Effects of Immersive Virtual Reality on Balance, Mobility, and Fatigue in Patients With Multiple Sclerosis

Study Overview
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Brief Summary
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Gait disorder, imbalance, and fatigue are the most frequently reported complaints in Multiple Sclerosis (MS), a chronic neurodegenerative disease. The first symptoms in patients with MS are emerging in the age range 20-50 and these patients need long-term rehabilitation. The virtual reality applications developed for these problems which affect the quality of life negatively and cause disability in the following periods may be a good alternative for conventional rehabilitation applications. In this long-term where motivation is important, virtual reality applications in different environments provide patients with the opportunity to do many different tasks amused. In recent years, the vividness has been increased by the 3D virtual reality headsets. The aim of this study is to investigate the effects of immersive virtual reality on the balance, mobility, and fatigue in patients with MS.

Detailed Description
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The study was designed as a prospective, randomized controlled study. The patients will be randomly assigned to three groups, the immersive virtual reality (IVR) group, the dynamic balance training (DBT) group and the control group. The trainings will be twice a week for 8 weeks. In the IVR group, firstly 30 minutes of Pilates training, 10 minutes of rest and then 20 minutes of virtual reality will be applied. In the DBT group, 20 minutes of dynamic balance exercises will be applied after Pilates training. In dynamic balance training, exercises will consist of similar movements required by virtual reality games. The control group will be taught relaxation exercises and will be asked to perform the exercises 2 times for 8 weeks at home. Statistical analyses will be performed using the SPSS software version 15 (SPSS Inc. Chicago, IL, USA). The pre-training and post-training measurements of groups will be compared with the Wilcoxon Test. The significance level was set at p< 0.05.

Official Title
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Effects of Immersive Virtual Reality on Balance, Mobility, and Fatigue in Patients With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Virtual reality group
* Other: Dynamic Balance Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who are ambulatory and volunteer to participate to the study, in a stable phase of the disease, without relapses in the last 1 month, with an EDSS between 0-5,5. Exclusion Criteria: Participants who have orthopedic, vision, hearing, or perception problems Patients who have any cardiovascular or pulmonary disease in which exercise is contraindicated

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomize controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality group<br>In virtual reality group, 30 minutes of Pilates training, 10 minutes of rest and then 20 minutes of virtual reality will be applied. | Other: Virtual reality group<br>* Immersive virtual reality training protocol consisted of Football and Guillotine games.<br>|
| Active Comparator: Dynamic Balance Training<br>In the Dynamic Balance Training group, 20 minutes of dynamic balance exercises will be applied after Pilates training. | Other: Dynamic Balance Training<br>* Dynamic balance training protocol consisted of holding the ball and running away from the ball with a physiotherapist.<br>|
| No Intervention: Control group<br>The control group will be taught relaxation exercises and will be asked to perform the exercises at home. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale | Berg Balance Scale (BBS) rates performance from 0 (cannot perform) to 4 (normal performance) on 14 items. It has shown to be a valid measure with high inter and interrater reliability for people with MS. | Change between baseline and after 8 weeks of intervention will be assessed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go Test | Timed up and go test measures the time taken in seconds to arise from a standard chair, walk 3 m, turn through 180 degrees, walk back, and sit down again. | Change between baseline and after 8 weeks of intervention will be assessed | 
| Modified Sensory Organization Test | The Modified Sensory Organization Test, which is performed using computerized posturography, measures postural sway in response to 4 different sensory conditions is measured using a force platform. | Change between baseline and after 8 weeks of intervention will be assessed | 
| One-leg standing duration | One-leg standing duration is measured using chronometer. The time is started when participants lifted a foot from the ground to knee level. The test is terminated when the position disappears or 180 seconds passed. | Change between baseline and after 8 weeks of intervention will be assessed | 
| Activities-specific Balance Confidence | Activities-specific Balance Confidence (ABC) is a scale in which the patient rates his perceived level of confidence while performing 16 daily living activities. | Change between baseline and after 8 weeks of intervention will be assessed | 
| Fatigue Severity Scale | In the Fatigue Severity Scale (FSS), participants are asked to rate their fatigue level between 1 and 7 in the 9 statements (including motivation, exercise, physical functioning, carrying out duties, and interfering with work, family, or social life) during the last week. | Change between baseline and after 8 weeks of intervention will be assessed | 
| Fatigue Impact Scale | Fatigue impact scale consists of forty questions and evaluates the effects of fatigue on the 3 dimensions of daily life activities; cognitive function, physical function and psychosocial function. Each question is graded between 0 (no problem) and 4 (maximum problem). | Change between baseline and after 8 weeks of intervention will be assessed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, virtual reality, balance, mobility, fatigue