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

Sponsor

Gazi University (Other)

Overall Status

Completed

CT.gov ID

NCT03501342

Collaborator

(none)

Enrollment

Location

Arms

4.8

Actual Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Other: Virtual reality group Other: Dynamic Balance Training	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective randomize controlled studyprospective randomize controlled study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 9, 2018

Actual Primary Completion Date :

Sep 1, 2018

Actual Study Completion Date :

Sep 1, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Virtual reality group

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

Immersive virtual reality training protocol consisted of "Football" and "Guillotine" games.

Active Comparator: Dynamic Balance Training

In the "Dynamic Balance Training" group, 20 minutes of dynamic balance exercises will be applied after Pilates training.

Other: Dynamic Balance Training

Dynamic balance training protocol consisted of holding the ball and running away from the ball with a physiotherapist.

No Intervention: Control group

The control group will be taught relaxation exercises and will be asked to perform the exercises at home.

Outcome Measures

Primary Outcome Measures

Berg Balance Scale [Change between baseline and after 8 weeks of intervention will be assessed]
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.

Secondary Outcome Measures

Timed Up and Go Test [Change between baseline and after 8 weeks of intervention will be assessed]
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.
Modified Sensory Organization Test [Change between baseline and after 8 weeks of intervention will be assessed]
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.
One-leg standing duration [Change between baseline and after 8 weeks of intervention will be assessed]
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.
Activities-specific Balance Confidence [Change between baseline and after 8 weeks of intervention will be assessed]
Activities-specific Balance Confidence (ABC) is a scale in which the patient rates his perceived level of confidence while performing 16 daily living activities.
Fatigue Severity Scale [Change between baseline and after 8 weeks of intervention will be assessed]
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.
Fatigue Impact Scale [Change between baseline and after 8 weeks of intervention will be assessed]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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