| CTRI Number |
CTRI/2025/12/098271 [Registered on: 01/12/2025] Trial Registered Prospectively |
| Last Modified On: |
29/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect Of Vestibular Intervention On Vertigo In Patients With Cervical Radiculopathy on balance, dizziness and disabilty |
|
Scientific Title of Study
|
Effect Of Vestibular Intervention On Vertigo In Patients With Cervical Radiculopathy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Khushboo |
| Designation |
PG Student |
| Affiliation |
Amity Institute Of Health And Allied Sciences |
| Address |
Room no. 5 lower ground floor F1 block, Department of Physiotherapy, Amity Institute of Health Allied Sciences. Amity University, Noida , Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
8826311354 |
| Fax |
|
| Email |
khushbooguptadkg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchika Kalra |
| Designation |
Teaching Associate |
| Affiliation |
Department of Physiotherapy, Amity Institute of health and allied sciences |
| Address |
Room no. 5 lower ground floor F1 block, Department of Physiotherapy, Amity Institute of Health Allied Sciences. Amity University, Noida , Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
9718417185 |
| Fax |
|
| Email |
rkalra1@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidhi Jain PT |
| Designation |
Senior Physiotherapist |
| Affiliation |
Vinayak Hospital Noida. |
| Address |
Room no. 1, First floor Department of Physiotherapy Vinayak Hospital Pocket E Sector 27 Noida Uttar Pradesh 201301
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
9582437144 |
| Fax |
|
| Email |
vidhij.physio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no. 1 , First floor Department of Physiotherapy Vinayak Hospital Pocket E Sector 27 Noida Uttar Pradesh This Department Will Provide A Platform For Data Collection |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Ms Khushboo |
Vinayak Hospital Department Of Physiotherapy |
Room no. 1, First floor Department of Physiotherapy Vinayak Hospital Pocket E Sector 27 Noida Uttar Pradesh 201301
Gautam Buddha Nagar
UTTAR PRADESH |
9911463409
-
khushbooguptadkg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Not Applicable |
No Objection Certificate |
| NTCC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G542||Cervical root disorders, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A Control Group |
Group A Control Group
Group A Receives Tens With Frequency Of Five Hertz And High Intensity With A Pulse Duration Of Three Hundred Microseconds For Twenty Minutes Five Times In A Week Electrodes Are Placed On The Area Of Greatest Pain The Treatment Includes Cervical Muscle Isometric Exercises Soft Tissue Mobilization Deep Neck Flexor Strengthening Stretching Of Trapezius Scalene And Sternocleidomastoid Muscles Pectoralis Stretching Nerve Slider Techniques And Strengthening Exercises. Each Session Lasts Forty Five Minutes For Five Days In A Week
|
| Intervention |
Group B Experimental Group Of Vestibular Rehabilitation |
Group B Experimental Group
Group B Receives Conventional Treatment Along With Vestibular Rehabilitation. The Program Includes Tens Active And Passive Exercises Strengthening Exercises And Active Mobilization For Five Days In A Week For Six Weeks Vestibular Rehabilitation Consists Of Cawthorne Cooksey Exercises Eye And Head Movements Sitting And Standing Tasks Balance Activities Tossing Ball Exercises Walking With Head Turns Single Leg Stance Walking On Soft Surfaces Eyes Closed Walking In Room Each Session Lasts Forty Five Minutes Three Times In A Week For Six Weeks
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age 25-40,Patients with consent form ,population Diagnosed case of with cervical Radiculopathy, Patient should complaint of neck pain with vertigo or dizziness,Pain range less than 5 on NPRS,Vertigo ranges 0-1 by MVS.
|
|
| ExclusionCriteria |
| Details |
Non case of cervical radiculopathy.
Any neurological conditions.
Patient on BPPV medicines
No Inner Ear Pathology.
Patient with any cranial nerve injury.
Patient with traumatic brain injury.
Patient with any neck surgery.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dizziness Handicap Inventory Scale, Visual Vertigo Analogue Scale, Romberg Test, Y-balance Test, |
For 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neck Disability Test, Numeric Pain Rating Scale |
For 6 Weeks |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
10/12/2025 |
| 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="0"
Months="3"
Days="5" |
|
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
|
This Experimental Study Aims To Evaluate The Effect
Of Vestibular Intervention On Vertigo, Balance, And Disability In
Patients Diagnosed With Cervical Radiculopathy Who Also
Experience Dizziness Or Vertigo. A Total Of 46 Participants Aged from 25 to 40
Years Will Be Recruited Through Convenient Sampling In Delhi With 23 Participants In Each Group, As Calculated By G Power .Eligible Participants Will Include Adults With Cervical
Radiculopathy Who Report Neck Pain as Less Than 5 On NPRS And Mild Vertigo . Individuals With Neurological Disorders, Cranial Nerve Injury,
Traumatic Brain Injury, BPPV Medications, Or A History Of Neck Surgery Will Be
Excluded.
|