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Video Game-based Physical Activity Training in People With Multiple Sclerosis During Relapse Treatment

D

Dokuz Eylül University (DEU)

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Behavioral: Conventional physiotherapy program
Behavioral: Video game-based physical activity training

Study type

Interventional

Funder types

Other

Identifiers

NCT04125823
4992-GOA

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Video game-based physical activity training
Experimental group
Treatment:
Behavioral: Video game-based physical activity training
Conventional physiotherapy program
Active Comparator group
Treatment:
Behavioral: Conventional physiotherapy program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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