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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Game based physical activity training; Other: Conventional physiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey
    • School of Physical Therapy and Rehabilitation, Dokuz Eylül University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Game based rehabilitation; Game based rehabilitation will be administered once a week for 8 weeks.	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.
ACTIVE_COMPARATOR: Conventional rehabilitation; Conventional physiotherapy program will be administered once a week for 8 weeks.	Other: 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.
NO_INTERVENTION: No intervention; Waitlist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nine-Hole Peg Test	The Nine-Hole Peg Test measures finger dexterity.	Change from Baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expanded Disability Status Scale	Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis.	Baseline
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
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
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
Five Times Sit to Stand Test	A measure of functional lower limb muscle strength.	Change from Baseline at 8 weeks
Sit-Up Test	The Sit-Up Test measures strength and endurance of the abdominals and hip-flexor muscles.	Change from Baseline at 8 weeks
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
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
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
Modified Fatigue Impact Scale	The Modified Fatigue Impact Scale assesses the perceived impact of fatigue.	Change from Baseline at 8 weeks
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
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

Collaborators and Investigators

• Sponsor: Dokuz Eylul University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2016
• Primary Completion (ACTUAL): June 1, 2017
• Study Completion (ACTUAL): June 1, 2017

Study Registration Dates

• First Submitted: February 3, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (ESTIMATE): February 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2017
• Last Update Submitted That Met QC Criteria: November 17, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 2996-GOA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No