Clinical trial NCT03045380: Effect of Video Game Based Physical Activity Training in Persons With Multiple Sclerosis
Official title: Effect of Video Game Based Physical Activity Training on Upper Extremity Functions, Walking, Balance and Cognitive Functions in Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was designed to investigate the effect of video games based physical activity training on upper extremity functions, walking, balance and cognitive functions in persons with multiple sclerosis (MS). For this aim, the participants with MS will be divided into three groups: game based physical activity training, conventional rehabilitation, and no intervention groups. The experimental groups will receive therapy sessions once a week for 8 weeks. The no intervention group will receive no intervention, they will be assessed at baseline and after 8 weeks.

Detailed description: MS is an inflammatory, demyelinating, and neurodegenerative disease of the central nervous system. The most common clinical signs and symptoms are fatigue, spasticity, affecting mobility, cognitive impairment, chronic pain, depression, decreased quality of life, and bladder and bowel dysfunction.

In order to increase and maintain the quality of life of individuals with MS these disease-related progressive symptoms need to be managed. For this reason, patients 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, tremor, fatigue, cognitive functions in persons with MS.

The primary purpose of the study was to examine the effects and persistence of 8-week video games-based physical activity training in MS patients on upper extremity functions, walking, balance, cognitive functions, quality of life, depression and fatigue. The second aim of the study was to investigate the effect and persistence of traditional physiotherapy of 8 weeks on MS patients on upper extremity functions, walking, balance, cognitive functions, quality of life, depression and fatigue. The third aim of the study is to compare the effects of 8-week videogame-based physical activity training and traditional physiotherapy in MS patients.

Volunteers from persons with MS who are in routine control of the MS Outpatient Clinic of Neurology Department, Faculty of Medicine, Dokuz Eylül University will participate in the study. In accordance with the inclusion criteria, 51 patients were randomly assigned to three groups: 17 patients in the game based rehabilitation group, 17 patients in the conventional rehabilitation group and 17 patients in the no intervention 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 motion sensor (Microsoft) and a 52'' Liquid Crystal Display. Depending on the prognosis of the patients, the grades of the games and types of the games will be changed. The program will be administered once a week for 8 weeks. A conventional physiotherapy program including balance, upper extremity, and core stabilization exercises will be implemented. Sessions will take 5-10 minutes warm up, 15-20 minutes exercise and 5-10 minute cool down periods. The program will be administered once a week for 8 weeks. No intervention group formed from waitlist will receive no intervention.

Eligibility criteria: Inclusion Criteria:

* Relapsing-remitting or secondary progressive multiple sclerosis
* Able to walk at least 100 meters without resting
* Able to stand for at least half an hour
* Willingness to participate in the study

Exclusion Criteria:

* Neurological disease other than multiple sclerosis
* A relapse during the study
* Having undergone orthopedic surgery involving the foot-ankle, knee, hip, spine, affecting balance
* Serious cognitive or psychiatric disorder

Primary outcomes:
measure: Nine-Hole Peg Test
timeFrame: Change from Baseline at 8 weeks
Secondary outcomes:
measure: Expanded Disability Status Scale
timeFrame: Baseline
measure: 12-Item Multiple Sclerosis Walking Scale
timeFrame: Change from Baseline at 8 weeks
measure: Timed 25-Foot Walk
timeFrame: Change from Baseline at 8 weeks
measure: Six-Spot Step Test
timeFrame: Change from Baseline at 8 weeks
measure: Five Times Sit to Stand Test
timeFrame: Change from Baseline at 8 weeks
measure: Sit-Up Test
timeFrame: Change from Baseline at 8 weeks
measure: Activities-specific Balance Confidence Scale
timeFrame: Change from Baseline at 8 weeks
measure: Manual Ability Measure-36
timeFrame: Change from Baseline at 8 weeks
measure: Beck Depression Inventory
timeFrame: Change from Baseline at 8 weeks
measure: Modified Fatigue Impact Scale
timeFrame: Change from Baseline at 8 weeks
measure: Multiple Sclerosis International Quality of Life Questionnaire
timeFrame: Change from Baseline at 8 weeks
measure: Brief International Cognitive Assessment for Multiple Sclerosis
timeFrame: Change from Baseline at 8 weeks
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: School of Physical Therapy and Rehabilitation, Dokuz Eylül University
Study officials:
References: