Trials / Completed
CompletedNCT04125823
Video Game-based Physical Activity Training in People With Multiple Sclerosis During Relapse Treatment
Effects of Video Game-based Physical Activity Training in People With Multiple Sclerosis in the Inpatient Period During Relapse Treatment: a Pilot Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Dokuz Eylul University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study aims to investigate the feasibility and acceptability of the video game-based physical activity training program in the inpatient period during relapse treatment. The secondary aims are to investigate its effectiveness on upper extremity functions, walking, balance, cognitive functions, quality of life, depression, and fatigue comparing to conventional rehabilitation in persons with multiple sclerosis.
Detailed description
Multiple sclerosis (MS) is an inflammatory, demyelinating, neurodegenerative disease of the central nervous system. The most common clinical signs and symptoms are fatigue, spasticity, cognitive impairment, chronic pain, depression, decreased quality of life, and bladder and bowel dysfunction. Current medical treatment is divided into three groups: disease-modifying, symptom management, and prognosis and relapse management. Intravenous methylprednisolone treatment is generally used in the management of relapses and prognosis. It is also thought that physiotherapy during the intravenous methylprednisolone treatment provides better treatment results. Therefore, treatment planning of people with MS during hospitalization should be done by a multidisciplinary team. Studies have shown that video games based physical activity training as a non-pharmacological therapy may be an effective method for managing symptoms such as balance, gait, fatigue, and cognitive functions in people with MS, but its feasibility in the inpatient period is unknown. The primary aim of the study is to investigate the feasibility and acceptability of the video game-based physical activity training program in the inpatient period. The secondary aims are to investigate its effectiveness on upper extremity functions, walking, balance, cognitive functions, quality of life, depression, and fatigue in persons with MS comparing to conventional rehabilitation. Volunteers from people with MS who are in the inpatient period due to relapse in the Neurology Department, Faculty of Medicine, Dokuz Eylül University will participate in the study. In accordance with the inclusion criteria, 30 patients were randomly assigned to two groups: 15 patients in the game-based rehabilitation group and 15 patients in the conventional rehabilitation group. Based on the physical levels of the patients, appropriate games will be selected and video game based physical activity training will be started. Video games will be played with Xbox One with a motion sensor (Microsoft) and a 52'' Liquid Crystal Display. Depending on the prognosis of the patients, the grades and types of games will be changed. A conventional physiotherapy program including balance, upper extremity, and core stabilization exercises will be implemented. Treatments will be given by the physiotherapist for 45 minutes once daily during the hospital stay. Evaluations will be made before and after the treatment (discharge) and 4 weeks after the end of treatment. Physical and clinical evaluations will be made by physicians and physiotherapists, and cognitive evaluation will be performed by psychologists.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Video game-based physical activity training | Based on the physical levels of the patients, appropriate games will be selected and video game based physical activity training will be started. Video games will be played with Xbox One with a motion sensor (Microsoft) and a 52'' Liquid Crystal Display. Depending on the prognosis of the patients, the grades and types of games will be changed. Sessions will be performed by a physiotherapist for 45 minutes once a day during the hospital stay. |
| BEHAVIORAL | Conventional physiotherapy program | A conventional physiotherapy program including balance, upper extremity, and core stabilization exercises will be implemented. Sessions will be performed by a physiotherapist for 45 minutes once a day during the hospital stay. |
Timeline
- Start date
- 2019-10-23
- Primary completion
- 2022-01-15
- Completion
- 2022-02-15
- First posted
- 2019-10-14
- Last updated
- 2022-06-01
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT04125823. Inclusion in this directory is not an endorsement.