Effect of Video Game Based Physical Activity Training in Persons With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Effect of Video Game Based Physical Activity Training on Upper Extremity Functions, Walking, Balance and Cognitive Functions in Persons With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03045380
• Other study ID #: 2996-GOA
• Status: Completed
• Phase: N/A
• First received: February 3, 2017
• Last updated: November 17, 2017
• Start date: November 2016
• Est. completion date: June 2017

Study information

• Verified date: November 2017
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• 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 motion sensor (Microsoft) and a 50'' Liquid Crystal Display. Depending on the prognosis of the patients, the grades of the games and types of the games will be changed. A game based physical activity training session takes 30 to 45 minutes. The program will be administered once a week for 8 weeks.
• Conventional physiotherapy
A conventional physiotherapy program including balance, upper extremity, and core stabilization exercises will be implemented. A conventional physiotherapy session takes 30 to 45 minutes. The program will be administered once a week for 8 weeks.

Locations

Country	Name	City	State
Turkey	School of Physical Therapy and Rehabilitation, Dokuz Eylül University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nine-Hole Peg Test	The Nine-Hole Peg Test measures finger dexterity.	Change from Baseline at 8 weeks
Secondary	Expanded Disability Status Scale	Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis.	Baseline
Secondary	12-Item Multiple Sclerosis Walking Scale	The 12-item multiple sclerosis walking scale is a self-report measure of the impact of multiple sclerosis on the individual's walking ability.	Change from Baseline at 8 weeks
Secondary	Timed 25-Foot Walk	A clinical tool to evaluate patients for quantitative mobility and leg function performance test in a timed, 25 foot walk.	Change from Baseline at 8 weeks
Secondary	Six-Spot Step Test	Six-Spot Step Test reflects a complex array of sensori-motor functions, part of which are lower limb strength, spasticity and coordination, as well as balance.	Change from Baseline at 8 weeks
Secondary	Five Times Sit to Stand Test	A measure of functional lower limb muscle strength.	Change from Baseline at 8 weeks
Secondary	Sit-Up Test	The Sit-Up Test measures strength and endurance of the abdominals and hip-flexor muscles.	Change from Baseline at 8 weeks
Secondary	Activities-specific Balance Confidence Scale	Subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness.	Change from Baseline at 8 weeks
Secondary	Manual Ability Measure-36	The Manual Ability Measurement is a questionnaire on perceived ease or difficulty that a persons may experience when performing unilateral and bilateral activities of daily living tasks.	Change from Baseline at 8 weeks
Secondary	Beck Depression Inventory	The Beck Depression Inventory is one of the most widely used psychometric tests for measuring the severity of depression.	Change from Baseline at 8 weeks
Secondary	Modified Fatigue Impact Scale	The Modified Fatigue Impact Scale assesses the perceived impact of fatigue.	Change from Baseline at 8 weeks
Secondary	Multiple Sclerosis International Quality of Life Questionnaire	The Multiple Sclerosis International Quality of Life Questionnaire is a multi-dimensional, self-administered, disease specific quality of life scale.	Change from Baseline at 8 weeks
Secondary	Brief International Cognitive Assessment for Multiple Sclerosis	The Brief International Cognitive Assessment for Multiple Sclerosis is an international initiative to recommend and support a cognitive assessment that is brief, practical and universal. It includes tests of mental processing speed and memory.	Change from Baseline at 8 weeks