Exergaming in Persons With Multiple Sclerosis With Restless Legs Syndrome
NCT ID: NCT03878810
Last Updated: 2022-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
65 participants
INTERVENTIONAL
2019-03-29
2021-12-15
Brief Summary
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Detailed Description
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Sleep disturbance is affecting more than 50% of persons with multiple sclerosis. Restless legs syndrome is one of the factors causing sleep disturbance in persons with multiple sclerosis. Studies have showed that the incidence of restless legs syndrome in persons with multiple sclerosis is about five times more than the general population.
In order to increase and maintain the quality of life of persons with multiple sclerosis, the disease-related progressive symptoms need to be managed. Therefore, persons with multiple sclerosis need long-term rehabilitation. This situation reduces the motivation of the people over time and makes the continuity of treatment difficult. Developments in rehabilitation technology aim to contribute to the treatment process as well as to increase the active participation of individuals with chronic diseases.
Current literature has shown that video-based physical activity training as non-pharmacological therapy may be an effective method for symptoms such as balance, walking, fatigue, cognitive functions in persons with multiple sclerosis, but the effects on restless legs syndrome are not known.
The main aim of the study is to investigate the effects of 8-week video game-based physical activity training in persons with multiple sclerosis with restless legs syndrome.
Persons who followed by the outpatient Multiple Sclerosis Clinic of Dokuz Eylül University Hospital will participate in the study. A total of 68 participants will randomly be divided into 4 groups as exergaming group and control group with restless legs syndrome, exergaming group and control group without restless legs syndrome.
A video game-based physical activity training will apply to exergaming groups by a physiotherapist for 2 days/week. The control groups will continue their routine treatment during the study. After the study, the treatment options will be offered to the participants. Assessments will done at baseline, after 8 weeks (post-treatment) and at 8 weeks (follow-up). Assessments will be done by assessors who are blinded to the group allocation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Exergaming, restless legs syndrome (+)
A video game-based physical activity training will be applied under a physiotherapist supervision for 2 days/week for 8 weeks.
Exergaming
A video game-based physical activity training applied using a commercial game console.
Exergaming, restless legs syndrome (-)
A video game-based physical activity training will be applied under a physiotherapist supervision for 2 days/week for 8 weeks.
Exergaming
A video game-based physical activity training applied using a commercial game console.
Control, restless legs syndrome (+)
No specific intervention.
No interventions assigned to this group
Control, restless legs syndrome (-)
No specific intervention.
No interventions assigned to this group
Interventions
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Exergaming
A video game-based physical activity training applied using a commercial game console.
Eligibility Criteria
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Inclusion Criteria
* Being able to walk at least 100 meters without resting,
* Being able to stably stand for half an hour,
* To be willing to participate in the study.
Exclusion Criteria
* Relapse during the study period,
* Orthopedic surgery history including the ankle-foot, knee, hip, or spine, affecting balance,
* Diagnosed severe cognitive and/or psychiatric impairment
18 Years
65 Years
ALL
No
Sponsors
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Dokuz Eylul University
OTHER
Responsible Party
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Turhan Kahraman
Principal Investigator
Principal Investigators
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Serkan Ozakbas, MD
Role: STUDY_DIRECTOR
Izmir Katip Celebi University
Locations
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MS Outpatient Clinic, Dokuz Eylul University Hospital
Izmir, , Turkey (Türkiye)
Countries
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Other Identifiers
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2019/01-138
Identifier Type: -
Identifier Source: org_study_id
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