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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03501342
Enrollment
39
Registered
2018-04-18
Start date
2018-04-09
Completion date
2018-09-01
Last updated
2018-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, virtual reality, balance, mobility, fatigue

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.

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.

Interventions

OTHERVirtual reality group

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

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

Sponsors

Gazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

prospective randomize controlled study

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Berg Balance ScaleChange between baseline and after 8 weeks of intervention will be assessedBerg 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

MeasureTime frameDescription
Modified Sensory Organization TestChange between baseline and after 8 weeks of intervention will be assessedThe 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 durationChange between baseline and after 8 weeks of intervention will be assessedOne-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.
Timed Up and Go TestChange between baseline and after 8 weeks of intervention will be assessedTimed 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.
Fatigue Severity ScaleChange between baseline and after 8 weeks of intervention will be assessedIn 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 ScaleChange between baseline and after 8 weeks of intervention will be assessedFatigue 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).
Activities-specific Balance ConfidenceChange between baseline and after 8 weeks of intervention will be assessedActivities-specific Balance Confidence (ABC) is a scale in which the patient rates his perceived level of confidence while performing 16 daily living activities.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026