Skip to main content
OpenTrials
Completed

NCT Number: NCT03501342

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Group

Other

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

Dynamic Balance training

Other

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

Primary outcomes

  1. Berg Balance Scale

    Time frame: 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 outcomes

  1. Timed Up and Go Test

    Time frame: 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.

  2. Modified Sensory Organization Test

    Time frame: 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.

  3. One-leg standing duration

    Time frame: 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.

  4. Activities-specific Balance Confidence

    Time frame: 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.

  5. Fatigue Severity Scale

    Time frame: 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.

  6. Fatigue Impact Scale

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2018
Registry last updated
Oct 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.