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CTRI Number  CTRI/2024/05/067433 [Registered on: 15/05/2024] Trial Registered Prospectively
Last Modified On: 14/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To Check Effect of Virtual Reality Training Along with Conventional Physiotherapy on the Scale of Dyanamic Balance ,Hop Test and Function in Badminton Players having Ankle Instability. 
Scientific Title of Study   Effect of Virtual Reality Training in Adjunct to Conventional Physiotherapy on Dynamic Balance, Hop Test and Function in Badminton Players with Ankle Instability: A Randomized Controlled 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  Dr. Palash Satone 
Designation  Junior Resident 
Affiliation  Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research  
Address  Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (Deemed to be University), Sawangi (Meghe) Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  7507955066  
Fax    
Email  palashsatone27@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Swapnil U Ramteke 
Designation  Professor Department of Sports Physiotherapy 
Affiliation  Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research 
Address  Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research (Deemed to be University), Sawangi (Meghe)

Wardha
MAHARASHTRA
442001
India 
Phone  7619941787  
Fax    
Email  swapnil123.com@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Swapnil U Ramteke 
Designation  Professor Department of Sports Physiotherapy 
Affiliation  Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research 
Address  Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research (Deemed to be University), Sawangi (Meghe)

Wardha
MAHARASHTRA
442001
India 
Phone  7619941787  
Fax    
Email  swapnil123.com@gmail.com  
 
Source of Monetary or Material Support  
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (Deemed to be University), Sawangi Meghe, Wardha-442001, Maharashtra, India. 
 
Primary Sponsor  
Name  Ravi Nair Physiotherapy College 
Address  Department of Sports Physiotherapy, Ravi Nair Physiotherapy College, DMIHER, Sawangi (Meghe), Wardha-442001  
Type of Sponsor  Research institution and hospital 
 
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 Palash Satone  Acharya Vinoba Bhave Rural Hospital, Ravi Nair Physiotherapy College  Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (Deemed to be University) Sawangi Meghe
Wardha
MAHARASHTRA 		 7507955066

palashsatone27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M95||Other acquired deformities of musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BOSUBALL TRAINING  Grade III-IV Mobilization To Talocrural, Subtalar And Midfoot For Pain Control And Mobility for 30 Seconds of Manual Therapy, With 1 Min Rest With 3 Repetition. Utilize Lace Up Brace For Functional Activities As Needed. Gastrocnemius Stretch And Soleus Stretch With 10 Repetitions x 1 set With 20 Seconds Hold. Knee To Wall Closed Chain Dorsiflexion Mobilization With 10 Repetitions × 1 Set with 20 Seconds Hold. Thera-Band Exercises Includes Dorsiflexion, Plantar Flexion ,Inversion, Eversion With 10 Repetitions x 4 Sets. Strengthening Exercises Includes Double Leg Heel Raise Single Leg Heel Raise Standing Toe Raise With 10 Repetitions x 3 Sets. Maintain Proper Balance In a Double And Single Limb Stance. Standing Position In a Double And Single Limb Stance Combined With Throwing And Catching With 10 Repetitions x 3 Sets. Bosu Ball Exercises Includes Double Leg Balance, Single Leg Balance, Mini Squats With Hold Standing Balance Poses for 10 Sec - 1 Min Progressing When Stable. Single Leg Hopping Double Leg Hopping, Lateral Bounding, Plyometrics: Multidirectional Jumps Drills With 10 Repetitions x 3 Sets. 
Comparator Agent  Virtual training  Grade III-IV Mobilization To Talocrural, Subtalar And Midfoot for Pain Control and Mobility For 30 Seconds Of Manual Therapy, With 1 Min Rest With 3 Repetition. Utilize Lace Up Brace For Functional Activities As Needed. Gastrocnemius Stretch And Soleus Stretch With 10 Repetitions x 1 set With 20 Seconds Hold. Knee to Wall Closed Chain Dorsiflexion Mobilization With 10 Repetitions × 1 Set With 20 Seconds Hold. Thera-Band Exercises Includes Dorsiflexion, Plantar Flexion, Inversion, Eversion with 10 Repetitions x 4 Sets. Strengthening Exercises Includes Double Leg Heel Raise Single Leg Heel Raise Standing Toe Raise With 10 Repetitions x 3 Sets. Maintain Proper Balance In a Double And Single Limb Stance. Standing Position In a Double And Single Limb Stance Combined With Throwing And Catching With 10 Repetitions x 3 Sets. Bosu Ball Exercises Includes Double Leg Balance, Single Leg Balance, Mini Squats With Hold Standing Balance Poses for 10 Sec - 1 Min Progressing When Stable. Virtual Games Includes VZ Fit With Ring Racer, Clean Sheet in Thrice a Week For 10 minutes. Single Leg Hopping Double Leg Hopping, Lateral Bounding, Plyometrics: Multidirectional Jumps Drills With 10 Repetitions x 3 Sets. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Badminton players with clinically diagnosed ankle instability.
2. Age between 18 and 30 years.
3. Regular participation in badminton activities.  
 
ExclusionCriteria 
Details  History of significant lower limb injury, other conditions like fracture or surgeries other than
ankle instability.
Presence of neurological conditions affecting balance
Any medical or musculoskeletal condition that may interfere with the study outcomes.
Patients who not willing to take rehabilitaion 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Hop Test
Star excursion balance test (SEBT)
Cumberland ankle instability tool
 		 baseline data will be collected and data analysis will be assessed after 6 week 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   30/05/2024 
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 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 - NO
Brief Summary   The study aims to evaluate the effect of conventional therapy along with adjunct virtual reality training on dynamic balance, hop test and function in badminton players with ankle instability. 
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