LAVANYA B |
Kaikoduppom charitable trust |
Old Age Home,
Home for elderly population,
ground floor and first floor,
Plot No:- 40, 1st St, Moovendar Nagar, Bharathi Nagar, Veeralakshmi Nagar, Old Perungalathur, Chennai - 600063, Tamil Nadu
Chennai
TAMIL NADU |
9543095969
shakthilavanya13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CSP III Institutional Ethics Committee Sri Ramachandra Institute of Higher Education And Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Balance issues |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Telerehabilitation of Eye gaze training |
Participants will receive online eye gaze training sessions. Exercises will include gaze fixation tasks, saccadic eye movements, visual tracking tasks, visual search tasks and eye hand coordination activities for four sessions over a period of three weeks. The exercise protocol includes warm-up, eye gaze training, cool down. Session duration: thirty minutes |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
This study includes elderly adults aged sixty years and above, of either gender. Individuals able to understand and follow simple instructions in online sessions. Participants with mild to moderate motor deficits, as identified through the Timed Up and Go (TUG) test. Participants able to access to a smartphone, tablet, or computer with a stable internet connection to attend telerehabilitation sessions. Individuals willingness to participate.
|
|
| ExclusionCriteria |
| Details |
Elderly adults with severe visual impairments like uncorrected blindness. Elderly adults with severe cognitive impairments for eg: advanced dementia, that would prevent active participation in training. Elderly adults diagnosed with neurological conditions (such as Parkinson’s disease, stroke with severe disability, or multiple sclerosis). Elderly adults with serious musculoskeletal disorders (such as advanced arthritis or recent fractures) that may affect mobility or interfere with motor performance testing. Any medical instability (such as uncontrolled hypertension, severe cardiovascular disease, or other conditions contraindicating physical activity) that may pose a safety risk during participation. Inability to operate digital devices or difficulty in following virtual instructions.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of eye gaze training on reaction time, movement accuracy and overall task performance time in elderly adults |
At Pre-test and Post-test |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Function mobility time in seconds |
At Pre-test & Post-test |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
29/12/2025 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
A pre and post experimental trail is planned to be conducted at an old age home, Chennai, Tamil Nadu - 600063. An informed consent will be obtained from the study population. This study includes elderly adults of both genders, aged above sixty who are able to follow instructions and participate in online sessions. Individuals with mild to moderate motor deficits identified using TUG test and the individuals who are able to access smartphone, tablet and computer with stable internet. This study excludes elderly adults with severe visual and cognitive impairment, individuals diagnosed with neurological and musculoskeletal conditions and inability to follow virtual instructions. Before beginning the intervention, the individuals reaction time, movement accuracy and task performance time are to be mentioned in person, using Target touch test and TUG test respectively and then eye gaze training is given as intervention through telerehabilitation. The intervention will be delivered for thirty minutes per session, four sessions per week, over a period of three weeks. The intervention includes gaze fixation tasks, saccadic eye movements, visual tracking tasks, visual search tasks and eye hand coordination activities. After the completion of the training period, all the individuals are again tested with the outcome measures mentioned above. The data collected from pre-test and post-test will be entered into SPSS software for statistical analysis. |