| CTRI Number |
CTRI/2026/01/102312 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Task based Vestibular Rehabilitation] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study How task-based balance and movement activities helps person with Vertigo Improve Balance and occupational performance |
|
Scientific Title of Study
|
Effectiveness of task based vestibular rehabilitation on balance and occupational performance in patient with vertigo |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rishinthan V |
| Designation |
UG Student |
| Affiliation |
Chettinad school of occupational therapy |
| Address |
OT pediatric psychiatry division Ward No 24 Department of Occupational Therapy Chettinad General Hospital Chettinad Health City Rajiv Gandhi Salai OMR Kelambakkam Chennai Tamil Nadu India 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9047238108 |
| Fax |
|
| Email |
ajiirishi21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Angelin Blessy Y |
| Designation |
Assistant professor |
| Affiliation |
Chettinad school of occupational therapy |
| Address |
OT pediatric division, Ward No 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai OMR, Kelambakkam, Chennai, Tamil Nadu, India 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
7358676117 |
| Fax |
|
| Email |
angelinblessy@care.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Angelin Blessy Y |
| Designation |
Assistant professor |
| Affiliation |
Chettinad school of occupational therapy |
| Address |
OT pediatric division, Ward No 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai OMR, Kelambakkam, Chennai, Tamil Nadu, India 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
7358676117 |
| Fax |
|
| Email |
angelinblessy@care.edu.in |
|
|
Source of Monetary or Material Support
|
| Written informed consent will be obtained from parents or legal guardians, along with assent from the participants, prior to enrollment. Ethical approval for the study has been obtained from the Institutional Review Board of Chettinad University Hospital (CHRI, CARE). |
|
|
Primary Sponsor
|
| Name |
Rishinthan V |
| Address |
OT pediatric division, Ward No. 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai OMR, Kelambakkam, Chennai, Tamil Nadu, India 603103 |
| 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 |
| Rishinthan V |
Chettinad general hospital |
OT pediatric division, Ward No. 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai OMR, Kelambakkam, Chennai, Tamil Nadu, India 603103
Kancheepuram
TAMIL NADU |
9047238018
ajiirishi21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee for Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H819||Unspecified disorder of vestibularfunction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Canadian occupational performance measure.
Berg balance scale.
|
The effect of the intervention will be assessed by comparing the results of the pre test collected in the beginning and post test after completing 4 week intervention period. |
| Intervention |
Task based Vestibular rehabilitation |
Before initiating the study, written informed consent will be obtained from all participants after thoroughly explaining the aim, procedures, potential risks, and benefit of the research. Following consent, all participants will undergo a pre-test assessment to establish baseline data. Once the pre-test data has been collected, participants will be randomly allocated into two groups: the Experimental Group and the Control Group. The Experimental Group will receive a structured intervention as per the designed intervention protocol for a period of four weeks. while the Control Group will not receive any intervention by researcher during this time. The experimental group will be given intervention by researcher and care giver will be trained. Subject will perform activities under supervision of caregiver. Follow-up of intervention will be done by researcher using suitable mode of connect eg. Phone call, visits etc.. After the completion of the intervention period, a post-test assessment will be conducted for both groups using the same evaluation tools as the pre-test. The data obtained from the pre-and post-tests will be subjected to statistical analysis to determine the effectiveness of the Intervention |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Individual diagnosed with vertigo based on vertigo symptom scale. Individuals experiencing persistent vertigo symptoms for a minimum of 4 weeks. people age between 30 to 59 - Subjects of both male and female were included |
|
| ExclusionCriteria |
| Details |
Individual with vertigo undergo any other treatment for vertigo Patient with any cardio respiratory disease. Person with any other neurological disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study outcome will be measured using
Canadian occupational performance measure
Berg balance scale |
Occupational performance and Balance will be assessed using the Canadian occupation performance measure and berg balance scale respectively at baseline (pre-intervention), and reassessed after completion of four weeks of task based vestibular rehabilitation occupational therapy intervention (post-intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/02/2026 |
| 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
|
This study is a randomized, parallel group, active controlled trail.
This study is a hospital-based randomized controlled interventional trial designed to evaluate the effectiveness of task based Vestibular rehabilitation on occupational performance and balance among patient with vertigo
A total of 50 participants aged 30 to 59 years, diagnosed with vertigo based on vertigo symptom scale will be recruited from the Department of Occupational Therapy, Chettinad Hospital and other Clinics from Chengalpattu District. Written informed consent will be obtained from patient, prior to enrollment. Ethical approval for the study has been obtained from the Institutional Review Board of Chettinad University Hospital (CHRI, CARE).
Eligible participants will be randomly allocated into two groups: an intervention group (n = 25) and a control group (n = 25). Baseline assessment of occupational performance and balance will be conducted using the Canadian occupational performance scale and berg balance scale respectively The intervention group will receive a task based vestibular rehabilitation delivered for 45 minutes per session, three days per week, over a period of four weeks. The control group will receive no researcher-led intervention during the same period.
At the end of the four-week intervention period, post-intervention assessments will be carried out using the same outcome measures. Pre- and post-intervention scores will be statistically analyzed to determine the effectiveness of the intervention in improving independence among individuals with Vertigo |