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CTRI Number  CTRI/2024/08/071910 [Registered on: 05/08/2024] Trial Registered Prospectively
Last Modified On: 02/08/2024
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   Comparing two treatments for dizziness related to neck problems 
Scientific Title of Study   A comparative study on effectiveness of epleys maneuver versus vestibular rehabilitation in cervicogenic dizziness 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shreya Saini 
Designation  Post Graduate Student 
Affiliation  Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences 
Address  Shri Mahant Indresh Hospital Department of Physiotherapy North Block, Basement Dehradun UTTARANCHAL 248001 India

Dehradun
UTTARANCHAL
248001
India 
Phone  8279350550  
Fax    
Email  Shreyasaini295@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Niraj Kumar 
Designation  Professor 
Affiliation  Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences 
Address  Shri Mahant Indresh Hospital Department of Physiotherapy North Block, Basement Dehradun UTTARANCHAL 248001 India

Dehradun
UTTARANCHAL
248001
India 
Phone  7895795277  
Fax    
Email  drnirajkumar25@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Niraj Kumar 
Designation  Professor 
Affiliation  Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences 
Address  Shri Mahant Indresh Hospital Department of Physiotherapy North Block, Basement Dehradun UTTARANCHAL 248001 India

Dehradun
UTTARANCHAL
248001
India 
Phone  7895795277  
Fax    
Email  drnirajkumar25@gmail.com  
 
Source of Monetary or Material Support  
Shri Guru Ram Rai University, School of Paramedical And Allied Health Sciences , Pathribagh,Dehradun, Uttarakhand,248001 
 
Primary Sponsor  
Name  Shreya Saini 
Address  Shri Guru Ram Rai University,School of Paramedical and Allied Health Sciences, Pathribagh ,Dehradun, 248001 Health Sciences, Pathribagh ,Dehradun,248001 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shreya Saini  Shri Mahant Indresh Hospital  Room no.-5 Shri Mahant Indresh Hospital, North Block, Patel Nagar, Dehradun
Dehradun
UTTARANCHAL 		 8279350550

Shreyasaini295@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) SHRI GURU RAM RAI INSTITUTE OF MEDICAL AND HEALTH SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Not Applicable 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Epleys maneuver   The Epley maneuver consists of specific head movements that aim to alleviate symptoms of benign positional vertigo, also known as benign paroxysmal positional vertigo (BPPV). The study is 4 days per week for 6 week and 3 sets per day for 10 minutes.  
Comparator Agent  Vestibular rehabilitation   Vestibular rehabilitation (VR), or vestibular rehabilitation therapy (VRT) is a specialized form of therapy intended to alleviate both the primary and secondary problems caused by vestibular disorders. Vestibular rehabilitation therapy (VRT) is an exercise-based treatment program designed to promote vestibular adaptation and substitution. The goals of VRT are 1) to enhance gaze stability, 2) to enhance postural stability 3) to improve vertigo 4) to improve activities of daily living. The study is 4 days per week for 6 week and 3 sets per day for 10 minutes.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  INCLUSION CRITERIA:
1.Age 18- 50 years
2.Both sex groups
3.Neck pain
4.Patients with minimum 10% limitation in range of motion of neck rotation 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA
1.Patient with acute neck pain.
2.Neurological disorders.
3.Orthopaedics disorders.
4.Other systemic disease that may
affect balance.
5. Pregnant woman
5. Pregnant woman 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Neck Disability Index   0-week, 3-week and 6-week  
 
Secondary Outcome  
Outcome  TimePoints 
Berg Balance Scale   0-week, 3-week and 6-week 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/08/2024 
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="0"
Months="0"
Days="4" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response (Others) - 

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 02-07-2024 and end date provided 31-07-2024?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - No
Brief Summary   Cervicogenic Dizziness (CGD) is characterized by dizziness,
imbalance, or instability caused by a problem with the cervical spine, which is usually
accompanied by neck discomfort. Ryan and Cope initially introduced the term
"cervical vertigo" to identify a combination of cervical spine abnormalities and
dizziness. Vertigo caused by changes in neck position is referred to as vertigo
originating in the cervical area. The frequency of dizziness can range from an
unprecedented episode to a steady sensation. Patients experiencing dizziness file a
whole lot of signs and symptoms of various severity. These patients may experience
mental issues, disorientation, depression, anxiety, a worry of open spaces, a lack of
ability to carry out day by day activities.
 
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