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

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ClinicalTrials.gov Identifier: NCT03501342
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Cagla Ozkul, Gazi University

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective 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 : April 9, 2018
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501342


Locations
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Turkey
Gazi University
Ankara, Turkey
Sponsors and Collaborators
Gazi University
Investigators
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Principal Investigator: Cagla Ozkul Gazi University

Publications:
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Responsible Party: Cagla Ozkul, Research Assistant, Gazi University
ClinicalTrials.gov Identifier: NCT03501342     History of Changes
Other Study ID Numbers: 228
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cagla Ozkul, Gazi University:
Multiple Sclerosis
virtual reality
balance
mobility
fatigue
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms