| CTRI Number |
CTRI/2025/04/085970 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Impact of balancing exercises on balance and coordination in individuals with Vertigo |
|
Scientific Title of Study
|
Effect of Vestibular and Auditory Exercises on Postural Control and Coordination
Among Individuals with Benign Paroxysmal Positional Vertigo |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Nidhi Sharma |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy & Rehabilitation |
| Address |
Room No. 6, General OPD,Maharishi Markandeshwar Institute of Physiotherapy & Rehabilitation,Maharishi Markandeshwar (Deemed to be University) Mullana, Ambala, Haryana
Ambala
HARYANA
133203
India |
| Phone |
9760835605 |
| Fax |
|
| Email |
sharma.nidhi.physio@mmumullana.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhay Sharma |
| Designation |
Postgraduate Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy & Rehabilitation |
| Address |
Room No. 6, General OPD, Maharishi Markandeshwar Institute of Physiotherapy & Rehabilitation,Maharishi Markandeshwar (Deemed to be University) Mullana, Ambala, Haryana
Ambala
HARYANA
133203
India |
| Phone |
7876070437 |
| Fax |
|
| Email |
abhaysharma0231@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhay Sharma |
| Designation |
Postgraduate Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy & Rehabilitation |
| Address |
Room No. 6, General OPD, Maharishi Markandeshwar Institute of Physiotherapy & Rehabilitation,Maharishi Markandeshwar (Deemed to be University) Mullana, Ambala, Haryana
Ambala
HARYANA
133203
India |
| Phone |
7876070437 |
| Fax |
|
| Email |
abhaysharma0231@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy & Rehabilitation,Maharishi Markandeshwar (Deemed to be University) Mullana, Ambala, Haryana 133203 |
|
|
Primary Sponsor
|
| Name |
Abhay Sharma |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy & Rehabilitation,Maharishi Markandeshwar (Deemed to be University) Mullana, Ambala, Haryana 133203 |
| 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 Abhay Sharma |
Maharishi Markandeshwar Institute of Physiotherapy & Rehabilitation |
Roon No. 6, General OPD, Maharishi Markandeshwar Institute of Physiotherapy & Rehabilitation,Maharishi Markandeshwar (Deemed to be University) Mullana, Ambala, Haryana 133203
Ambala
HARYANA |
7876070437
abhaysharma0231@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Maharishi Markandeshwar Institute of Medical Sciences & Research, Maharishi Markandeshwar (Deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H811||Benign paroxysmal vertigo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Auditory and Vestibular Exercises for BPPV |
Auditory Attention Exercises focus on improving the ability to concentrate on specific sounds while ignoring distractions, such as following a conversation in noisy environments. Auditory-Visual Integration Exercises:- Auditory-Visual Integration Exercises help integrate auditory and visual cues, enhancing overall comprehension, such as matching sounds to visual images or lip-reading with sound. Auditory Discrimination Training:- Auditory Discrimination Training improves the ability to distinguish between similar sounds or words, essential for clear communication, like differentiating between phonemes or tones. Dual-Task Training:- Dual-Task Training involves performing auditory tasks alongside another task (e.g., physical or cognitive) to enhance multitasking abilities. Auditory-Cognitive Exercises:- Auditory-Cognitive Exercises combine auditory processing with cognitive tasks, such as memory or problem-solving, to improve listening skills alongside cognitive functions.
Epley’s Manoeuvre:- Epley’s Manoeuvre is a series of head movements designed to treat benign paroxysmal positional vertigo (BPPV) by repositioning displaced inner ear crystals. Vestibular Habituation Exercises:- Vestibular Habituation Exercises involve repeated exposure to motions or positions that provoke dizziness to help the brain gradually reduce its response to these stimuli. Gaze Stabilization Exercises:- Gaze Stabilization Exercises focus on improving control of eye movements during head motion, helping maintain clear vision while moving. • Brandt- Daroff Exercises:- Brandt-Daroff Exercises are used to treat BPPV by repeatedly moving from a seated to a side-lying position to dislodge inner ear particles and alleviate dizziness. Intervention will be given for 4 days a week for 4 consecutive weeks. |
| Comparator Agent |
Auditory Exercises for BPPV |
Auditory Attention Exercises focus on improving the ability to concentrate on specific sounds while ignoring distractions, such as following a conversation in noisy environments. Auditory-Visual Integration Exercises:- Auditory-Visual Integration Exercises help integrate auditory and visual cues, enhancing overall comprehension, such as matching sounds to visual images or lip-reading with sound. Auditory Discrimination Training:- Auditory Discrimination Training improves the ability to distinguish between similar sounds or words, essential for clear communication, like differentiating between phonemes or tones. Dual-Task Training:- Dual-Task Training involves performing auditory tasks alongside another task (e.g., physical or cognitive) to enhance multitasking abilities. Auditory-Cognitive Exercises:- Auditory-Cognitive Exercises combine auditory processing with cognitive tasks, such as memory or problem-solving, to improve listening skills alongside cognitive functions
Intervention will be given for 4 days a week for 4 consecutive weeks. |
| Intervention |
Vestibular Exercises for BPPV |
Epley’s Manoeuvre:- Epley’s Manoeuvre is a series of head movements designed to treat benign paroxysmal positional vertigo (BPPV) by repositioning displaced inner ear crystals.
Vestibular Habituation Exercises:- Vestibular Habituation Exercises involve repeated exposure to motions or positions that provoke dizziness to help the brain gradually reduce its response to these stimuli.
Gaze Stabilization Exercises:- Gaze Stabilization Exercises focus on improving control of eye movements during head motion, helping maintain clear vision while moving.
•
Brandt- Daroff Exercises:- Brandt-Daroff Exercises are used to treat BPPV by repeatedly moving from a seated to a side-lying position to dislodge inner ear particles and alleviate dizziness.
Intervention will be given for 4 days a week for 4 consecutive weeks. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Adults ages 30 to 50 years
Participants willing to participate
Diagnosed with BPPV
No prior vestibular rehabilitation in the past 6 months
Both male and female gender
Mini-BESTest less than twenty-two
Visual Vertigo Analog Scale (VVAS) greater than two |
|
| ExclusionCriteria |
| Details |
History of neurological disorders
Patients with secondary BPPV
Cerebrovascular disease
Systemic illness
Refusal to participate in the study
Conditions contraindicating physical therapy
Severe cognitive impairment
Other vestibular disorders example Menieres disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mini BESTest
Tandem Gait Test |
Measure at the baseline (o day) and at the end of the 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Dizziness Handicap Inventory
Visual Vertigo Analog Scale |
Measure at the baseline (o day) & at the end of the 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
26/05/2025 |
| 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="1"
Months="6"
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
|
Background: Benign Paroxysmal Positional Vertigo (BPPV) is a common vestibular disorder that affects balance and spatial orientation, leading to dizziness and impaired postural control. Participants with BPPV will undergo a structured exercise program, and pre and post intervention assessments will measure their postural sway, coordination, and quality of life. Sudden sensorineural hearing loss (SSNHL) accompanied by benign paroxysmal positional vertigo (BPPV) is relatively common. There are unified standards for the treatment of primary BPPV with good reduction effect, while there are few studies on the treatment of BPPV secondary to SSNHL. Purpose: To determine the effect of Vestibular and Auditory Exercises on Postural Control and Coordination among individuals with Benign Paroxysmal Positional Vertigo Methods: 36 Participants will be recruited who will be randomly divided into 3 equal groups with 12 participants in each group on the basis of inclusion and exclusion criteria. For four weeks, the group 1 will receive active Auditory exercises while the group 2 will receive Vestibular exercises and the 3rd group will receive both auditory and vestibular exercises. Outcome measures like the Mini BESTest, TUG (Timed Up and Go Test), DHI (Dizziness Handicap Inventory), Tandem Gait Test (Heel-to-Toe Walking), 6 minutes’ walk test will be used to assess the subject pre-intervention and post-intervention. Intervention will be given for 4 days a week for four weeks. Data Analysis: Shapro-wilk test will be used to establish the normality of the data. If the data is found to be normally distributed, parametric tests will be used. If the data is not found to be normally distributed, then non-parametric tests are used. |