| CTRI Number |
CTRI/2024/07/071358 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
to check the effect of gufoni maneuver on balance and quality of life in bppv patients |
|
Scientific Title of Study
|
EFFECT OF GUFONI MANEUVER ON BALANCE AND QUALITY OF LIFE IN HORIZONTAL CANAL 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 |
Sakshi Heda |
| Designation |
Post graduate student |
| Affiliation |
KAHER Institute of physiotherapy |
| Address |
Advanced Physiotherapy centre, Room no.39, Sagar floor, Kles Dr. Prabhakar Kore Hospital and MRC.
Belgaum
KARNATAKA
5900010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
8310777823 |
| Fax |
|
| Email |
sakshiheda99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjiv kumar |
| Designation |
principal and professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy centre, Room no.39, Sagar floor, Kles Dr. Prabhakar Kore Hospital and MRC.
Belgaum
KARNATAKA
5900010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9448745648 |
| Fax |
|
| Email |
sanjiv3303@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sakshi Heda |
| Designation |
Post graduate student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy centre, Room no.39, Sagar floor, Kles Dr. Prabhakar Kore Hospital and MRC.
Belgaum
KARNATAKA
5900010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
8310777823 |
| Fax |
|
| Email |
sakshiheda99@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE DR. PRABHAKAR KORE HOSPITAL and MRC
nehru nagar,
belgaum, karnataka
590010 |
|
|
Primary Sponsor
|
| Name |
Sakshi heda |
| Address |
Advanced Physiotherapy centre, Room no 39, Sagar floor, Kle Dr.
Prabhakar Kore Hospital and MRC
nehru nagar,
belgaum,
karnataka
590010 |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 |
| Sakshi Heda |
KLE Dr. Prabhakar Kore Hospital |
Sagar floor,Advanced
Physiotherapy centre,
Room no.39, KLE Dr.
Prabhakar Kore
Hospital and MRC.
Belgaum
KARNATAKA
590010
Belgaum
KARNATAKA |
8310777823
sakshiheda99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific and ethics committee, KAHER Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
horizontal canal bppv |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
gufoni maneuver |
In the Gufoni maneuver, the patient is sitting looking straight and is then moved quickly so that the patient lies on one side (on the healthy side for a geotropic case, on the affected side for an apogeotropic case). After lying in this position for 2 minutes, the patient turns the head down by 45 degrees, maintaining this position for 2 more minutes, and then is returned to a sitting position.
Repeat the maneuver 4 times per session
4 sessions- 2 times per week
for 2 weeks |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed horizontal canal BPPV patients of both genders in age group 18 to 70 years
2. Supine roll test positive
3. Score on Activities Specific Balance Confidence Scale less than 80percent
4. Onset of vertigo more than 3months prior
|
|
| ExclusionCriteria |
| Details |
1. Any type of vertigo other than horizontal canal BPPV
2. History of spinal problems like spondylitis
3. Neck or head trauma in the past
4. History of neurological or psychiatric disorders.
5. Impaired cognition
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Activities specific balance confidence scale
Dizziness handicap inventory
|
baseline and 2 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Benign paroxysmal positional vertigo (BPPV) is a common peripheral vestibular condition, with horizontal canal BPPV being more common than previously reported. Patients with BPPV have impaired balance ability, increased disability, and longer symptoms. The Gufoni maneuver, designed to reposition displaced otoconia within the semicircular canals of the inner ear, has emerged as a potential treatment option. However, there is a lack of evidence supporting its efficacy and impact on balance and quality of life. The study aims to evaluate the effect of the Gufoni maneuver on balance and quality of life in participants with horizontal canal BPPV, as it could potentially improve daily functioning and overall well-being. |