| CTRI Number |
CTRI/2026/01/101587 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study on Sensory Integration Therapy for Improving Balance in Adults with Vestibular Hypofunction |
|
Scientific Title of Study
|
Effect of Sensory Integration in Adults Having Vestibular Hypofunction |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parul Sharma |
| Designation |
Post graduate student |
| Affiliation |
Shree Guru Gobind Singh Tricentenary University |
| Address |
SGT University Faculty of Physiotherapy, Block B, Gurgaon, Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
8529234083 |
| Fax |
|
| Email |
ps6069008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinika Chaudhary |
| Designation |
Post graduate student |
| Affiliation |
Shree Guru Gobind Singh Tricentenary University |
| Address |
SGT University Faculty of Physiotherapy, Block B, Gurgaon, Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
8529234083 |
| Fax |
|
| Email |
ps6069008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Parul Sharma |
| Designation |
Post graduate student |
| Affiliation |
Shree Guru Gobind Singh Tricentenary University |
| Address |
SGT University Faculty of Physiotherapy, Block B, Gurgaon, Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
8529234083 |
| Fax |
|
| Email |
ps6069008@gmail.com |
|
|
Source of Monetary or Material Support
|
| SGT University Faculty of Physiotherapy Gurgaon, Haryana PIN CODE: 122505 |
|
|
Primary Sponsor
|
| Name |
Parul Sharma |
| Address |
P-2, 2nd Floor, opp. Gate no.4, Near SBI ATM, Charbhuja, Rawatbhata, Rajasthan PIN CODE: 323307, 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 Vinika Chaudhary |
SGT University |
SGT University Faculty of Physiotherapy Block B, Gurgaon, Haryana 122505
Gurgaon
HARYANA |
9650922399
vinika_fphy@sgtuniversity.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Faculty of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Vestibular Rehabilitation Therapy |
The comparator intervention will be administered for 4 weeks, with sessions conducted 5 times per week |
| Intervention |
Sensory Integration Therapy |
The intervention will be administered for 4 weeks, with sessions conducted 5 times per week. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 30–45 years, both males and females.
Diagnosed with vestibular hypofunction based on clinical assessment.
Positive findings on Head Thrust Test and/or Rotatory Chair Test.
Ability to stand and walk independently without assistive devices.
Ability to follow and understand instructions given by the therapist. |
|
| ExclusionCriteria |
| Details |
History of neurological disorders such as stroke, multiple sclerosis, Parkinson’s disease, peripheral neuropathy, or traumatic brain injury.
Any severe musculoskeletal or physical disability affecting balance or mobility.
Severe visual or auditory impairments not corrected by aids.
Any medical condition that may interfere with vestibular rehabilitation or sensory integration training. |
|
|
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 |
| Dynamic Visual Acuity (DVA) Test, Head Thrust Test (HTT), Dynamic Gait Index (DGI), Dizziness Handicap Inventory (DHI), Activity-Specific Balance Confidence (ABC) Scale. |
Dynamic Visual Acuity (DVA) Test, Head Thrust Test (HTT), Dynamic Gait Index (DGI), Dizziness Handicap Inventory (DHI), Activity-Specific Balance Confidence (ABC) Scale for 4Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life, functional independence, and balance confidence in adults with vestibular hypofunction. |
Baseline (pre-intervention)
At the end of 4 weeks (post-intervention) |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
30/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
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
|
Vestibular hypofunction often results in dizziness, balance impairment, and limitations in daily activities, leading to a reduced quality of life in adults. While conventional vestibular rehabilitation is commonly used, evidence regarding the role of sensory integration–based therapy in adults with vestibular hypofunction remains limited. This study aims to evaluate the effectiveness of sensory integration therapy in improving vestibular function, balance, and functional performance. The findings may support the inclusion of sensory integration therapy as an adjunct to standard rehabilitation, helping clinicians enhance treatment outcomes and improve functional independence in affected individuals. |