| CTRI Number |
CTRI/2025/06/089399 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improving Balance, Reducing Dizziness, and Enhancing Life Quality through Dual Task Exercises in People with Vestibular Problems |
|
Scientific Title of Study
|
Effect of Dual Task Training on balance, dizziness and quality of life in individual with vestibular dysfunction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amruta Ashok Tarkase |
| Designation |
Post Graduate Student |
| Affiliation |
Dr DY Patil College Of Physiotherapy |
| Address |
Department Of Neuro physiotherapy ,Dr DY Patil College Of Physiotherapy Sant Tukaram Nagar Pimpri Pune 411018 Maharashtra India
Pune
MAHARASHTRA
411018
India |
| Phone |
9307823216 |
| Fax |
|
| Email |
amrutatarkase12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Gagbare Phd |
| Designation |
Professor |
| Affiliation |
Dr DY Patil College Of Physiotherapy |
| Address |
Department Of Neuro physiotherapy ,Dr DY Patil College Of Physiotherapy Sant Tukaram Nagar Pimpri Pune 411018 Maharastra India
Pune
MAHARASHTRA
411018
India |
| Phone |
9096116134 |
| Fax |
|
| Email |
preeti.gazbare@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Amruta Ashok Tarkase |
| Designation |
Post Graduate Student |
| Affiliation |
Dr DY Patil College Of Physiotherapy |
| Address |
Department Of Neuro physiotherapy, Dr DY Patil College Of Physiotherapy Sant Tukaram Nagar Pimpri Pune 411018 Maharashtra India
Pune
MAHARASHTRA
411018
India |
| Phone |
9307823216 |
| Fax |
|
| Email |
amrutatarkase12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018 |
|
|
Primary Sponsor
|
| Name |
Amruta Ashok Tarkase |
| Address |
Dr. D. Y. Patil College of Physiotherapy,Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018 |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 Amruta Ashok Tarkase |
Dr. D. Y. Patil College of Physiotherapy Out Patient Department |
Out Patient Department, Sant Tukaram Nagar Pimpri Pune 411018 Maharastra India
Pune
MAHARASHTRA |
9307823216
amrutatarkase12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Dual Task Training with Vestibular Rehabilitation |
The intervention consists of a four-week dual-task balance training program integrating both motor and cognitive tasks to improve postural control and cognitive-motor coordination. In Week 1 (Basic Level), exercises include standing balance while counting aloud from 1 to 10, head turns while naming five objects, heel raises near a wall while naming three colors, sit-to-stand transitions while counting backward from 10, and straight-line heel-to-toe walking while pronouncing five words starting with the letter "B", all performed in sets and repetitions with short holds. Week 2 (Tandem Movements) introduces more challenging tasks such as tandem stance while naming five objects in the room, tandem walking while naming an animal with each step, heel raises while subtracting numbers backward from 20 to 0 by twos, side-to-side head turns while reciting rhymes, and faster sit-to-stand movements while recalling ten kitchen items. Week 3 (Single-Leg Balance) focuses on more dynamic stability tasks like sit-to-stand while counting backward from 15, obstacle walking while naming a body part per step, heel raises while naming five fruits, single-leg standing with wall support while counting from 1 to 10, and picking up small objects from the floor while standing on one leg and naming the color of each object. Week 4 (Functional Level) targets real-life balance challenges through sit-to-stand from a lower surface while naming five family members, walking with an object (like a tray) while naming fruits with each step, single-leg balance while reciting rhymes, straight-line walking while saying five words starting with the letter “P”, and reaching forward to pick objects while counting each one aloud. The exercises are progressive in difficulty each week and combine cognitive engagement with balance and strength movements to simulate functional tasks. Each session includes 2–3 sets of 5–10 repetitions or time-based holds as indicated. This protocol aims to enhance balance, reduce fall risk, and improve dual-task performance through structured training.
total duration of treatment-4 weeks
|
| Comparator Agent |
vestibular rehabilitation |
Conventional vestibular Rehabilitation |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Pre Diagnosed cases of vestibular dysfunction by physician.
2 Able to walk independently with or without a cane.
3 Ability to perform the commands.
4 Middle-aged individuals (40 to 65 years) and above.
5 AMER Dizziness Diagnostic scale for Dizziness score between 5 to 19.
6 Tandem standing balance test 10 to 29 sec.
|
|
| ExclusionCriteria |
| Details |
1 Severe musculoskeletal or neurological disorders (severe osteoarthritis)
2 Recent surgery affecting balance training programs.
3 Severe, untreated visual impairment.
4 Pregnancy.
5 History of recent falls or fractures.
6 History of significant psychiatric disorders (schizophrenia, severe depression)
7 No use of drugs that affect balance in the past 48 h.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mini Balance Evaluation Systems test
Dizziness Handicap Inventory (DHI)
Vestibular Activities of Daily Living Scale (VADL)
|
baseline assessment and post intervention assessment after 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/07/2025 |
| Date of Study Completion (India) |
01/01/2026 |
| Date of First Enrollment (Global) |
07/07/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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
|
This randomized controlled trial aims to evaluate the effect of dual-task training on balance, dizziness, and quality of life in individuals with vestibular dysfunction. Thirty-six participants aged 40–65 years, diagnosed with vestibular dysfunction, will be randomly assigned to either a control group receiving conventional vestibular rehabilitation or an experimental group receiving dual-task training combined with vestibular rehabilitation. The intervention will be conducted over 4 weeks, 3 sessions per week (12 sessions total). Outcome measures will assess changes in balance, dizziness, and quality of life using validated tools. The study intends to determine whether integrating cognitive and motor tasks enhances rehabilitation outcomes more effectively than conventional approaches. |