FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/05/087969 [Registered on: 30/05/2025] Trial Registered Prospectively
Last Modified On: 31/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Occupational Therapy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to identify balance activities effect on reducing fall incidents in people with balance issues. 
Scientific Title of Study   Effectiveness of adapted vestibular activities on fall risk among clients with vestibulopathy. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nivedita 
Designation  PG Scholar 
Affiliation  Chettinad School of Occupational Therapy, CHRI, CARE 
Address  A Block, Department of Occupational Therapy,School of Occupational Therapy,Chettinad Health city,OMR,kelambakkam

Kancheepuram
TAMIL NADU
603103
India 
Phone  6381104283  
Fax    
Email  niveditasingh18392@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pankaj Kumar 
Designation  Professor and Dean 
Affiliation  Chettinad School of Occupational Therapy, CHRI, CARE 
Address  Dean office, Ward no-24,A Block, Department of Occupational Therapy,School of Occupational Therapy,Chettinad Health city,OMR,kelambakkam

Kancheepuram
TAMIL NADU
603103
India 
Phone  9910410156  
Fax    
Email  dean.csot@care.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Pankaj Kumar 
Designation  Professor and Dean 
Affiliation  Chettinad School of Occupational Therapy, CHRI, CARE 
Address  Dean office, Ward no-24,A Block, Department of Occupational Therapy,School of Occupational Therapy,Chettinad Health city,OMR,kelambakkam

Kancheepuram
TAMIL NADU
603103
India 
Phone  9910410156  
Fax    
Email  dean.csot@care.edu.in  
 
Source of Monetary or Material Support  
Room No.24, A block, Chettinad School of Occupational Therapy, Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education, Rajiv Gandhi Salai, OMR, Kelambakkam, Chennai, Tamilnadu,India, 603103  
 
Primary Sponsor  
Name  Nivedita 
Address  ROOM NO-16,Pink Premium Ladies Hostel,SRS Nagar road,Kelambakkam,603103 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrPankaj Kumar  Chettinad General Hospital  Room No.24, OT-Neurology division, Department of Occupational Therapy, Chettinad Healthcity, Rajiv Gandhi Salai, OMR, Kelambakkam, Chennai
Kancheepuram
TAMIL NADU 
9910410156

dean.csot@care.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee (CARE IHEC-I)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H819||Unspecified disorder of vestibularfunction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Adapted Vestibular activities  Adapted Vestibular Activities based on principle of Vestibular Rehabilitation will be trained to caregiver. Researcher and caregiver will provide intervention 6days/week for 4 weeks, twice a day. Total of 48 session with each session of 60 minutes will be given. The intervention will be provided at Room No.24, A block, Chettinad School of Occupational Therapy, Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education, Rajiv Gandhi Salai, OMR, Kelambakkam, Chennai, Tamilnadu,India, 603103 
Comparator Agent  Time Up and Go Test (TUG)  At the beginning and followed by 4 weeks of intervention completion fall risk will be assessed using TUG Test. The test will be conducted at Room No.24, A block, Chettinad School of Occupational Therapy, Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education, Rajiv Gandhi Salai, OMR, Kelambakkam, Chennai, Tamilnadu,India, 603103 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  -Patients who are diagnosed with vestibulopathy
- Both gender (Male & Female) The patients age group between 60-85 years.
- Participants who can regularly follow
interventions.  
 
ExclusionCriteria 
Details  - Undiagnosed vestibulopathy patient
- Patients whose age is below 60 yrs and above 85 yrs
- Patients having any other neurological degenerative disorder
- Patient underwent any spine, hip or knee surgery - Any other medical conditions severe in
nature 
 
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 
Time Up and Go Scale (TUG)  At the beginning followed by on completion of 4 weeks of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
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
Modification(s)  
Phase 1/ Phase 2 
Date of First Enrollment (India)   01/07/2025 
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="0"
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  
Vestibulopathy, characterized by dysfunction of the vestibular system, often results in clinical symptoms such as dizziness, imbalance, unsteady gait, and an increased risk of falls (Smith et
al., 2020). This condition may arise from a variety of etiologies, including vestibular neuritis, Meniere’s disease, bilateral vestibular loss, and central vestibular disorders (Jones et al., 2019).
In older adults and individuals with neurological comorbidities, vestibulopathy significantly contributes to fall risk, leading to diminished independence, reduced quality of life, and
heightened healthcare costs due to fall-related injuries (Lee et al., 2021). The vestibular system, working in close coordination with the visual and proprioceptive systems, is essential for
maintaining postural control and spatial orientation (Chen et al., 2018). When this system is impaired, the brain’s ability to integrate sensory input for balance is disrupted. Conventional
vestibular rehabilitation therapy (VRT)—including habituation, gaze stabilization, and balance training—has demonstrated efficacy in improving function (Brown et al., 2020). However, a
notable subset of patients continues to experience instability and recurrent falls, particularly when therapy is not tailored to individual needs or specific environments (Miller et al., 2022).
Emerging research suggests that adapted vestibular exercises—designed to match the patient’s functional level, environmental context, and unique impairment profile—may improve
adherence, increase engagement, and lead to more favorable clinical outcomes (Garcia et al.,2021). However, empirical data assessing their effectiveness in reducing fall risk among
individuals with vestibulopathy remain limited. There is also a need to evaluate how modifications in exercise intensity, sensory conditions, and task complexity affect balance
performance and fall risk. Given the rising prevalence of vestibular disorders, especially in aging populations.
 
Close