| CTRI Number |
CTRI/2024/04/065693 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECT OF EXERCISE PROGRAM VERSUS VIRTUAL REALITY ON BALANCE AND GAIT IN PATIENTS WITH PERIPHERAL VERTIGO - |
|
Scientific Title of Study
|
EFFECT OF THE OTAGO EXERCISE PROGRAM VERSUS VIRTUAL REALITY BASED CAWTHORNE COOKSEY EXERCISES ON BALANCE AND GAIT IN PATIENTS WITH PERIPHERAL VERTIGO- A RANDOMISED CLINICAL TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JEMIMAH JOHN DAVID |
| Designation |
STUDENT |
| Affiliation |
KLE INSTITUTE OF PHYSIOTHERAPY BELGAUM |
| Address |
ADVANCED PHYSIOTHERAPY CENTRE ,ROOM NO 39, KLE Dr. PRABHAKAR KORE HOSPITAL AND MRC BELGAUM,KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
07021197396 |
| Fax |
|
| Email |
jemimahjohndavid@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. SANJIV KUMAR |
| Designation |
PRINCIPAL AND PROFESSOR |
| Affiliation |
KLE INSTITUTE OF PHYSIOTHERAPY BELGAUM |
| Address |
ADVANCED PHYSIOTHERAPY CENTRE ,ROOM NO 39, KLE Dr. PRABHAKAR KORE HOSPITAL AND MRC BELGAUM,KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
9448745648 |
| Fax |
|
| Email |
sanjiv3303@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
JEMIMAH JOHN DAVID |
| Designation |
STUDENT |
| Affiliation |
KLE INSTITUTE OF PHYSIOTHERAPY BELGAUM |
| Address |
ADVANCED PHYSIOTHERAPY CENTRE,ROOM NO 39, KLE Dr. PRABHAKAR KORE HOSPITAL AND MRC BELGAUM,KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
07021197396 |
| Fax |
|
| Email |
jemimahjohndavid@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE DR.PRABHAKAR KORE HOSPITAL |
|
|
Primary Sponsor
|
| Name |
JEMIMAH JOHN DAVID |
| Address |
Advanced Physiotherapy centre, Room no 39, Sagar floor, Kle Dr.
Prabhakar Kore Hospital and MRC. |
| 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 |
| JEMIMAH |
KLE DR. PRABHAKAR KORE HOSPITAL |
Advanced Physiotherapy centre, Room no 39, Sagar floor, Kle Dr.
Prabhakar Kore Hospital and MRC
Belgaum
KARNATAKA |
07021197396
jemimahjohndavid@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SCIENTIFIC AND ETHICS KAHER INSTITUTE OF PHYSIOTHERAPY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G988||Other disorders of nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
OTAGO EXERCISE PROGRAM |
SERIES OF BALANCE EXERCISES ALONG WITH WALKING TO TRAIN BALANCE |
| Comparator Agent |
VR WITH CAWTHORNE COOKSEY EXERCISES |
VR(HEAD MOUNTED) ROLLAR COASTER APPLICATION ALONG WITH CONVENTIONAL CAWTHORNE COOKSEY EXERCISES |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with peripheral vertigo, ambulate independently without support and no change in medications for past 1 month |
|
| ExclusionCriteria |
| Details |
MMSE<25, NEGATIVE DIX HALLPIK TEST, OTHER NEUROLOGICAL IMPAIRMENT AND BALANCE IMPAIRMENT DUE TO OTHER CAUSES |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
DYNAMIC GAIT INDEX AND
BERG BALANCE SCALE |
THE OUTCOME WILL BE TAKEN AT BASELINE, POST 2 WEEKS AND 3 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VERTIGO SYMPTOM SCALE |
BASELINE, 2 WEEKS AND 3 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)
|
25/04/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
participants will be selected according to the inclusion and exclusion criteria and then will be randomly allocated to either of the intervention. baseline assessment and post 2 weeks and 3 weeks re assessment of outcome measures will be done
|