| CTRI Number |
CTRI/2025/02/080117 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see the effect of 6 week Rehabilitation protocol on Balance and Dizziness in individuals with Vertigo |
|
Scientific Title of Study
|
Effect of 6 week Benign Paroxysmal Positional Vertigo Rehabilitation Protocol On Balance And Dizziness in Individuals with Benign Paroxysmal Positional Vertigo - A Pre Post Experimental Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Janvi Lalani |
| Designation |
PG student |
| Affiliation |
S.S. Agrawal Institue of Physiotherapy and Medical Care Education |
| Address |
neuro opd, ground floor, s.s. Agrawal institute of physiotherapy, Agrawal college campus, verranjali Marg 1, devina park, Navsari.
Navsari
GUJARAT
India
Navsari
GUJARAT
396445
India |
| Phone |
8320886627 |
| Fax |
|
| Email |
janvilalani7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagruti Patel |
| Designation |
Assistant Professor, PG Guide and Phd Scholar |
| Affiliation |
S.S. Agrawal Institue of Physiotherapy and Medical Care Education |
| Address |
neuro opd, ground floor, s.s. Agrawal institute of physiotherapy, Agrawal college campus, verranjali Marg 1, devina park, Navsari.
Navsari
GUJARAT
396445
India |
| Phone |
9974661767 |
| Fax |
|
| Email |
jagukpatel57@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Janvi Lalani |
| Designation |
PG student |
| Affiliation |
S.S. Agrawal Institue of Physiotherapy and Medical Care Education |
| Address |
neuro opd, ground floor, s.s. Agrawal institute of physiotherapy, Agrawal college campus, verranjali Marg 1, devina park, Navsari.
Navsari
GUJARAT
396445
India |
| Phone |
8320886627 |
| Fax |
|
| Email |
janvilalani7@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.S. Agrawal Institute of physiotherapy and medical care Education, Navsari Gujarat. 396445 |
|
|
Primary Sponsor
|
| Name |
Janvi Lalani |
| Address |
32, Raj Laxmi Society Parmesh Diamond Road, Chhapra, Navsari. 396445, Gujarat, India |
| Type of Sponsor |
Other [] |
|
|
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 Shlesha Vaidya |
s.s.agrawal institute of physiotherapy and medical care education, navsari |
Department of
physiotherapy,ground
floor, Agrawal College
campus, Viranjali van
marg, Devina park,
navsari
Navsari
GUJARAT
Navsari
GUJARAT |
9427285250
drsmvaidya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee of S.S.Agrawal College Of Physiotherapy And Medical Care Education. |
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 |
| Intervention |
Exercise Therapy |
In Week 1, the program includes cervical manual traction performed in 3 sets of 10-second holds, 5 days per week. Cervical muscle release involves stretching the upper trapezius, levator scapulae, sternocleidomastoid, and scalene muscles, with 3 sets of 30-second holds, 5 days per week. Gaze stability exercises are performed for 1 to 2 minutes, five times a day. Additionally, the Brandt-Daroff exercise is completed with 2 repetitions.
In Week 2, cervical manual traction progresses to 5 sets of 20-second holds, 5 days per week. Cervico-occipital muscle release involves stretching the same muscle groups as Week 1, but with 5 sets of 30-second holds, 5 days per week. Gaze stability exercises increase to 3 to 5 minutes, five times a day. The Brandt-Daroff exercise is performed with 3 repetitions.
During Week 3, gaze stability exercises further increase to 5 to 7 minutes, five times a day. The Brandt-Daroff exercise progresses to 4 repetitions and is continued until the patient experiences no vertigo. Apley’s maneuver is introduced with 3 repetitions.
In Week 4, Apley’s maneuver progresses to 4 repetitions, and the Brandt-Daroff exercise increases to 5 repetitions. Balance training is introduced at Stage 1-2.
In Week 5, balance training progresses to Stage 3-4, and Apley’s maneuver is performed with 5 repetitions.
Finally, in Week 6, balance training advances to Stage 5-7, and Apley’s maneuver is performed with 6 repetitions.
|
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
• Individuals diagnosed with BPPV by ascertained qualified medical professionals.
• Age more than 18 years.
• Stable medical condition.
• VVAS
• MMSE more than or equal to 24
• BBS (3 |
|
| ExclusionCriteria |
| Details |
1.neurological deficit other than BPPV.
2. Previous Brain or Cervical injury
3. Perceptual, visual and auditory deficits |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gujarati version of ABC scale for Balance |
Baseline and at 6 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gujarati version of Dizziness Handicap Inventory |
Baseline and at 6 week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/02/2025 |
| 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="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
|
AIM AND OBJECTIVE: • AIM : To know the effect of a 6-week Benign Paroxysmal Positional Vertigo rehabilitation protocol on balance and dizziness in patients with BPPV. • Objective: 1) To know the effect of a 6-week Benign Paroxysmal Positional Vertigo rehabilitation protocol on balance in patients with BPPV. 2) To know the effect of a 6-week Benign Paroxysmal Positional Vertigo rehabilitation protocol on dizziness in patients with BPPV. |