| CTRI Number |
CTRI/2021/04/033164 [Registered on: 27/04/2021] Trial Registered Prospectively |
| Last Modified On: |
26/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Role of balancing exercises in vertigo |
|
Scientific Title of Study
|
Role of Postural Stability exercises in management of Benign Paroxysmal Positional Vertigo |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhakti Kotak |
| Designation |
Clinical Physiotherapist |
| Affiliation |
Gokul Hospital. OPD no 5 |
| Address |
A-41, Indra Palace, Opp. Sheth laboratory, Sardarnagar 5, Astron Chowk, Rajkot-01
12-14 Manhar plot, Vidyanagar main road, Bhaktinagar, Rajkot-01
Rajkot
GUJARAT
360001
India |
| Phone |
9898808792 |
| Fax |
|
| Email |
kotakbhakti@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhakti Kotak |
| Designation |
Clinical Physiotherapist |
| Affiliation |
Gokul Hospital |
| Address |
A-41, Indra Palace, Opp. Sheth laboratory, Sardarnagar 5, Astron Chowk, Rajkot-01
12-14 Manhar plot, Vidyanagar main road, Bhaktinagar, Rajkot-01
Rajkot
GUJARAT
360001
India |
| Phone |
9898808792 |
| Fax |
|
| Email |
kotakbhakti@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhakti Kotak |
| Designation |
Clinical Physiotherapist |
| Affiliation |
Gokul Hospital |
| Address |
A-41, Indra Palace, Opp. Sheth laboratory, Sardarnagar 5, Astron Chowk, Rajkot-01
12-14 Manhar plot, Vidyanagar main road, Bhaktinagar, Rajkot-01
Rajkot
GUJARAT
360001
India |
| Phone |
9898808792 |
| Fax |
|
| Email |
kotakbhakti@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Gokul Hospital, 12-14 Manhar PLot, Vidyanagar Main road,Bhaktinagar, Rajkot-01 |
|
|
Primary Sponsor
|
| Name |
Bhakti Kotak |
| Address |
Gokul Hospital,Opd no 5 12-14 Manhar PLot, Vidyanagar Main road,Bhaktinagar, Rajkot-01 |
| 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 |
| Bhakti Kotak |
Gokul Hospital. OPD no 5 |
12-14 Manhar Plot, Vidyanagar main road, Bhaktinagar, Rajkot-01
Rajkot
GUJARAT |
9898808792
kotakbhakti@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree Giriraj Hospital Research Ethics Commitee |
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 |
1.Particle repositioning maneuvers |
1. Particle repositioning maneuvers like Epleys, Liberatory, or barbeque roll as per the direction and canal involvement in the Dix hall pike test and the supine Roll test. This would be performed on the first day of treatment and thereafter after 48 hours if required. |
| Comparator Agent |
1.Postural stability exercises. |
Postural stabililty exercises in form of progressively challenging Base of support, external support, visual inputs and somatosensory inputs in standing, walking and sitting position. This exercises would be performed for 20 minutes twice daily for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
•Fits into clinical diagnosis of BPPV: Positive Dix-hall pike test or supine roll test with clear and classical features of positional nystagmus.
•Can perform bedside transfer like rolling, getting up from bed and moving around independently.
|
|
| ExclusionCriteria |
| Details |
•Previous or current diagnoses of labyrinthine diseases such as Meniere’s disease, labyrinthitis or vestibular neuronitis.
•Contraindications to repositioning maneuvers: any cervical spine problems limiting its mobility for the procedure like e.g. stenosis, severe kyphoscoliosis, advanced rheumatoid arthritis, cervical radiculopathies, systemic bone disorders like Paget’s, Ankylosing spondylitis, severe lumbar dysfunction, spinal cord injuries etc.
•Disorders of central nervous system: Central vertigo
•Patient refusal to participate in the study.
•Other causes which may hinder the understanding of the objectives and methodology of the study (poor comprehension or language barrier etc.). |
|
|
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 |
1.Modified Clinical Test of Sensory interaction of Balance
2. Modified Dynamic Gait Index.
3. Dizziness Handicap Inventory |
1. On day of examination
2. 1 week after treatment
3. 1 month after treatment
4. 3 months after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Modified Clinical Test of Sensory interaction of Balance
2. Modified Dynamic Gait Index.
3. Dizziness Handicap Inventory |
1. On day of examination
2. 1 week after treatment
3. 1 month after treatment
4. 3 months after treatment |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/05/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Benign
paroxysmal positional vertigo (BPPV) is a mechanical problem of peripheral
vestibular system resulting from otoconia being displaced into the semicircular
canals or otoconia being adhered to the cupulla ampullaris. It represents the most
common etiology of vertigo and 1% of all patient visits to a physician. It comprises
18.75% of total patients coming to outdoor department with complaint of vertigo
due to various reasons in Gujarat. Characterized by brief
episodes of vertigo, with perception of either the environment or one’s self
spinning when the head is moved in certain position. Patients report that
vertigo is triggered by lying down, rolling over in bed, getting out of the bed, bending
down or looking upward. It is the most
common cause of recurrent and episodic vertigo from peripheral vestibular disorder. Other
associated complaints include problems in balance that may last for hours or
days after the episode of vertigo has stopped and more vague sensation of
lightheadedness or feeling of floating. Spontaneous remission of
this condition is common. For those whom
episodic vertigo persists, this disorder can be annoying, disruptive and often
results in significant changes in normal activities. There are good
evidences of the particle repositioning maneuvers being very effective in
resolving the symptoms of BPPV. Epley’s maneuver for canaliathiasis and Semont’s or Liberatory maneuver for cupulolithiasis are effective
in diminishing vertigo and Brandt-Daroff exercises as habituation exercise for
less symptomatic patients. After BPPV has
been successfully treated and spinning symptoms resolved, some patients will
continue to report non-specific dizziness (symptoms other than spinning) and/or
imbalance. BPPV represented
the most prevalent diagnosis on the population studied (43.8%) as most common
reason of falls. Most of the
studies have examined the effectiveness of one or more maneuver or compared the
various maneuver along with the rates of emission as an outcome measures. There seems to be
insufficient scientific evidence on effect postural stability exercises or
vestibular rehabilitation as a whole in cases of BPPV . Hence the aims and objectives of this study are as follows: 1.To assess
balance in patients of BPPV. 2.To evaluate short
term and long term effects of adding postural stability exercises to particle
repositioning maneuver in patients of BPPV. 3.To assess the
correlation between the outcome measures of the study i.e. m- CTSIB, m-DGI and
DHI in patients of BPPV |