Clinical trial NCT03878810: Exergaming in Persons With Multiple Sclerosis With Restless Legs Syndrome
Official title: Effects of Video Game-based Physical Activity Training in Persons With Multiple Sclerosis With Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: International Restless Legs Syndrome Study Group rating scale for restless legs syndrome
timeFrame: Change from Baseline at 8 and 16 weeks
Secondary outcomes:
measure: Timed 25-Foot Walk
timeFrame: Change from Baseline at 8 and 16 weeks
measure: 12-Item Multiple sclerosis walking scale
timeFrame: Change from Baseline at 8 and 16 weeks
measure: Modified Fatigue Impact Scale
timeFrame: Change from Baseline at 8 and 16 weeks
measure: Timed Up and Go test
timeFrame: Change from Baseline at 8 and 16 weeks
measure: 6-Minute Walk Test
timeFrame: Change from Baseline at 8 and 16 weeks
measure: Epworth Sleepiness Scale
timeFrame: Change from Baseline at 8 and 16 weeks
measure: Godin Leisure Time Exercise Questionnaire
timeFrame: Change from Baseline at 8 and 16 weeks
measure: Hospital Anxiety And Depression Scale - Anxiety
timeFrame: Change from Baseline at 8 and 16 weeks
measure: Hospital Anxiety And Depression Scale - Depression
timeFrame: Change from Baseline at 8 and 16 weeks
measure: Multiple Sclerosis International Quality of Life questionnaire
timeFrame: Change from Baseline at 8 and 16 weeks
measure: Multiple Sclerosis-Related Symptom Checklist
timeFrame: Change from Baseline at 8 and 16 weeks
Other outcomes:
measure: Restless Legs Syndrome Diagnostic Criteria
timeFrame: At Baseline
measure: Expanded Disability Status Scale
timeFrame: At Baseline
Locations:
city: Izmir
country: Turkey
facility: MS Outpatient Clinic, Dokuz Eylul University Hospital
Study officials:
affiliation: Izmir Katip Celebi University
name: Serkan Ozakbas, MD
role: STUDY_DIRECTOR
References: