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CTRI Number  CTRI/2025/03/082004 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 06/03/2025
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 effect of Tai Chi and Cawthorne-Cooksey Exercises on Balance and Gait in Patients with Benign Paroxysmal Positional Vertigo 
Scientific Title of Study   Effect of Taichi versus Cawthorne Cooksey exercises on balance and gait in patients with benign paroxysmal positional vertigo 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sayyad Shefa Kubra 
Designation  MPT Student 
Affiliation  Sunandan Divatia School Of Science 
Address  Department of Physiotherapy Ground Floor Nanavati Max Super Specialty Hospital SV Road Vile parle (W)

Mumbai
MAHARASHTRA
400056
India 
Phone  6306613303  
Fax    
Email  Sayedshefa09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sabah Thaver  
Designation  Assistant Professor - Physiotherapist 
Affiliation  Sunandan Divatia School Of Science 
Address  Sunandan Divatia School of Science Department Of Physiotherapy 7th floor mithibai College Building Bhaktivedanta Road Vile Parle (west)

Mumbai
MAHARASHTRA
400056
India 
Phone  9820691076  
Fax    
Email  Sabah.Thaver@nmims.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sabah Thaver  
Designation  Assistant Professor - Physiotherapist 
Affiliation  Sunandan Divatia School Of Science 
Address  Sunandan Divatia School of Science Department Of Physiotherapy 7th floor mithibai College Building Bhaktivedanta Road Vile Parle (west)

Mumbai
MAHARASHTRA
400056
India 
Phone  9820691076  
Fax    
Email  Sabah.Thaver@nmims.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Ground Floor, Nanavati Max Super Specialty Hospital, SV Road, Vile parle (W), Mumbai-4000056 
 
Primary Sponsor  
Name  None 
Address  NA 
Type of Sponsor  Other [NIL] 
 
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 Ali Irani  Nanavati Max Super Speciality Hospital  Department of Physiotherapy, Ground Floor, Nanavati Max Super Specialty Hospital, SV Road, Vile parle (W)
Mumbai
MAHARASHTRA 		 02261347560

physiodept.nanavati@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nanavati Max Super Specialty Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H811||Benign paroxysmal vertigo,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cawthorne Cooksey Exercises  It is a 4 week intervention with total 12 sessions- 3 session per week (alternate days) 
Intervention  Tai Chi  It is a 4 week intervention with total 12 sessions- 3 session per week (alternate days) 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Adults with vertigo by a medical practitioner, who have undergone correction, but show residual symptoms which include dizziness/ light headedness on movement.
Adults with intact cognition and communication
 
 
ExclusionCriteria 
Details  Any medical condition and injury that would hamper balance.
Any other co-existing neurological condition.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Functional Gait Assessment  Baseline and post 4 week of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Four Square Step Test  Baseline and post 4 week of intervention 
Time Up and Go Test  Baseline and post 4 week of intervention 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   17/03/2025 
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="6"
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  

 Introduction:Benign Paroxysmal Positional Vertigo (BPPV) is a common vestibular disorder causing brief vertigo episodes due to dislodged otolithic debris in the semicircular canals. It primarily affects older adults, especially women, and significantly impacts balance, mobility, and quality of life.

Rationale:BPPV disrupts balance and increases fall risk. While repositioning maneuvers are the primary treatment, additional interventions are needed. Tai Chi enhances balance, coordination, and strength, but its effectiveness in BPPV remains unexplored.

Aim:To compare the effects of Tai Chi and Cawthorne-Cooksey exercises on balance and gait in BPPV patients.

Objectives:

Assess the effect of Tai Chi on balance and gait in BPPV patients.

Assess the effect of Cawthorne-Cooksey exercises on balance and gait in BPPV patients.

Compare outcomes between the two groups.

Outcome Measures:

Four Square Step Test – Assesses dynamic stability and coordination

Timed Up and Go Test – Evaluates mobility.

Functional Gait Assessment – Measures postural stability and balance during walking.

Protocols:

Cawthorne-Cooksey Exercise Protocol

  1. Frequency: 3 times per week for 4 weeks (12 sessions).
  2. Duration: Starts with a few seconds, progressing to 1-2 minutes per exercise.
  3. Intensity: Mild to moderate dizziness (4-6/10); stop if symptoms resolve.
  4. Exercises: Eye, head, shoulder, standing balance, and mobility exercises, progressing from seated to dynamic movements, including walking with eyes open/closed.

Tai Chi Exercise Protocol

1. Frequency: 3 times per week for 4 weeks (12 sessions).

2. Duration: 40-45 minutes per session

3. Intensity: Low to moderate, slow controlled movements

4. Exercises: Balance-focused Tai Chi movements, progressively increasing repetitions from 5 to 12 (3 sets)

 
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