Multiple SclerosisNCT03045380
Effect of Video Game Based Physical Activity Training in Persons With Multiple Sclerosis
A study testing Game based physical activity training and Conventional physiotherapy in people with Multiple Sclerosis, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Game based physical activity training and Conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
School of Physical Therapy and Rehabilitation, Dokuz Eylül University
Izmir
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Game based physical activity training, Conventional physiotherapy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game based physical activity trainingOther
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 physiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Game based rehabilitation | Experimental | Game based rehabilitation will be administered once a week for 8 weeks. Receives: Other: Game based physical activity training |
| Conventional rehabilitation | Active comparator | Conventional physiotherapy program will be administered once a week for 8 weeks. Receives: Other: Conventional physiotherapy |
| No intervention | No intervention | Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nine-Hole Peg Test
The Nine-Hole Peg Test measures finger dexterity.
Measured: Change from Baseline at 8 weeks
Secondary outcomes (12)
Expanded Disability Status Scale
Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline at 8 weeks
Five Times Sit to Stand Test
A measure of functional lower limb muscle strength.
Measured: Change from Baseline at 8 weeks
Sit-Up Test
The Sit-Up Test measures strength and endurance of the abdominals and hip-flexor muscles.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline at 8 weeks
Modified Fatigue Impact Scale
The Modified Fatigue Impact Scale assesses the perceived impact of fatigue.
Measured: 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.
Measured: 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.
Measured: Change from Baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study startNov 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Turhan Kahraman, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045380
- Sponsor's protocol ID
- 2996-GOA
- Status last verified
- Nov 2017
- First submitted
- 3 Feb 2017
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Video Game Based Physical Activity Training on Upper Extremity Functions, Walking, Balance and Cognitive Functions in Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03045380
- Acronym / sponsor ID
- 2996-GOA
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Game based rehabilitation | Experimental | Other: Game based physical activity trainingGame based rehabilitation will be administered once a week for 8 weeks. |
| Conventional rehabilitation | Active comparator | Other: Conventional physiotherapyConventional physiotherapy program will be administered once a week for 8 weeks. |
| No intervention | No intervention | –Waitlist |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Game based physical activity trainingBased 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. | Other | Game based rehabilitation |
| Conventional physiotherapyA 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. | Other | Conventional rehabilitation |
Primary outcome
Nine-Hole Peg Test
Time frame: Change from Baseline at 8 weeks
The Nine-Hole Peg Test measures finger dexterity.
12 secondary outcomes
Expanded Disability Status Scale
Time frame: Baseline
12-Item Multiple Sclerosis Walking Scale
Time frame: Change from Baseline at 8 weeks
Timed 25-Foot Walk
Time frame: Change from Baseline at 8 weeks
Six-Spot Step Test
Time frame: Change from Baseline at 8 weeks
Five Times Sit to Stand Test
Time frame: Change from Baseline at 8 weeks
Sit-Up Test
Time frame: Change from Baseline at 8 weeks
Activities-specific Balance Confidence Scale
Time frame: Change from Baseline at 8 weeks
Manual Ability Measure-36
Time frame: Change from Baseline at 8 weeks
Beck Depression Inventory
Time frame: Change from Baseline at 8 weeks
Modified Fatigue Impact Scale
Time frame: Change from Baseline at 8 weeks
Multiple Sclerosis International Quality of Life Questionnaire
Time frame: Change from Baseline at 8 weeks
Brief International Cognitive Assessment for Multiple Sclerosis
Time frame: Change from Baseline at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game based physical activity training and Conventional physiotherapy in people with Multiple Sclerosis, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nine-Hole Peg Test (time frame: Change from Baseline at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.