Exergaming in Persons With Multiple Sclerosis With Restless Legs Syndrome

Dokuz Eylül University (DEU)

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Exergaming

Study type: Interventional

Funder types: Other

Identifiers

NCT03878810

2019/01-138

Details and patient eligibility

About

In this studly, the effects of an 8-week videogame-based physical activity training in persons with multiple sclerosis will be investigated.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 4 patient groups

Exergaming, restless legs syndrome (+)

Experimental group

Description:

A video game-based physical activity training will be applied under a physiotherapist supervision for 2 days/week for 8 weeks.

Treatment:

Behavioral: Exergaming

Exergaming, restless legs syndrome (-)

Experimental group

Description:

A video game-based physical activity training will be applied under a physiotherapist supervision for 2 days/week for 8 weeks.

Treatment:

Behavioral: Exergaming

Control, restless legs syndrome (+)

No Intervention group

Description:

No specific intervention.

Control, restless legs syndrome (-)

No Intervention group

Description:

No specific intervention.