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

NCT03501342 | Completed

• 1 other identifier: 228
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; virtual reality; balance; mobility; fatigue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Timed Up and Go Test

  Change between baseline and after 8 weeks of intervention will be assessed

• Modified Sensory Organization Test

  Change between baseline and after 8 weeks of intervention will be assessed

• One-leg standing duration

  Change between baseline and after 8 weeks of intervention will be assessed

• Activities-specific Balance Confidence

  Change between baseline and after 8 weeks of intervention will be assessed

• Fatigue Severity Scale

  Change between baseline and after 8 weeks of intervention will be assessed

Study Arms (3)

Virtual reality group

EXPERIMENTAL

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

Dynamic Balance Training

ACTIVE COMPARATOR

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

Other: Dynamic Balance Training

Control group

NO INTERVENTION

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

Interventions

Virtual reality group OTHER

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

Virtual reality group

Dynamic Balance Training OTHER

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

Dynamic Balance Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants who have orthopedic, vision, hearing, or perception problems
• Patients who have any cardiovascular or pulmonary disease in which exercise is contraindicated

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 18489806 BACKGROUND

• 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.

  PMID: 19026963 BACKGROUND

• 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.

  PMID: 17293726 BACKGROUND

• 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.

  PMID: 17337007 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cagla Ozkul

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: prospective randomize controlled study

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: April 18, 2018
• Study Start: April 9, 2018
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 12, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)