Clinical trial NCT04125823: Video Game-based Physical Activity Training in People With Multiple Sclerosis During Relapse Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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:

* Having neurological disorder other than multiple sclerosis
* Orthopaedic surgery history covering the foot, ankle, knee, hip, or spine, affecting balance and walking

Primary outcomes:
measure: Feasibility - Recruitment process: Number of people referred from physician and eligible for screening. Number of people attending interview with researcher.
timeFrame: Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
measure: Acceptability - Prospective acceptability: Barriers (screening interview).
timeFrame: Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
measure: Acceptability - Intervention coherence and adherence: Number of sessions attended.
timeFrame: Change from Baseline through Hospital Discharge, up to 10 days
measure: Acceptability - Experience (satisfaction, perceptions): Qualitative interview
timeFrame: Change from Baseline through Hospital Discharge, up to 10 days
Secondary outcomes:
measure: Timed 25-Foot Walk
timeFrame: Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
measure: 12-Item Multiple Sclerosis Walking Scale
timeFrame: Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
measure: Modified Fatigue Impact Scale
timeFrame: Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
measure: 2-Minute Walk Test
timeFrame: Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
measure: Six-Spot Step Test
timeFrame: Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
measure: Nine-Hole Peg Test
timeFrame: Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
measure: Manual Ability Measure-36
timeFrame: Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
measure: Epworth Sleepiness Scale
timeFrame: Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
measure: Multiple Sclerosis International Quality of Life Questionnaire
timeFrame: Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
measure: Hospital Anxiety and Depression Scale - Anxiety
timeFrame: Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
measure: Hospital Anxiety and Depression Scale - Depression
timeFrame: Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
measure: Symbol Digit Modalities Test
timeFrame: Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
measure: California Verbal Learning Test-II
timeFrame: Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
measure: Revised Brief Visuospatial Memory Test
timeFrame: Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
measure: Paced Auditory Serial Addition Test
timeFrame: Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University Hospital, Neurology Department
Study officials:
References: