CTRI

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CTRI Number

CTRI/2025/04/083864 [Registered on: 02/04/2025] Trial Registered Prospectively

Last Modified On:

28/03/2025

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

Effect of Immersive Virtual Reality-Based Rehabilitation on Functional and Balance Recovery in Individuals following Lateral Ankle Sprain

Scientific Title of Study

Immersive Virtual Reality based Rehabilitation In Improving Functional and Balance Deficits Following Lateral Ankle Sprain

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Aina Fatima
Designation	PG Scholar
Affiliation	Jamia Hamdard University
Address	Room number 501 Sports Exercise Science and Research Lab Department Of Physiotherapy 5th floor Central Library Building Jamia Hamdard University G782 55X Mehrauli Badarpur Rd near Batra Hospital Block D Hamdard Nagar New Delhi New Delhi DELHI 110062 India
Phone	6386339722
Fax
Email	ainaafatimaa@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Deepak Malhotra
Designation	Assistant Professor
Affiliation	Jamia Hamdard University
Address	Room number 501 Sports Exercise Science and Research Lab Department of Physiotherapy 5th floor Central Library Building Jamia Hamdard University G782 55X MEHRAULI BADARPUR RD NEAR BATRA HOSPITAL BLOCK D HAMDARD NAGAR NEW DELHI New Delhi DELHI 110062 India
Phone	6386339722
Fax
Email	dmalhotra@jamiahamdard.ac.in

Details of Contact Person
Public Query

Name	Aina Fatima
Designation	PG Scholar
Affiliation	Jamia Hamdard University
Address	Room number 501 Sports Exercise Science and Research Lab Department Of Physiotherapy 5th floor Central Library Building Jamia Hamdard University G782 55X Mehrauli Badarpur Rd near Batra Hospital Block D Hamdard Nagar New Delhi New Delhi DELHI 110062 India
Phone	6386339722
Fax
Email	ainaafatimaa@gmail.com

Source of Monetary or Material Support

Department Of Physiotherapy 5th floor Central Library Building Jamia Hamdard University G782 55X Mehrauli Badarpur Rd near Batra Hospital Block D Hamdard Nagar New Delhi 110062

Primary Sponsor

Name	Dr Deepak Malhotra Assistant Professor
Address	Department of Physiotherapy, 5th Floor, Central Library Building, Jamia Hamdard University, New Delhi, 110062
Type of Sponsor	Other [Deemed To be University]

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 Aina Fatima	Sports Exercise Science and Research Lab	Department Of Physiotherapy, 5th Floor, Central Library Building, Jamia Hamdard University New Delhi DELHI	6386339722 ainaafatimaa@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Jamia Hamdard Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: S934\|\|Sprain of ankle,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Immersive Virtual Reality and Traditional Rehabilitation in Group A.	6 weeks protocol, 2 sessions per week, total number of sessions- 12 . Group A (Intervention Group) Immersive VR-based Rehabilitation with + Traditional Rehabilitation Training frequency 2 sessions per week VR-based balance and proprioception training using an Head mounted device Meta Quest 2 model. Traditional physiotherapy for ankle strength, balance, and proprioception using Thera bands and stability trainers.
Comparator Agent	Traditional Rehabilitation Group B	6 weeks protocol, 2 sessions per week, total number of sessions- 12 Traditional physiotherapy for ankle strength, balance, and proprioception using Thera bands and stability trainers.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	50.00 Year(s)
Gender	Both
Details	Males and females aged 18 to 50 years Individuals with a history of lateral ankle sprain Foot & Ankle Disability Index (FADI) score difference of 8 to 10 percentage out of 100 percentage

ExclusionCriteria

Details

Acute Ankle Sprain [24HRS TO ONE WEEK]
Pregnancy
Color blindness (self-reported)
Motion sickness (self-reported)
History of balance or neurological disorders
History of osteopenia or osteoporosis

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Dates of Birth or day of the Week

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
Foot & Ankle Disability Index (FADI)	Baseline and Post Intervention

Secondary Outcome

Outcome	TimePoints
Modified Y Balance Test	Baseline and Post Intervention

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

Phase 1

Date of First Enrollment (India)

28/04/2025

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="25"
Months="5"
Days="20"

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

Background & Rationale

The ankle-foot complex plays a critical role in human movement, and its stability is essential for activities like walking, running, and jumping. Lateral ankle sprains (LAS) are among the most common musculoskeletal injuries, affecting both the general population and athletes (Munn et al., 2010). Improper healing or recurrent sprains can lead to chronic ankle instability (CAI), which impairs proprioception and balance (Griffith & Brockwell, 2006).

Virtual Reality (VR) rehabilitation offers an interactive platform that enhances proprioception, joint function, and balance control through immersive, sensorimotor feedback mechanisms (Schultheis & Rizzo, 2001; Vernadakis et al., 2014). While previous research has focused on semi-immersive VR, this study will examine the effects of immersive VR-based rehabilitation using a head-mounted display (HMD) in individuals with lateral ankle sprains.

Research Question

What are the effects of immersive virtual reality-based rehabilitation interventions on improving functional and balance deficits among individuals following a lateral ankle sprain?

Hypothesis

Experimental Hypothesis

Subjects who undergo immersive VR-based rehabilitation following a lateral ankle sprain will show significant improvements in function and balance compared to those receiving traditional rehabilitation alone.

Null Hypothesis

There will be no significant difference in the effectiveness of immersive VR-based rehabilitation in improving functional and balance deficits following a lateral ankle sprain.

Study Objectives

To evaluate the effectiveness of immersive VR-based rehabilitation in improving balance and functional deficits following a lateral ankle sprain.

Expected Outcomes & Clinical Significance

VR-based rehabilitation is expected to enhance proprioception, balance, and functional recovery in individuals with lateral ankle sprains. The immersive environment may improve motivation, adherence, and engagement in rehabilitation (Burdea, 2003). This study may support the integration of immersive VR into physiotherapy protocols for ankle rehabilitation.