| CTRI Number |
CTRI/2023/05/053111 [Registered on: 24/05/2023] Trial Registered Prospectively |
| Last Modified On: |
23/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effectiveness of virtual reality based exercises on balance, dizziness, nystagmus and quality of life in patients with posterior canal benign paroxysmal positional vertigo |
|
Scientific Title of Study
|
Therapeutic effectiveness of virtual reality-based exercise through Oculus Quest 2 on balance, dizziness, nystagmus and quality of life in patients with posterior canal benign paroxysmal positional vertigo -A randomized control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shrushti Jachak |
| Designation |
PG Scholar |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research. |
| Address |
Department of neuro-physiotherapy, Room No- 01, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, India.
Wardha
MAHARASHTRA
442001
India |
| Phone |
7507051123 |
| Fax |
|
| Email |
shrushtijachak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghumahanti Raghuveer |
| Designation |
Professor Neuro Physiotherapy Department |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research. |
| Address |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, India.
Wardha
MAHARASHTRA
442001
India |
| Phone |
8126506769 |
| Fax |
|
| Email |
raghuneuro@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shrushti Jachak |
| Designation |
PG Scholar |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research. |
| Address |
Department of Neuro-physiotherapy, Room No- 01, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, India.
Wardha
MAHARASHTRA
442001
India |
| Phone |
7507051123 |
| Fax |
|
| Email |
shrushtijachak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, India. |
|
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Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College |
| Address |
Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, India. |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shrushti Jachak |
Aachrya Vinobha Bhave Rural Hospital, Sawangi (Meghe), Wardha |
Neurophysiotherapy OPD (Unit 2), Room No- 01, Aachrya Vinobha Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, India.
Wardha
MAHARASHTRA |
7507051123
shrushtijachak@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H811||Benign paroxysmal vertigo, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional therapy( Bandt- Droff exercise) |
Subjects will receive 20-min conventional rehabilitation training per day, 12 sessions,3 days a week for 4 weeks.
Bandt-Droff exercise will be given to the patient, with 10 repetitions with break after the cycle of 5 sets. This conventional rehabilitation delivered by a therapist at the hospital. Conventional rehabilitation will be designed with similar intensity and complexity to simulate the skills required in the immersive VR group. The patient will start in a sitting position for the Brandt-daroff exercise and turns the head 45 degrees to one side (left) then quickly lies down on the opposite shoulder (right). Patient should be instructed to remain in this position for 30 sec or until the vertigo stops. The patient then slowly returns to the starting position, maintaining the hear rotation (left) until sitting upright. Next, the patient turns the head to the opposite direction (right) and lied down on the other shoulder (left), observing the similar 30 sec time guidelines. Researchers in the study will supervise and encourage all participants to fully participate in the training to guarantee the quality of the training.
|
| Intervention |
VR based exercise through oculus quest 2 adjunct to conventional therapy |
Virtual reality gaming systems construct a simulation model that gives players the impression that they are in a real world and helps them to communicate with the computer-generated interactive environment. These systems have a computer-generated interactive world. Subjects will receive 20 minutes of conventional rehabilitation and 20 minutes of VR rehabilitation training per day, 12 sessions, 3 days a week for 4 weeks conducted by a therapist at the hospital. The patient will start in a sitting position for the convention treatment and turns the head 45 degrees to one side (left) then quickly lies down on the opposite shoulder (right). Patient should be instructed to remain in this position for 30 sec or until the vertigo stops. The patient then slowly returns to the starting position, maintaining the hear rotation (left) until sitting upright. Next, the patient turns the head to the opposite direction (right) and lied down on the other shoulder (left), observing the similar 30 sec time guidelines. During the daily 20-min VR rehabilitation, subjects in the experimental group will be required to complete the “Coaster Combat†game on a back supported chair in a virtual environment. The time duration of a game is 10 minutes, patient will be asked to play 2 sets of this game. When using the Oculus Quest 2, the patient can look around by physically turning the head to a limited degree. This is close to a realistic experience and provides a high level of immersion. VR game will provide the virtual environment and will eventually boost the level to interest and adherence of patient towards rehabilitation. |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Both Males and Females between 20 to 50 years, diagnosed will positive Loaded Dix-Hallpike test for PC-BPPV.
2. Patients with Dizziness Handicap Inventory score < 52
3. Patients who are willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients with Central vestibular dysfunction, Cerebellar dysfunction, Cognitive impairments, and migraines.
2. Patients with Dizziness Handicap Inventory score ≥ 52
3. Patients with inner ear infections and auditory dysfunctions.
4. Patients under medications.
5. Enrolment in another clinical trial involving physiotherapy or an investigational drug.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1. Berg Balance Scale (BBS)
2. Dizziness Handicap Inventory (DHI)
3. Quality of Life Scale (QOLS)
4. Nystagmus time
|
1. Berg Balance Scale (BBS) at baseline and 4 weeks.
2. Dizziness Handicap Inventory (DHI) at baseline and 4 weeks.
3. Quality of Life Scale (QOLS) at baseline and 4 weeks.
4. Nystagmus time at baseline and 4 weeks.
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Vertigo Symptom Scale Short Form |
At baseline and after 4 weeks |
|
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Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
01/06/2023 |
| 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 |
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Publication Details
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 07-06-2024 and end date provided 12-12-2065?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
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Brief Summary
|
One of the most frequent causes of vertigo, the
abrupt sensation that you are spinning or that the interior of your head is
whirling, is benign paroxysmal positional vertigo (BPPV). Mild to severe
vertigo might appear briefly as a result of BPPV. Virtual reality (VR), in which participants interface with a computer by
moving their bodies, is a novel method of therapy in rehabilitation settings.
It produces a virtual environment in three dimensions using a computer
simulation that affects the user’s senses of sight and sound, creating the
feeling of being lost in it. The aim of the study is
to evaluate the therapeutic effect of oculus quest 2 guided physical therapy in
adjunct to conventional therapy on balance, dizziness, nystagmus and quality of
life in patients with Posterior canal Benign Paroxysmal Positional Vertigo
(PC-BPPV). In this study, 74 subjects will be recruited according to inclusion and exclusion criteria. Participants will be divided into group A (conventional) and group B (interventional). The data will be collected and statistically evaluated. |