Effects of Video Game-based Physical Activity Training in Persons With Multiple Sclerosis With Restless Legs Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Dokuz Eylul University
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- International Restless Legs Syndrome Study Group rating scale for restless legs syndrome
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
In this studly, the effects of an 8-week videogame-based physical activity training in persons with multiple sclerosis will be investigated.
Detailed Description
Multiple sclerosis is a chronic, progressive, and demyelinating disease of the central nervous system that affects more than 2.5 million people worldwide and is more common in young adults. The most common clinical signs and symptoms include fatigue, spasticity, cognitive impairment, chronic pain, depression, decreased quality of life, and bladder and bowel dysfunction. 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.
Investigators
Turhan Kahraman
Principal Investigator
Izmir Katip Celebi University
Eligibility Criteria
Inclusion Criteria
- •A relapsing-remitting or secondary progressive type of multiple sclerosis,
- •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
- •Another neurological disorder,
- •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
Outcomes
Primary Outcomes
International Restless Legs Syndrome Study Group rating scale for restless legs syndrome
Time Frame: Change from Baseline at 8 and 16 weeks
The International Restless Legs Syndrome Study Group rating scale for restless legs syndrome is used to assess severity of the restless legs syndrome symptoms. It consists of 10 items scored by 0 to 4. Possible scores range from 0 to 40. Higher scores indicate higher severity.
Secondary Outcomes
- Timed Up and Go test(Change from Baseline at 8 and 16 weeks)
- 6-Minute Walk Test(Change from Baseline at 8 and 16 weeks)
- 12-Item Multiple sclerosis walking scale(Change from Baseline at 8 and 16 weeks)
- Timed 25-Foot Walk(Change from Baseline at 8 and 16 weeks)
- Epworth Sleepiness Scale(Change from Baseline at 8 and 16 weeks)
- Hospital Anxiety And Depression Scale - Anxiety(Change from Baseline at 8 and 16 weeks)
- Multiple Sclerosis International Quality of Life questionnaire(Change from Baseline at 8 and 16 weeks)
- Multiple Sclerosis-Related Symptom Checklist(Change from Baseline at 8 and 16 weeks)
- Godin Leisure Time Exercise Questionnaire(Change from Baseline at 8 and 16 weeks)
- Modified Fatigue Impact Scale(Change from Baseline at 8 and 16 weeks)
- Hospital Anxiety And Depression Scale - Depression(Change from Baseline at 8 and 16 weeks)