Effect of Video Game Based Physical Activity Training in Persons With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Game based physical activity training
Conventional physiotherapy
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis
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
Sites / Locations
- School of Physical Therapy and Rehabilitation, Dokuz Eylül University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Game based rehabilitation
Conventional rehabilitation
No intervention
Arm Description
Game based rehabilitation will be administered once a week for 8 weeks.
Conventional physiotherapy program will be administered once a week for 8 weeks.
Waitlist
Outcomes
Primary Outcome Measures
Nine-Hole Peg Test
The Nine-Hole Peg Test measures finger dexterity.
Secondary Outcome Measures
Expanded Disability Status Scale
Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis.
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.
Timed 25-Foot Walk
A clinical tool to evaluate patients for quantitative mobility and leg function performance test in a timed, 25 foot walk.
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.
Five Times Sit to Stand Test
A measure of functional lower limb muscle strength.
Sit-Up Test
The Sit-Up Test measures strength and endurance of the abdominals and hip-flexor muscles.
Activities-specific Balance Confidence Scale
Subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness.
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.
Beck Depression Inventory
The Beck Depression Inventory is one of the most widely used psychometric tests for measuring the severity of depression.
Modified Fatigue Impact Scale
The Modified Fatigue Impact Scale assesses the perceived impact of fatigue.
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.
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.
Full Information
NCT ID
NCT03045380
First Posted
February 3, 2017
Last Updated
November 17, 2017
Sponsor
Dokuz Eylul University
1. Study Identification
Unique Protocol Identification Number
NCT03045380
Brief Title
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
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Game based rehabilitation
Arm Type
Experimental
Arm Description
Game based rehabilitation will be administered once a week for 8 weeks.
Arm Title
Conventional rehabilitation
Arm Type
Active Comparator
Arm Description
Conventional physiotherapy program will be administered once a week for 8 weeks.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Waitlist
Intervention Type
Other
Intervention Name(s)
Game based physical activity training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nine-Hole Peg Test
Description
The Nine-Hole Peg Test measures finger dexterity.
Time Frame
Change from Baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Expanded Disability Status Scale
Description
Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis.
Time Frame
Baseline
Title
12-Item Multiple Sclerosis Walking Scale
Description
The 12-item multiple sclerosis walking scale is a self-report measure of the impact of multiple sclerosis on the individual's walking ability.
Time Frame
Change from Baseline at 8 weeks
Title
Timed 25-Foot Walk
Description
A clinical tool to evaluate patients for quantitative mobility and leg function performance test in a timed, 25 foot walk.
Time Frame
Change from Baseline at 8 weeks
Title
Six-Spot Step Test
Description
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.
Time Frame
Change from Baseline at 8 weeks
Title
Five Times Sit to Stand Test
Description
A measure of functional lower limb muscle strength.
Time Frame
Change from Baseline at 8 weeks
Title
Sit-Up Test
Description
The Sit-Up Test measures strength and endurance of the abdominals and hip-flexor muscles.
Time Frame
Change from Baseline at 8 weeks
Title
Activities-specific Balance Confidence Scale
Description
Subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness.
Time Frame
Change from Baseline at 8 weeks
Title
Manual Ability Measure-36
Description
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.
Time Frame
Change from Baseline at 8 weeks
Title
Beck Depression Inventory
Description
The Beck Depression Inventory is one of the most widely used psychometric tests for measuring the severity of depression.
Time Frame
Change from Baseline at 8 weeks
Title
Modified Fatigue Impact Scale
Description
The Modified Fatigue Impact Scale assesses the perceived impact of fatigue.
Time Frame
Change from Baseline at 8 weeks
Title
Multiple Sclerosis International Quality of Life Questionnaire
Description
The Multiple Sclerosis International Quality of Life Questionnaire is a multi-dimensional, self-administered, disease specific quality of life scale.
Time Frame
Change from Baseline at 8 weeks
Title
Brief International Cognitive Assessment for Multiple Sclerosis
Description
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.
Time Frame
Change from Baseline at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
School of Physical Therapy and Rehabilitation, Dokuz Eylül University
City
Izmir
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Video Game Based Physical Activity Training in Persons With Multiple Sclerosis
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