| 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
|
|
|
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
|
|
|
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
|
|
|
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. |