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

NCT ID: NCT03501342

Last Updated: 2018-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-09
• Study Completion Date: 2018-09-01

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual reality group

Intervention Type: OTHER

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

Dynamic Balance Training

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

Group Type: ACTIVE_COMPARATOR

Dynamic Balance Training

Intervention Type: OTHER

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

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dynamic Balance Training

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

Intervention Type: OTHER

Virtual reality group

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Cagla Ozkul

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cagla Ozkul

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

Gazi University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Sahin F, Yilmaz F, Ozmaden A, Kotevolu N, Sahin T, Kuran B. Reliability and validity of the Turkish version of the Berg Balance Scale. J Geriatr Phys Ther. 2008;31(1):32-7. doi: 10.1519/00139143-200831010-00006.

Reference Type: BACKGROUND

PMID: 18489806 (View on PubMed)

Yelnik A, Bonan I. Clinical tools for assessing balance disorders. Neurophysiol Clin. 2008 Dec;38(6):439-45. doi: 10.1016/j.neucli.2008.09.008. Epub 2008 Oct 18.

Reference Type: BACKGROUND

PMID: 19026963 (View on PubMed)

Armutlu K, Korkmaz NC, Keser I, Sumbuloglu V, Akbiyik DI, Guney Z, Karabudak R. The validity and reliability of the Fatigue Severity Scale in Turkish multiple sclerosis patients. Int J Rehabil Res. 2007 Mar;30(1):81-5. doi: 10.1097/MRR.0b013e3280146ec4.

Reference Type: BACKGROUND

PMID: 17293726 (View on PubMed)

Armutlu K, Keser I, Korkmaz N, Akbiyik DI, Sumbuloglu V, Guney Z, Karabudak R. Psychometric study of Turkish version of Fatigue Impact Scale in multiple sclerosis patients. J Neurol Sci. 2007 Apr 15;255(1-2):64-8. doi: 10.1016/j.jns.2007.01.073. Epub 2007 Mar 6.

Reference Type: BACKGROUND

PMID: 17337007 (View on PubMed)

Other Identifiers

228

Identifier Type: -

Identifier Source: org_study_id