&quot;Effect of Immersive Virtual Reality in Adjunct to Conventional Physiotherapy on Static Balance, Dynamic Balance and Vertical Jump in Futsal Players with Lateral Ankle Sprain: A Protocol for Randomized Control Trial&quot;

Bharat Rathi; Swapnil Ramteke

doi:10.12688/f1000research.151934.1

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Study Protocol

"Effect of Immersive Virtual Reality in Adjunct to Conventional Physiotherapy on Static Balance, Dynamic Balance and Vertical Jump in Futsal Players with Lateral Ankle Sprain: A Protocol for Randomized Control Trial"

[version 1; peer review: 2 approved with reservations]

Bharat Rathi ¹, Swapnil Ramteke¹

PUBLISHED 12 Jun 2024

Author details Author details

¹ Sports Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute Higher Education and Research (DU), Sawangi (Meghe), Wardha- 442001, Wardha, Maharashtra, 442001, India

Bharat Rathi
Roles: Conceptualization, Funding Acquisition, Resources, Writing – Original Draft Preparation, Writing – Review & Editing

Swapnil Ramteke
Roles: Conceptualization, Supervision, Validation, Writing – Original Draft Preparation

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background

As there is high expense of treatment and potential long-term consequences including chronic ankle instability (CAI), lateral ankle sprains (LAS) are common among athletes and represent a substantial healthcare burden. In terms of preventing more injuries and encouraging a full recovery, traditional treatments frequently fall short.

Methods

At the Department of Sports Physiotherapy, futsal athletes with grade I and grade II lateral ankle sprains will participate in a parallel-group, 1:1 allocation ratio trial. Individuals who fulfil the eligibility requirements will be randomized at random to either the experimental or control group. Conventional physiotherapy treatments will be administered to the control group, and IVR sessions utilizing certain games will be administered to the experimental group in addition to the same therapies. The Y Balance Tool is used to measure dynamic balance, the X Sens MVN system is used to measure vertical jump, and the Balance Error Scoring System (BESS) is used to assess static balance.

Result

This study aims to offer a new way to improving results for futsal players recovering from lateral ankle sprains by utilizing IVR technology in conjunction with traditional physiotherapy. The results could lead to the creation of more efficient sports-related injury rehabilitation programs, which would improve athlete performance and lessen the incidence of ankle sprains in athletic populations.

CTRI Registration Number: CTRI/2024/04/065627

Name of registry: CTRI (Clinical Trials Registry)

No. CTRI/2024/04/065627

Date: 12/04/2024

URL: https://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=102982&EncHid=78848.18761&modid=1&compid=19

Keywords

Ankle Sprain, Virtual Reality, Physiotherapy, Futsal, Athletes, Static Balance, Vertical jump, Dynamic Balance.

Corresponding author: Bharat Rathi

Competing interests: No competing interests were disclosed.

Grant information: Intramural grant is obtained from Datta Meghe Institute of Higher Education & Research on 04/03/2024, DMIHER(DU)R&D/2024/164
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2024 Rathi B and Ramteke S. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Rathi B and Ramteke S. "Effect of Immersive Virtual Reality in Adjunct to Conventional Physiotherapy on Static Balance, Dynamic Balance and Vertical Jump in Futsal Players with Lateral Ankle Sprain: A Protocol for Randomized Control Trial" [version 1; peer review: 2 approved with reservations]. F1000Research 2024, 13:625 (https://doi.org/10.12688/f1000research.151934.1) First published: 12 Jun 2024, 13:625 (https://doi.org/10.12688/f1000research.151934.1) Latest published: 12 Jun 2024, 13:625 (https://doi.org/10.12688/f1000research.151934.1)

Introduction

The sports injury which is commonest in athletes is lateral ankle sprain (LAS). It causes a significant healthcare burden due to its high treatment costs as well as their long-term residual complications. Chronic ankle instability (CAI) is a syndrome that affects up to 40% of LAS patients. The characteristics of CAI are history of one severe LAS, repeated recurring sprains, incidents of the ankle giving way, or self-reported deficiencies in ankle function for more than a year after the initial sprain.¹

Ankle joint moves in the sagittal plane and is a hinge joint made of synovium. The distal epiphyses of the tibia and fibula form the hinge, which articulates in a highly congruent joint with the talus. It has mortise-like interlocks. Ankle sprains account for the majority of foot and ankle damage. The majority of people recover fully from them, but some experience chronic instability that makes it difficult for them to engage in strenuous activity.²

Ankle sprains account for 70% or more of all reported ankle injuries in numerous sports, and ankle injuries itself make up 10% to 30% of all athletic injuries. Treatment for ankle sprains is frequently insufficient. Ankle sprains occur more frequently than 40% of the time, and repeated sprains might result in chronic ankle instability (CAI).³

An injury to the ankle joint’s lateral ligament complex is known as an ankle sprain. On the basis of severity of the injury, a grade is assigned. The ligament complex is partially ruptured with mild joint instability in grade II (one anterior talofibular ligament rupture, for example), slightly stretched in grade I without producing joint instability, and completely ruptured with joint instability in grade III. This classification has little practical ramifications because grade I injuries do not require particular treatment after diagnosis, and grade II and III injuries get the same therapy. The studies that were included in this analysis either did not specify which grades of injuries were included, or they included both grade II and III injuries.⁴

An athlete complains to have “rolled over” their outer ankle after spraining their lateral ankle ligament. The entire foot and ankle need to be examined to make sure there are no more injuries. Two clinical stability tests for ligamentous injury are the anterior drawer test for ATFL function and the inversion tilt test for both ATFL and CFL function. Radiographs can rule out treatable fractures when there are significant injuries or when there is no pain or sensitivity coming from the lateral ligaments. Stress radiography has no effect on the course of treatment.⁵

To improving athlete performance through movement recognition and technique correction, machine learning-based real-time prediction and feedback have the potential to evaluate injury promoting factors. This is especially important for athletes with impairments because it is possible to create customized monitoring systems that can foresee injuries unique to their condition. Additionally, it pushes the researchers to create more beneficial, accurate, and real-time data that is easy to use and provides coaches and athletes with actionable insights based on frameworks for context-specific evaluation and the capacity to recognize proper forms and common deviations of particular movements in accordance with established clinical consensus.⁶

Virtual reality (VR) is defined as the computer-generated simulation of a three-dimensional. The cost of the new VR electrical technology, which is substantially less than that of the fixed virtual reality systems already in use, allows for high resolution, high frame rate, and sophisticated head tracking. It also includes a portable headset with an integrated screen. With such technology, it is considerably easier and more economical to adjust the sensory environment and regulate the variability of the experience’s intensity (dosing) inside “eyes open” task. The emphasis on sensory integration is consistent with studies conducted in 2008 by Kleim and Jones, who emphasized the significance of treating sensory deficiencies. Furthermore, it’s remarkable that the platform can provide these advantages without tipping over healthy young adults on a level surface. It demonstrates a careful effort to guaranteeing the technology’s usability for various user groups.⁷

Ivan Sutherland initially invented the notion of virtual reality in 1960.Thirteen virtual reality systems provide a window of interaction between users and a computer environment that mimics the real world. VR systems can be classified as immersive or non-immersive based on how much the user interacts with the virtual world and how many senses are engaged. Due to its three components interaction, immersion, and imagination—VR has been increasingly popular in rehabilitation over the past ten years. These factors have the potential to significantly improve motor learning. VR has certain benefits over traditional therapy. It gives patients a safe, virtual environment with functional tasks, immediate feedback, and appropriate incentives to boost adherence. Additionally, it offers customized programs for each patient and encourages them to take on challenging tasks in a secure environment, thereby increasing their capabilities. Because VR only needs minimal supervision, it can be used as a home-based program with unlimited repetitions, relieving physical therapists’ workload stress.⁸

Futsal requires accurate movements, fast direction changes, and fast reactions. Proprioception of the knee is important, particularly following ankle injuries. Recovery from ankle sprains requires both static and dynamic balance. Maintaining stability, avoiding further injuries, and promoting joint healing are all part of static balance. Muscle strengthening and functional movement depend on dynamic balance. Virtual reality headsets like the Immersive Virtual Reality are imaginatively utilized in sports to facilitate quick transitions and teach skills through simulated games. Immersive Virtual Reality is used in conjunction with physiotherapy activities to gradually improve ankle performance following injury. The objectives of physical therapy for lateral ankle sprains include successful rehabilitation and a safe return to regular activity. Previous studies suggest that enhancing futsal players’ ankle performance with a conventional physiotherapy training that uses Immersive Virtual Reality. This calls for strength training, stability, plyometrics, and agility. With the help of this compelling technology, the use of cutting-edge technologies such as Immersive Virtual Reality into sports instruction being investigated. The objective of the research is to evaluate how well traditional physiotherapy and a technology-integrated method (Immersive Virtual Reality + Physiotherapy) improve athletes’ performance in the vertical jump, dynamic balance, and static balance following ankle injuries.

Aim of the study

To evaluate the effect of immersive virtual reality (IVR) as an adjunct to conventional physiotherapy on static balance, dynamic balance, and vertical jump performance in futsal players recovering from lateral ankle sprain.

Objectives of the study

Primary objective:

1. To evaluate the effect of Immersive Virtual Reality on static balance, dynamic balance and vertical jump in futsal players with lateral ankle sprain.
2. To evaluate the effect of conventional training program on static balance, dynamic balance and vertical jump in futsal players with lateral ankle sprain.
3. To compare the effect of immersive virtual reality in combination with conventional training program on static balance, dynamic balance and vertical jump in futsal players with lateral ankle sprain.

Secondary objectives:

1. Evaluation of subgroup analysis for finding the effect of intervention in males and females.

Protocol

This protocol has been registered with CTRI: CTRI/2024/04/065627.

Institutional Ethical Committee approval number: DMIHER (DU)/IEC/2024/182.

IEC approval date: 30/01/2024

Trial design

It is a Two-arm parallel, single-center, Equal allocation superiority, Randomized controlled trial. This study will be conducted after obtaining informed consent from participants. Participants will be recruited from the Department of Sports Physiotherapy at Ravi Nair College of Physiotherapy in Sawangi, Meghe, Wardha, Maharashtra. Eligible participants will undergo screening based on predefined criteria, and individuals meeting the inclusion criteria will be enrolled. Allocation for both groups will be carried out via simple random selection to ensure fairness. This will be facilitated by a computer-generated random number system, utilizing the Sequentially Numbered Opaque Sealed Envelope Method for sample allocation. This study will be supervised by a departmental committee consisting of a PG Guide, the Head of the Department, the Principal of Ravi Nair Physiotherapy College (RNPC), and a member of the Research Guidance Cell. Patients will receive regular treatment sessions to adhere to recommended treatments, and if necessary, they will be reminded of therapy sessions via counselling or telephone contact. Athletes (Futsal Players) with the Lateral Ankle Sprain will be identified from Acharya Vinoba Bhave Rural Hospital as well as the from the Sports Department, Ravi Nair Physiotherapy College. Permission will be obtained from treating Doctors and then patient fulfilling the inclusion criteria will be randomly divided into two equal groups – Group A Group B. The Intervention given to Group A will be as per Physiotherapy Guidelines for Lateral ankle sprain (2021). The Intervention given to Group B will be as per Physiotherapy Guidelines for Lateral ankle sprain (2021) and it will be with the Immersive Virtual Reality.

Eligibility criteria

Inclusion criteria

1) Patient should be willing to participate in the study.
2) Both male and female Futsal athletes.
3) A diagnosis of Lateral Ankle Sprain in accordance with the diagnostic criteria for Ankle Sprain. (Grade I and Grade II)

Exclusion criteria

1) Futsal players with grade III Ankle sprain.
2) Athletes with pre-existing knee and hip injuries and Plantar fasciitis.
3) Neurological conditions like Cerebellar Ataxia.
4) Non-Futsal Athletes with Lateral Ankle Sprain.
5) Previous history of Foot Drop.

Participants timeline

Both groups will be receiving intervention for three sessions per week for a duration of four weeks. Pre- and post-intervention assessments will be taken, The CONSORT Flow chart, outlining participant flow from enrolment to analysis, is detailed in Figure 1.

Figure 1. The CONSORT flow chart.

Interventions

Control Group A: Conventional Physiotherapy

For Grade I ankle sprains, treatment involves cryotherapy, kinesiology taping, neuromuscular and balance training, strengthening exercises, and intrinsic muscle strengthening, all performed three times a week. Grade II treatment includes cryotherapy, therapeutic exercises, stretching, neuromuscular and balance training, strengthening exercises and intrinsic muscle strengthening exercises, also done three times a week. Motivational interviewing addresses psychological factors between sessions. These interventions aim to reduce pain, improve range of motion, restore strength, enhance balance, and boost self-efficacy for a safe return to activity. As shown in Table 1: Conventional Treatment Protocol.

Table 1. Conventional Physiotherapy.

Grade of Ankle sprain	Physical Therapy Treatment⁹	Dosage	Frequency: For four weeks, the workout regimen was followed three times a week¹⁰
Grade I	Cryotherapy	20 minutes every 4 hourly	Everyday
	Kinesiology Taping¹¹		3 sessions a week
	Neuromuscular and balance training (As per patient’s pain limit and progression- Double leg standing with closed eyes and perturbations progress to single leg standing with open and closed eyes with reach outs)	10 repetitions x 2 sets¹²	3 times a week
	Strengthening Exercises: Using weights and resistance bands, progress dorsiflexion, plantarflexion, eversion, and inversion from active range of motion exercises to resistive workouts (concentric and eccentric).	10 repetitions x 2 sets each	3 times a week
	Intrinsic muscles strengthening	10 repetitions x 2 sets each	3 times a week
Grade II	Cryotherapy	20 minutes every 4 hourly
	Therapeutic exercise including ROM exercises (Ankle plantarflexion, Ankle dorsiflexion, Knee Flexion, Knee extension)	10 repetitions x 2 sets each	3 times a week
	Stretching exercise (TA stretching)	30 sec x 3 sets¹³	3 times a week
	Neuromuscular and balance training (As per patient’s pain limit and progression- Double leg standing with closed eyes and perturbations progress to single leg standing with open and closed eyes with reach outs)	10 repetitions x 2 sets¹²	3 times a week
	Strengthening Exercises: Using weights and resistance bands, progress dorsiflexion, plantarflexion, eversion, and inversion from active range of motion exercises to resistive workouts (concentric and eccentric).	10 repetitions x 2 sets	3 times a week
	Intrinsic muscles strengthening	10 repetitions x 2 sets	3 times a week
Intervention to address psychological factors	Motivational interviewing (to maximize patients’ self-efficacy)	In between Physiotherapy session

Experimental Group B: Immersive Virtual Reality in adjunct to Conventional Physiotherapy

The experimental group’s treatment protocol for Grade I and Grade II ankle sprains involves incorporating immersive virtual reality (VR) games alongside conventional physical therapy exercises. For Grade I sprains, Cryotherapy and Kinesiology Taping are combined with neuromuscular and balance training using the Clean Sheet game, and strengthening exercises are performed using the 2MD: VR Football game. For Grade II sprains, the same Cryotherapy and Kinesiology Taping protocols are followed, along with therapeutic exercises and stretching. Neuromuscular and balance training are integrated into the Clean Sheet game, while strengthening exercises are conducted using the 2MD: VR Football game. Motivational interviewing addresses psychological factors between sessions to enhance self-efficacy. As shown in Table 2: Immersive Virtual Reality in adjunct to Conventional Physiotherapy.

Table 2. Experimental Group: Immersive Virtual Reality in adjunct to Conventional Physiotherapy.

The Experimental Group will receive the following treatment protocol along with the help of following games in Immersive Virtual Reality.

1) Clean Sheet
2) 2MD: VR Football

Grade of ankle sprain	Physical Therapy Treatment⁹	Dosage	Frequency: For four weeks, the workout regimen was followed three times a week¹⁰
Grade I	Cryotherapy	20 minutes every 4 hourly	Everyday
	Kinesiology Taping¹¹		3 sessions a week
	Neuromuscular and balance training in Clean Sheet game. (As per patient’s pain limit and progression- Double leg standing with perturbations progress to single leg standing)	10 repetitions x 2 sets	3 times a week
	Strengthening Exercises with 2MD: VR Football game: Using weights and resistance bands, progress dorsiflexion, plantarflexion, eversion, and inversion from active range of motion exercises to resistive workouts (concentric and eccentric).	10 repetitions x 2 sets each	3 times a week
	Intrinsic muscles strengthening	10 repetitions x 2 sets each	3 times a week
Grade II	Cryotherapy	20 minutes every 4 hourly	Everyday
	Therapeutic exercises including ROM (Ankle plantarflexion, Ankle dorsiflexion, Knee Flexion, Knee extension)	10 repetitions x 1 set each	3 times a week
	Stretching exercise (TA stretching)	30 sec x 3 sets¹³	3 times a week
	Neuromuscular and balance training in Clean Sheet game (As per patient’s pain limit and progression- Double leg standing with perturbations progress to single leg standing).	10 repetitions x 2 sets	3 times a week
	Strengthening Exercises in 2MD: VR Football game: Using weights and resistance bands, progress dorsiflexion, plantarflexion, eversion, and inversion from active range of motion exercises to resistive workouts (concentric and eccentric).	10 repetitions x 2 sets	3 times a week
	Intrinsic muscles strengthening	10 repetitions x 2 sets	3 times a week
Intervention to address psychological factors	Motivational interviewing (to maximize patients’ self-efficacy)	In between Physiotherapy session

Outcomes

Primary outcome

1. Static Balance:
Balance error scoring system (Static Balance) - A clinical assessment instrument called the Balance Error Scoring System (BESS) is used to measure balance and identify mild postural stability problems. It entails watching and rating particular mistakes made by an individual while they carry out different standing activities.
2. Dynamic Balance:
Y Balance Tool - The Y balancing Test (YBT), which focuses on balancing ability, uses three directional motions (AT, PM, and PL) to assess lower limb muscle strength, flexibility, and proprioception. With one leg supporting the body and the other extended, the distance in centi-meters is measured from the midfoot to the tip of the extended leg. If the supporting foot lifts off the ground, if balance is dependent on the extended foot, or if the foot does not return to its starting position, the subject is considered to have failed. To account for any differences in limb length, measurements are taken from the anterior superior iliac spine (ASIS) to the medial malleolus.¹⁴
3. Vertical Jump Test
X Sens (Vertical Jump Test) - The X Sens MVN system typically consists of wearable motion capture suits featuring inertial sensors. The suit is equipped with inertial sensors, like gyroscopes and accelerometers, to record the movements of different body parts.

Sample size

Minimum sample size required.

Sample size by Cohen’s effect size by comparing two means.

Effect size = d = \frac{μ_{2} - μ_{1}}{σ} = 0.8 (Estimated) for Y Balance Test .

Considering large effect size difference = 0.8 (Large effect size)

Sample size N = (\frac{1 + r}{r}) \frac{{(Z_{1 - \frac{α}{2}} + Z_{1 - β})}^{2}}{d^{2}} + \frac{Z_{1 - α / 2}^{2}}{2 (1 + r)}

$Z_{1 - \frac{α}{2}}$ at 5% level of significance = 1.96

$Z_{1 - β}$ at 80% Power = 0.84

Ratio allocation (Group2/Group1) = 1

Sample size n = (\frac{1 + 1}{1}) \frac{{(1.96 + 0.84)}^{2}}{{0.8}^{2}} + \frac{{(1.96)}^{2}}{2 (1 + 1)} = 26 per group .

Considering 15% drop out total = 4

A total of 30 samples are required per group.

Safety outcomes

Adverse events if any, will be documented during each session.

Methods

Data collection methods: Participants meeting the inclusion criteria will be enrolled in the study. Baseline data will be collected before the intervention begins. Post-intervention data will be collected after the completion of the four-week intervention period.

Analysis

The full analysis data set will include all the study participants with no missing values for all the parameters in the data set. The study subjects will be the participants fulfilling inclusion and exclusion criteria

Outcome variables: Primary outcomes

1. Balance error scoring system (BESS)
2. Y Balance test
3. X Sens

Secondary variables:

1. Gender

All the data will be summarized with Baseline characteristics for demographic variables will be described by frequency and percentage for categorical data and with mean and standard deviation for continuous data.

Outcome variables will be analysed over continuous variables will be summarised with the minimum, maximum, mean, standard deviation, standard error and CI at 95% for parametric data. Data over the continuous outcome variables will be firstly tested using normality test using Kolmogorov-Smirnov test at 5% level of significance (P≤0.05). If rejected data will be considered as normal otherwise non parametric test will be used for finding significance. T- test will be used to find the significance difference at 5% level (P≤0.05) for comparative groups.

1) Immersive Virtual Reality in adjunct to Conventional Physiotherapy
2) Conventional Physiotherapy

Non normal data will be described by mean, median, lower and upper quartiles for using nonparametric test. And will be used for testing significance using Mann-Whitney test.

Categorical variables will be summarised by frequency (N) and percentages value (%). Efficacy over the categorial variable will be analysed by chi square analysis for finding efficacy.

Methods: monitoring

DATA MONITORING: The data will be monitored by the Data Monitoring Committee of Ravi Nair Physiotherapy College.

Harms

Any episode of the adverse events shall be reported to the Ethical Committee and the clinician in charge for assessing and managing the solicited and spontaneous adverse events and other unintended effects of trial interventions or trial conduct.

Ethics and dissemination

Consent and assent:

Participants enrolled in the study will be fully informed about the study, and their written informed consent and assent will be obtained from each individual.

Confidentiality: All information related to the study participants will be kept confidential. Patient-related data will only be utilized with explicit permission from the subjects.

Declaration of interests: There are no financial or competing interests to mention.

Access to data: The Principal Investigator (PI) will oversee the storage and maintenance of all data gathered throughout or after the study. The PI will retain access to the ultimate trial dataset, which will be shared in a de-identified format upon formal request, specifically for research and publication purposes only.

Ancillary and post-trial care: In the event of any occurrences resulting in harm from trial participation, care will be provided to the study subjects by the Principal Investigator (PI) following the policies outlined by Ravi Nair Physiotherapy College and DMIHER.

Dissemination policy: Data collected during or after the study will only be utilized for academic and research-related purposes culminating in a publication in a reputed journal.

Study status

The Recruitment of participants has not yet started.

Discussion

Lateral ankle sprain (LAS) is a common sports injury that frequently impacts physical performances of individuals involved in game like futsal where agility activities like accurate movements, fast direction changes, and fast reactions is required. While conventional physiotherapy approaches have been widely utilized in the Intervention of LAS, there is still a demand for innovative interventions to address this condition to optimize treatment outcomes, to reduced recurrence rates, and enhance patient satisfaction. Our study protocol introduces the integration of immersive virtual reality as an adjunct to conventional physiotherapy, aiming to address the multifaceted nature of LAS by targeting both physical symptoms and psychological factors in futsal athletes.

When compared to traditional or no intervention, the meta-analysis of four clinical trials’ results demonstrated a strong and consistent impact of virtual reality (VR) on static balance. However, the research supporting the efficacy of VR apps for dynamic balancing is not entirely conclusive.¹⁵

The results demonstrate that impairments in proprioception, namely in the unconscious (reflexive) as opposed to the conscious (voluntary) component of proprioception, result in balance problems after Grade I and II lateral ankle sprains. This component probably has a major role in the recurrence of ankle sprains. Therefore, maintaining an effective rehabilitation program is crucial for managing proprioceptive deficits.¹⁶

Studies have demonstrated the beneficial effects of incorporating virtual reality into rehabilitation programs on motor learning and functional recovery, especially when it comes to activities involving balance and coordination.¹⁷

This study offers some support for the use of Virtual reality assisted intervention in functional ankle instability rehabilitation but no insight into the clinical question of whether the Virtual reality (VR) approach may be used in place of standard physiotherapy procedures or vice versa. On the other hand, we would advise using the VR technique to supplement conventional physiotherapy techniques.¹⁰

Physiotherapists believe that Oculus Quest 2 can be a helpful virtual reality system for shoulder musculoskeletal therapy because it is user-friendly and entertaining for patients. To boost the likelihood that patients will use the system on their own, a few changes are necessary. Virtual reality (VR) can be used in orthopaedic rehabilitation, and the research supporting its effectiveness is generally positive.¹⁸

The purpose of our study is to determine whether using Immersive Virtual Reality (IVR) in adjunct with conventional physiotherapy can improve the performance of futsal players with lateral ankle sprains (LAS) in terms of static balance, dynamic balance, and vertical jump. This study will examine the possible effects of these interventions on sports rehabilitation and emphasize the value of using cutting-edge technology like IVR, by employing rigorous methodology, including randomization and outcome measures such as the Balance Error Scoring System (BESS) (static balance), Y Balance tool (dynamic balance) and X Sens (vertical jump performance). By using IVR for ankle rehabilitation process will probably lead to an early recovery and better prognosis in futsal athletes with LAS.

Ethical considerations

Ethical approval was received from the Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe), Wardha on January 30^th 2024 Institutional Ethical Committee approval number: DMIHER (DU)/IEC/2024/182.

Participants enrolled in the study will be fully informed about the study, and their written informed consent and assent will be obtained from each individual.

Data availability

Underlying data

No data were associated with this article.

Extended data

Repository Name: Figshare

File Name: SPIRIT Checklist for “Effect of Immersive Virtual Reality in Adjunct to Conventional Physiotherapy on Static Balance, Dynamic Balance and Vertical Jump in Futsal Players with Lateral Ankle Sprain: A Protocol for Randomized Control Trial”.

DOI: 10.6084/m9.figshare.25826125.v1.¹⁹

URL: https://doi.org/10.6084/m9.figshare.25826125.v1.

License: CC BY 4.0

Acknowledgments

The authors express their gratitude to DMIHER, for there assistance in sample size calculation and data analysis.

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Author details Author details

¹ Sports Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute Higher Education and Research (DU), Sawangi (Meghe), Wardha- 442001, Wardha, Maharashtra, 442001, India

Bharat Rathi
Roles: Conceptualization, Funding Acquisition, Resources, Writing – Original Draft Preparation, Writing – Review & Editing

Swapnil Ramteke
Roles: Conceptualization, Supervision, Validation, Writing – Original Draft Preparation

Competing interests

No competing interests were disclosed.

Grant information

Intramural grant is obtained from Datta Meghe Institute of Higher Education & Research on 04/03/2024, DMIHER(DU)R&D/2024/164
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Published: 12 Jun 2024, 13:625

https://doi.org/10.12688/f1000research.151934.1

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© 2024 Rathi B and Ramteke S. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Rathi B and Ramteke S. "Effect of Immersive Virtual Reality in Adjunct to Conventional Physiotherapy on Static Balance, Dynamic Balance and Vertical Jump in Futsal Players with Lateral Ankle Sprain: A Protocol for Randomized Control Trial" [version 1; peer review: 2 approved with reservations]. F1000Research 2024, 13:625 (https://doi.org/10.12688/f1000research.151934.1)

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PUBLISHED 12 Jun 2024

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Reviewer Report 12 Jul 2024

Aude Aguilaniu, University of Liège, Liège, Belgium

Approved with Reservations

https://doi.org/10.5256/f1000research.166628.r299357

Dear author,
Thank you for this interesting work entitled : « Effect of Immersive Virtual Reality in Adjunct to Conventional Physiotherapy on Static Balance, Dynamic Balance and Vertical Jump in Futsal Players with Lateral Ankle Sprain: A Protocol for Randomized Control ... Continue reading

Dear author,
Thank you for this interesting work entitled : « Effect of Immersive Virtual Reality in Adjunct to Conventional Physiotherapy on Static Balance, Dynamic Balance and Vertical Jump in Futsal Players with Lateral Ankle Sprain: A Protocol for Randomized Control Trial ».

Authors describe a protocol to evaluate the effect of Immersive Virtual Reality on static balance, dynamic balance and vertical jump in after a lateral ankle sprain in Futsal athletes. A control group will receive a conventional physiotherapy and an intervention group will receive immersive virtual reality in adjunct to conventional physiotherapy.

Here is some comments and questions to help to improve the paper.

Introduction :
Few citations are available in the introduction whereas a lot of information is given. I suggest associating more citation on what is said.

Methodology
- When the participant will be recruited? How many days/weeks after the injury? I suggest defining in the inclusion/exclusion criteria a timeline because rehabilitation in acute or subacute phase will be different. Then, I was also wondering when the baseline data will be recorded because in acute phase the athlete could probably not jump?
- Do you plan to also include athletes who had a previous injury or only athletes who present an ankle sprain for a first time?
Why do you include stretching for grade III and not for grade II ?
- Concerning the dosage, I suggest increasing the global charge during the rehabilitation and explain how you will do it. How will you set the weight resistance and the time it will take at the first session and at the last session? Will it be the same weight for all or the weight will be set according to which parameters? Could you make an estimation of the time it will take for a session (is it longer or shorter with the VR ?, Is the global volume will be similar because it could impact the results)
- In the table 2, it is specified that VR is used to strengthening part so it would be appropriate to add dorsiflexor, plantarflexor, evertor and invertor strength assessment in the outcome. I also suggest adding range of motion with the WBLT as an outcome (because a deficit in dorsiflexion is a risk factor to sustain an ankle sprain).

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: physiotherapy, ankle sprain

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

CITE

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13

Reviewer Report 05 Jul 2024

Jente Wagemans, University of Antwerp, Antwerp, Belgium

Approved with Reservations

https://doi.org/10.5256/f1000research.166628.r299355

Dear author,
Thank you for publishing your methods. With upcoming research regarding motor learning and brain involvement in ligament injuries, this type of interventions can make a real difference. I do have some concerns regarding the paper itself and ... Continue reading

Dear author,
Thank you for publishing your methods. With upcoming research regarding motor learning and brain involvement in ligament injuries, this type of interventions can make a real difference. I do have some concerns regarding the paper itself and the methods. I hope my feedback is constructive and useful:
A Introduction:
1. May I suggest to use more references throughout the entire work: many statements are made without a reference.
2. Paragraph 1, sentence 2: Could you provide exact numbers regarding the socio-economic impact of lateral ankle sprains?
3. Paragraph 1: CAI is mentioned as a "syndrome" - may I suggest consulting the current state of the art regarding this semantics.
4. Paragraph 1: the characteristics of CAI: you mention history of a "severe" LAS - again, may I suggest consulting current literature.
5. Paragraph 2: "ankle joint moves in the sagittal plane" - the ankle movements are triplanar.
6. Paragraph 4: "grade I injuries do not require particular treatment after diagnosis" - please consult most recent literature. The majority of LAS are Grade I, and are considered innocuous; yet 40% develop CAI, and in some sports up to 47% have recurrent LAS.

B. Methodology:
The methods are very clear. I have one concern in terms of sample size. The calculation itself is correct. What is the basis for the considered effect size of 0.8? Please look at previously published RTC's or meta-analyses regarding exercise-based interventions for true found effects of interventions on balance tests or jump tests, and redo the sample size calculations. Arbitrarily considering a large effect can fuel power failure and statistical error.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Sports medical & Rehabilitation sciences, physiotherapy

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

CITE

Report a concern

Respond or Comment

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Jente Wagemans, University of Antwerp, Antwerp, Belgium
Aude Aguilaniu, University of Liège, Liège, Belgium

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Reviewer Report

10 Views

12 Jul 2024 | for Version 1

Aude Aguilaniu, University of Liège, Liège, Belgium

10 Views Cite this report Responses(0)

Approved With Reservations

Dear author,
Thank you for this interesting work entitled : « Effect of Immersive Virtual Reality in Adjunct to Conventional Physiotherapy on Static Balance, Dynamic Balance and Vertical Jump in Futsal Players with Lateral Ankle Sprain: A Protocol for Randomized Control Trial ».

Authors describe a protocol to evaluate the effect of Immersive Virtual Reality on static balance, dynamic balance and vertical jump in after a lateral ankle sprain in Futsal athletes. A control group will receive a conventional physiotherapy and an intervention group will receive immersive virtual reality in adjunct to conventional physiotherapy.

Here is some comments and questions to help to improve the paper.

Introduction :
Few citations are available in the introduction whereas a lot of information is given. I suggest associating more citation on what is said.

Methodology
- When the participant will be recruited? How many days/weeks after the injury? I suggest defining in the inclusion/exclusion criteria a timeline because rehabilitation in acute or subacute phase will be different. Then, I was also wondering when the baseline data will be recorded because in acute phase the athlete could probably not jump?
- Do you plan to also include athletes who had a previous injury or only athletes who present an ankle sprain for a first time?
Why do you include stretching for grade III and not for grade II ?
- Concerning the dosage, I suggest increasing the global charge during the rehabilitation and explain how you will do it. How will you set the weight resistance and the time it will take at the first session and at the last session? Will it be the same weight for all or the weight will be set according to which parameters? Could you make an estimation of the time it will take for a session (is it longer or shorter with the VR ?, Is the global volume will be similar because it could impact the results)
- In the table 2, it is specified that VR is used to strengthening part so it would be appropriate to add dorsiflexor, plantarflexor, evertor and invertor strength assessment in the outcome. I also suggest adding range of motion with the WBLT as an outcome (because a deficit in dorsiflexion is a risk factor to sustain an ankle sprain).

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

physiotherapy, ankle sprain

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Respond to this report

Responses (0)

Back to all reports

Reviewer Report

13 Views

05 Jul 2024 | for Version 1

Jente Wagemans, University of Antwerp, Antwerp, Belgium

13 Views Cite this report Responses(0)

Approved With Reservations

Dear author,
Thank you for publishing your methods. With upcoming research regarding motor learning and brain involvement in ligament injuries, this type of interventions can make a real difference. I do have some concerns regarding the paper itself and the methods. I hope my feedback is constructive and useful:
A Introduction:
1. May I suggest to use more references throughout the entire work: many statements are made without a reference.
2. Paragraph 1, sentence 2: Could you provide exact numbers regarding the socio-economic impact of lateral ankle sprains?
3. Paragraph 1: CAI is mentioned as a "syndrome" - may I suggest consulting the current state of the art regarding this semantics.
4. Paragraph 1: the characteristics of CAI: you mention history of a "severe" LAS - again, may I suggest consulting current literature.
5. Paragraph 2: "ankle joint moves in the sagittal plane" - the ankle movements are triplanar.
6. Paragraph 4: "grade I injuries do not require particular treatment after diagnosis" - please consult most recent literature. The majority of LAS are Grade I, and are considered innocuous; yet 40% develop CAI, and in some sports up to 47% have recurrent LAS.

B. Methodology:
The methods are very clear. I have one concern in terms of sample size. The calculation itself is correct. What is the basis for the considered effect size of 0.8? Please look at previously published RTC's or meta-analyses regarding exercise-based interventions for true found effects of interventions on balance tests or jump tests, and redo the sample size calculations. Arbitrarily considering a large effect can fuel power failure and statistical error.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Sports medical & Rehabilitation sciences, physiotherapy

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Respond to this report

Responses (0)

[1] 1. Dhillon MS, Patel S, Baburaj V: Ankle Sprain and Chronic Lateral Ankle Instability: Optimizing Conservative Treatment. Foot Ankle Clin. 2023 Jun; 28(2): 297–307. Publisher Full Text

[2] 2. Marín Fermín T, Al-Dolaymi AA, D’Hooghe P: Acute Ankle Sprain in Elite Athletes: How to Get Them Back to the Game? Foot Ankle Clin. 2023 Jun 1; 28(2): 309–320. Publisher Full Text

[3] 3. Kobayashi T, Tanaka M, Shida M: Intrinsic Risk Factors of Lateral Ankle Sprain. Sports Health. 2016 Mar; 8(2): 190–193. PubMed Abstract | Publisher Full Text | Free Full Text

[4] 4. Struijs PA, Kerkhoffs GM: Ankle sprain. BMJ. Clin. Evid. 2010 May 13; 2010: 1115.

[5] 5. Lynch SA, Renström PAFH: Treatment of Acute Lateral Ankle Ligament Rupture in the Athlete. Sports Med. 1999 Jan 1; 27(1): 61–71. Publisher Full Text

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[7] 7. Feasibility and reliability of a virtual reality oculus platform to measure sensory integration for postural control in young adults: Physiotherapy Theory and Practice.[cited 2024 Jan 10]; 34(12): 935–950. PubMed Abstract | Publisher Full Text

[8] 8. Hoch MC, McKeon PO: Peroneal reaction time after ankle sprain: a systematic review and meta-analysis. Med. Sci. Sports Exerc. 2014 Mar; 46(3): 546–556. PubMed Abstract | Publisher Full Text

[9] 9. Martin RL, Davenport TE, Fraser JJ, et al.: Ankle Stability and Movement Coordination Impairments: Lateral Ankle Ligament Sprains Revision 2021: Clinical Practice Guidelines Linked to the International Classification of Functioning, Disability and Health From the Academy of Orthopaedic Physical Therapy of the American Physical Therapy Association. J. Orthop. Sports Phys. Ther. 2021 Apr; 51(4): CPG1–CPG80. PubMed Abstract | Publisher Full Text

[10] 10. Kim K, Choi B, Lim W: The efficacy of virtual reality assisted versus traditional rehabilitation intervention on individuals with functional ankle instability: a pilot randomized controlled trial. Disabil. Rehabil. Assist. Technol. 2019 Apr 3; 14(3): 276–280. PubMed Abstract | Publisher Full Text

[11] 11. Wang Y, Gu Y, Chen J, et al.: Kinesio taping is superior to other taping methods in ankle functional performance improvement: a systematic review and meta-analysis. Clin. Rehabil. 2018 Nov 1; 32(11): 1472–1481. PubMed Abstract | Publisher Full Text

[12] 12. Coughlan G, Caulfield B: A 4-Week Neuromuscular Training Program and Gait Patterns at the Ankle Joint. J. Athl. Train. 2007; 42(1): 51–59. PubMed Abstract

[13] 13. Terada M, Pietrosimone BG, Gribble PA: Therapeutic Interventions for Increasing Ankle Dorsiflexion After Ankle Sprain: A Systematic Review. J. Athl. Train. 2013 Oct 1; 48(5): 696–709. PubMed Abstract | Publisher Full Text | Free Full Text

[14] 14. Lee SK, Ahn SH: Effects of balance evaluation comparison of dynamic balance and Y balance. J. Exerc. Rehabil. 2018 Dec 27; 14(6): 939–943. PubMed Abstract | Publisher Full Text | Free Full Text

[15] 15. Elaraby AER, Shahien M, Jahan AM, et al.: The Efficacy of Virtual Reality Training in the Rehabilitation of Orthopedic Ankle Injuries: A Systematic Review and Meta-analysis. Adv. Rehabil. Sci. Pract. 2023; 12: 117957272311516. Publisher Full Text

[16] 16. Akbari M, Karimi H, Farahini H, et al.: Balance problems after unilateral lateral ankle sprains. J. Rehabil. Res. Dev. 2006; 43(7): 819–824. PubMed Abstract | Publisher Full Text

[17] 17. Saposnik G, Mamdani M, Bayley M, et al.: Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST): rationale, design, and protocol of a pilot randomized clinical trial assessing the Wii gaming system. Int. J. Stroke. 2010 Feb; 5(1): 47–51. PubMed Abstract | Publisher Full Text | Free Full Text

[18] 18. Longo UG, Carnevale A, Andreoli F, et al.: Immersive virtual reality for shoulder rehabilitation: evaluation of a physical therapy program executed with oculus quest 2. BMC Musculoskelet. Disord. 2023 Nov 2; 24(1): 859. PubMed Abstract | Publisher Full Text | Free Full Text

[19] 19. Rath B: SPIRIT Checklist for “Effect of Immersive Virtual Reality in Adjunct to Conventional Physiotherapy on Static Balance, Dynamic Balance and Vertical Jump in Futsal Players with Lateral Ankle Sprain: A Protocol for Randomized Control Trial”. figshare. 2024. Publisher Full Text

"Effect of Immersive Virtual Reality in Adjunct to Conventional Physiotherapy on Static Balance, Dynamic Balance and Vertical Jump in Futsal Players with Lateral Ankle Sprain: A Protocol for Randomized Control Trial"

Abstract

Background

Methods

Result

Keywords

Introduction

Aim of the study

Objectives of the study

Protocol

Trial design

Eligibility criteria

Participants timeline

Figure 1. The CONSORT flow chart.

Interventions

Table 1. Conventional Physiotherapy.

Table 2. Experimental Group: Immersive Virtual Reality in adjunct to Conventional Physiotherapy.

Outcomes

Sample size

Safety outcomes

Methods

Analysis

Methods: monitoring

Harms

Ethics and dissemination

Study status

Discussion

Ethical considerations

Data availability

Underlying data

Extended data

Acknowledgments

References

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