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CTRI Number  CTRI/2025/08/093704 [Registered on: 26/08/2025] Trial Registered Prospectively
Last Modified On: 25/08/2025
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   Virtual-Reality vs Traditional Exercises for Ankle Strength, Balance and Exercise Motivation in people with Chronic Ankle Instability 
Scientific Title of Study   Effectiveness of Virtual-Reality versus Conventional Rehabilitation on Strength, Proprioception, Dynamic Balance, Function and Exercise Adherence in Individuals with Chronic Ankle Instability 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Adeeba Sayed 
Designation  PG Student 
Affiliation  D Y Patil Deemed to be University, School of Physiotherapy 
Address  D Y Patil Deemed to be University, School of Physiotherapy, Department of Musculoskeletal Sciences, 6th floor

Thane
MAHARASHTRA
400706
India 
Phone  9082555429  
Fax    
Email  adeebasayed1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shellette D Almeida 
Designation  Associate Professor 
Affiliation  D Y Patil Deemed to be University, School of Physiotherapy 
Address  D Y Patil Deemed to be University, School of Physiotherapy, Department of Musculoskeletal Sciences, 6th floor

Thane
MAHARASHTRA
400706
India 
Phone  9591234304  
Fax    
Email  shellette.almeida@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Adeeba Sayed 
Designation  PG Student 
Affiliation  D Y Patil Deemed to be University, School of Physiotherapy 
Address  D Y Patil Deemed to be University, School of Physiotherapy, Department of Musculoskeletal Sciences, 6th floor

Thane
MAHARASHTRA
400706
India 
Phone  9082555429  
Fax    
Email  adeebasayed1@gmail.com  
 
Source of Monetary or Material Support  
D Y Patil University, School of Physiotherapy, Navi Mumbai 
 
Primary Sponsor  
Name  School of Physiotherapy 
Address  D Y Patil University, School of Physiotherapy, 6th floor, Plot No 2, Sector 5, Nerul, Navi Mumbai 
Type of Sponsor  Private medical college 
 
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 Adeeba Sayed  D Y Patil Hospital  D Y Patil Hospital, Department of Physiotherapy, Room Number 29
Thane
MAHARASHTRA 		 9082555429

adeebasayed1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) For Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A- Evidence based exercises   Week 1 and 2- Gastrocnemius stretch, soleus stretch, crossover lunges, bilateral heel raises, single-leg balance on firm surface and then foam pad with eyes open, multidirectional YBT training Week 3- Gastrocnemius stretch, soleus stretch, crossover lunges, progress to supported single-leg heel raises, single-leg standing on hard surface and eyes closed, multidirectional YBT training Week 4- Gastrocnemius stretch, soleus stretch, crossover lunges, progress to unsupported single-leg heel raises, add plyometric program, single-leg standing on hard surface and eyes closed, multidirectional YBT training  
Comparator Agent  Group B- Evidence based exercises and Virtual-Reality based exercises  Week 1 – Aladdin’s First Flight: Carpet navigation for proprioception, bridge walk (wide and stable) for balance, bilateral calf raises for virtual jewel collection for strength. Week 2 – Jewels of the Arabs: Carpet navigation with mild unpredictability for proprioception, narrow bridge walk for balance, bilateral narrow-stance calf raises for strength. Week 3 – Twirls and Tilts: Carpet navigation with obstacles for proprioception, narrow swaying bridge walk for balance, single-leg calf raises on stable surface for strength. Week 4 – Master of the Magic Carpet: Fast carpet navigation with obstacles for proprioception, tandem walk on unstable narrow bridge for balance, single-leg calf raises on unstable surface for strength. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Both Males and Females, age group 18 to 40 years, individuals who have a history of at least one sprain within the last 12 months, with pain,
swelling and weightbearing activity limitation for at least 24 hours during the same, history of at least two episodes of giving away in the last 6 months, cumberland Ankle Instability Score of less than or equal to 24 
 
ExclusionCriteria 
Details  Individuals unwilling to participate in the study, individuals with any known vision problems, patients with any neurological disorders affecting the balance or gait, patients with severe cardiovascular, autoimmune, inflammatory or systemic illnesses, Patients with recent lower limb fractures or surgery of less than 6 months 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Ankle strength, dynamic balance, proprioception  pre intervention and post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
foot and ankle ability measure and exercise adherence  pre intervention and post intervention 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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   Phase 3 
Date of First Enrollment (India)   15/09/2025 
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 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   Participants with Chronic Ankle Instability meeting the inclusion criteria with an age range of 18 to 40 years, will be recruited for the study. Randomization will be carried out , After providing consent, participants will complete a standardized demographic questionnaire, self-reported functional ability using the Foot and Ankle Ability Measure (FAAM) and their self-reported ankle instability using the Cumberland Ankle Instability Tool (CAIT). Conventional Intervention will focus on addressing the patient’s neuromuscular deficits. Interventions will be chosen to improve strength, proprioception and dynamic balance. A combined treatment approach as recommended by the CPG consisting of therapeutic exercise will be implemented to help the patient return to his prior level of function. The experimental rehabilitation program will focus on enhancing strength, proprioception and balance, through a progressive virtual reality-based intervention. A structured, gamified approach will be implemented, gradually increasing task complexity to improve neuromuscular control. Combining therapeutic exercise with immersive challenges, the program aims to optimize dynamic stability and functional performance, facilitating a safe return to activity.  
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