| CTRI Number |
CTRI/2026/01/101307 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
04/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [occupational therapy ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Occupational Therapy–Based Interventions for Vertigo- A Prospective Outcome Study |
|
Scientific Title of Study
|
Prospective study to determine the effectiveness of occupational therapy intervention on occupational performance among vertigo pastients |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jane Benita |
| Designation |
PG 2nd year |
| Affiliation |
sri ramachandra institute of higher education and research |
| Address |
Ramachandra Medical college,Trunk rd, Sri Ramachandra Nagar,porur,Chennai 600116
Ramachandra Medical college,Trunk rd, Sri Ramachandra Nagar,porur,Chennai 600116
Chennai
TAMIL NADU
632001
India |
| Phone |
8220046779 |
| Fax |
|
| Email |
janebenita7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Loganathan S |
| Designation |
Assistant Professor |
| Affiliation |
sri ramachandra institute of higher education and research (DU) |
| Address |
Ramachandra Medical college,Trunk rd, Sri Ramachandra Nagar,porur,Chennai 600116
Ramachandra Medical college,Trunk rd, Sri Ramachandra Nagar,porur,Chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841958099 |
| Fax |
|
| Email |
loganathanot@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Loganathan S |
| Designation |
Assistant Professor |
| Affiliation |
Sri ramachandra institute of higher education and research(Du) |
| Address |
Ramachandra Medical college,Trunk rd, Sri Ramachandra Nagar,porur,Chennai 600116
Ramachandra Medical college,Trunk rd, Sri Ramachandra Nagar,porur,Chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841958099 |
| Fax |
|
| Email |
loganathanot@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jane Benita |
| Address |
No.1, Ramachandra Nagar, Sri Ramachandra Nagar, Chennai, Tamil Nadu 600116 |
| 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 |
| Loganathan |
Sri Ramachandra Hospital |
Ramachandra Medical College, Trunk Rd, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU |
9841958099
loganathanot@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, (2) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
occupational therapy intervention |
Acute intervention: Focuses on symptom control, education, safe positioning, gentle visual–vestibular exercises, static balance activities, relaxation, and modified ADL training to reduce dizziness, prevent fear, and ensure safety. |
| Comparator Agent |
occupational therapy intervention |
Chronic intervention: Emphasizes vestibular adaptation, dynamic balance training, functional task practice, dual-task activities, endurance building, confidence enhancement, and community reintegration to restore independence. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed with vertigo by an ENT specialist or neurologist including (Benign Paroxysmal Positional Vertigo, vestibular neuritis, or central vertigo).
2. Adults aged 18 to 65 years will be included.
3. Both acute and chronic cases.
4. Montreal Cognitive Assessment (MoCA) score greater or equal to 26 (to ensure participants can actively engage in therapy tasks).
|
|
| ExclusionCriteria |
| Details |
1. Participants with any other significant medical, neurological, psychiatric and orthopedic conditions will be excluded.
2. Severe physical impairments that would prevent active participation in intervention.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate the effectiveness of occupational therapy interventions in individuals diagnosed with vertigo. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the therapeutic outcomes of occupational therapy between acute & chronic vertigo cases |
12 weeks |
| To reduce vertigo-related symptoms & improve occupational performance in affected individuals. |
12 weeks |
| To evaluate the effectiveness of occupational therapy interventions in individuals diagnosed with vertigo. |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/01/2026 |
| Date of Study Completion (India) |
15/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/06/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
v
After the approval of the
Institutional Ethics Committee.
v
The participants
will be selected using the screening tools.
v
Participants will be
explained about the benefits and risks of the study and will be obtained a
written informed consent in accordance with the guidelines of the Ethics
Committee.
v Participants who meet
with the selection criteria will be divided into two Group:
Group 1 (Acute Vertigo): Onset of vertigo symptoms within the past 4
weeks
Group 2 (Chronic Vertigo): Vertigo symptoms persisting for more than 3
months
v Intervention program
will be provided.
v
The pre and post-test scores
will be evaluated using the outcome measures.
v
The data will be analyzed
and the results will be interpreted.
|