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Comparison of Two Different Virtual Reality Methods in Patients With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nintendo Wii Fit Balance exercises
Balance Trainer Balance Exercises
Sponsored by
Biruni University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, rehabilitation, postural balance, exercise

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • . Participants who were ambulatory and volunteer to participate to the study, in a stable phase of the disease, without relapses or worsening in the last 3 months, with an EDSS between 2.5-6 and aged between 25 to 60 years

Exclusion Criteria:

  • physical activity more than 150 minutes per week, were pregnant, had blurred vision, had psychiatric problems, or severe cognitive impairment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Nintendo Wii Fit

    Balance Trainer

    Control

    Arm Description

    Participants in the Nintendo Wii group were included to exercise program that consisted of 16 individual PT-supervised sessions (two 60-minute sessions/week), which were prepared to improve balance. Each session started with 10 minutes of non-resistance cycling work for warm-up.

    Participants in the Balance Trainer group were included to exercise program that consisted of 16 individual PT-supervised sessions (two 60-minute sessions/week), which were prepared to improve balance. Each session started with 10 minutes of non-resistance cycling work for warm-up.

    Patients in the 'Group III-control group' were included in the waiting list until the end of the study.

    Outcomes

    Primary Outcome Measures

    Berg Balance Scale
    The Berg Balance Scale is a 56-point scale designed to measure balance among older people by the assessment of functional tasks. Its concurrent validity has been established for people with multiple sclerosis. The Berg Balance Scale is a five point ordinal scale and consisting of 14 balance activity. Each activity is scored between 0-4 and higher total scores indicating less impaired balance. 45-56=independent, 21-44=assisted walking, 0-20=dependent.

    Secondary Outcome Measures

    Timed Up and Go Test
    The patient's mobility requiring both static and dynamic balance was assessed by Timed up and go test which 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. A longer completion time indicates a higher risk of falling.
    Six Minutes Walk Test
    Patients were instructed to walk a 30 m corridor for 6 minutes and the distance completed after 6 minutes (6MWD) was recorded.
    Fatigue Severity Scale
    Fatigue severity scale is a nine-item, self-administered questionnaire that assesses the fatigue level in daily functions of MS patients. The items are scored on a 7 point scale with 1=strongly disagree and 7=strongly agree. The minimum score=9 and maximum score=63. Higher fatigue severity scale scores indicating greater severity of fatigue.

    Full Information

    First Posted
    December 11, 2017
    Last Updated
    February 12, 2018
    Sponsor
    Biruni University
    Collaborators
    Istanbul University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03436927
    Brief Title
    Comparison of Two Different Virtual Reality Methods in Patients With Multiple Sclerosis
    Official Title
    Comparison of the Effects of Two Different Virtual Reality Treatment Methods in Patients With Multiple Sclerosis: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 15, 2016 (Actual)
    Primary Completion Date
    July 15, 2017 (Actual)
    Study Completion Date
    July 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Biruni University
    Collaborators
    Istanbul University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    As a chronic, autoimmune, inflammatory disease of the central nervous system, Multiple Sclerosis (MS) is a neurologic problem which the most frequent cause of disability in young adults. Fatigue, pain, spasticity, muscle weakness, depression, as well as balance and gait disorders are amongst the symptoms of MS. Balance disorders and the falls caused by them are the most frequent problems which result in disability of MS patients, with 75% of all patients being affected during the course of disease. When considering previous studies carried out on physiotherapy and rehabilitation practices in the light of balance disorders and other related problems faced by MS patients, it can been that various physiotherapeutic approaches are applied with varying follow-up times and in the form of hospital sessions, home sessions, or group training. Posture and balance problems in MS patients are tried to be solved through long-lasting treatment sessions using traditional methods of physiotherapy, where less patient participation is observed. Fatigue, psychological impairment, and insufficient motivation are other aspects which influence the success of treatment and which need to be addressed in MS patients. In contrast to traditional methods of physiotherapy applied in form of long-lasting treatment sessions, technology-supported rehabilitation approaches have emerged in recent years. It can be seen that different systems have started to be employed in the physiotherapy of many chronic diseases, either alone or in company with traditional methods. Even though the clinical use of these systems is becoming widespread, there are certain gaps in terms of the systems' impacts, comparative advantages, or cost effectiveness. Keeping this in mind, the purpose of this study is to investigate and compare the impacts of 'Nintendo Wii Fit' and 'Balance Trainer', as two of the technologic methods with therapeutic impact which have started to be used for different diagnosis groups in recent years, on the balance and posture parameters of MS patients, with the ultimate aim to introduce a whole new point of view to traditional physiotherapy and rehabilitation studies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis
    Keywords
    Multiple Sclerosis, rehabilitation, postural balance, exercise

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nintendo Wii Fit
    Arm Type
    Experimental
    Arm Description
    Participants in the Nintendo Wii group were included to exercise program that consisted of 16 individual PT-supervised sessions (two 60-minute sessions/week), which were prepared to improve balance. Each session started with 10 minutes of non-resistance cycling work for warm-up.
    Arm Title
    Balance Trainer
    Arm Type
    Experimental
    Arm Description
    Participants in the Balance Trainer group were included to exercise program that consisted of 16 individual PT-supervised sessions (two 60-minute sessions/week), which were prepared to improve balance. Each session started with 10 minutes of non-resistance cycling work for warm-up.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Patients in the 'Group III-control group' were included in the waiting list until the end of the study.
    Intervention Type
    Other
    Intervention Name(s)
    Nintendo Wii Fit Balance exercises
    Intervention Description
    Nintendo Wii Fit' training protocol consisted of 'Penguin Slide', 'Table Tilt', 'Ski Slalom', 'Heading' and 'Balance Bubble' games that selected from the Wii Fit Plus balance games section
    Intervention Type
    Other
    Intervention Name(s)
    Balance Trainer Balance Exercises
    Intervention Description
    Balance Trainer' training protocol consisted of 'Collect Apples', 'Outline', 'Paddle War' and 'Evaluation of Movement' games which were included in the device software and allowed the patients to done balance exercises in different directions.
    Primary Outcome Measure Information:
    Title
    Berg Balance Scale
    Description
    The Berg Balance Scale is a 56-point scale designed to measure balance among older people by the assessment of functional tasks. Its concurrent validity has been established for people with multiple sclerosis. The Berg Balance Scale is a five point ordinal scale and consisting of 14 balance activity. Each activity is scored between 0-4 and higher total scores indicating less impaired balance. 45-56=independent, 21-44=assisted walking, 0-20=dependent.
    Time Frame
    Change between baseline and after 8 weeks of intervention were assessed.
    Secondary Outcome Measure Information:
    Title
    Timed Up and Go Test
    Description
    The patient's mobility requiring both static and dynamic balance was assessed by Timed up and go test which 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. A longer completion time indicates a higher risk of falling.
    Time Frame
    Change between baseline and after 8 weeks of intervention were assessed.
    Title
    Six Minutes Walk Test
    Description
    Patients were instructed to walk a 30 m corridor for 6 minutes and the distance completed after 6 minutes (6MWD) was recorded.
    Time Frame
    Change between baseline and after 8 weeks of intervention were assessed.
    Title
    Fatigue Severity Scale
    Description
    Fatigue severity scale is a nine-item, self-administered questionnaire that assesses the fatigue level in daily functions of MS patients. The items are scored on a 7 point scale with 1=strongly disagree and 7=strongly agree. The minimum score=9 and maximum score=63. Higher fatigue severity scale scores indicating greater severity of fatigue.
    Time Frame
    Change between baseline and after 8 weeks of intervention were assessed.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: . Participants who were ambulatory and volunteer to participate to the study, in a stable phase of the disease, without relapses or worsening in the last 3 months, with an EDSS between 2.5-6 and aged between 25 to 60 years Exclusion Criteria: physical activity more than 150 minutes per week, were pregnant, had blurred vision, had psychiatric problems, or severe cognitive impairment.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Comparison of Two Different Virtual Reality Methods in Patients With Multiple Sclerosis

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