Multiple SclerosisNCT03436927
Comparison of Two Different Virtual Reality Methods in Patients With Multiple Sclerosis
A study testing Nintendo Wii Fit Balance exercises and Balance Trainer Balance Exercises in people with Multiple Sclerosis, run by Biruni University.
Trial summary
As a chronic, autoimmune, inflammatory disease of the central nervous system, Multiple Sclerosis (MS) is a neurologic problem which the most frequent cause of disability in young adults. Fatigue, pain, spasticity, muscle weakness, depression, as well as balance and gait disorders are amongst the symptoms of MS. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Nintendo Wii Fit Balance exercises and Balance Trainer Balance Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2016to 15 Jul 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- . Participants who were ambulatory and volunteer to participate to the study, in a stable phase of the disease, without relapses or worsening in the last 3 months, with an EDSS between 2.5-6 and aged between 25 to 60 years
Who cannot join
- physical activity more than 150 minutes per week, were pregnant, had blurred vision, had psychiatric problems, or severe cognitive impairment.
About this study
Official title: Comparison of the Effects of Two Different Virtual Reality Treatment Methods in Patients With Multiple Sclerosis: A Randomized Controlled Trial
As a chronic, autoimmune, inflammatory disease of the central nervous system, Multiple Sclerosis (MS) is a neurologic problem which the most frequent cause of disability in young adults. Fatigue, pain, spasticity, muscle weakness, depression, as well as balance and gait disorders are amongst the symptoms of MS. Balance disorders and the falls caused by them are the most frequent problems which result in disability of MS patients, with 75% of all patients being affected during the course of disease. When considering previous studies carried out on physiotherapy and rehabilitation practices in the light of balance disorders and other related problems faced by MS patients, it can been that various physiotherapeutic approaches are applied with varying follow-up times and in the form of hospital sessions, home sessions, or group training. Posture and balance problems in MS patients are tried to be solved through long-lasting treatment sessions using traditional methods of physiotherapy, where less patient participation is observed. Fatigue, psychological impairment, and insufficient motivation are other aspects which influence the success of treatment and which need to be addressed in MS patients. In contrast to traditional methods of physiotherapy applied in form of long-lasting treatment sessions, technology-supported rehabilitation approaches have emerged in recent years. It can be seen that different systems have started to be employed in the physiotherapy of many chronic diseases, either alone or in company with traditional methods. Even though the clinical use of these systems is becoming widespread, there are certain gaps in terms of the systems' impacts, comparative advantages, or cost effectiveness. Keeping this in mind, the purpose of this study is to investigate and compare the impacts of 'Nintendo Wii Fit' and 'Balance Trainer', as two of the technologic methods with therapeutic impact which have started to be used for different diagnosis groups in recent years, on the balance and posture parameters of MS patients, with the ultimate aim to introduce a whole new point of view to traditional physiotherapy and rehabilitation studies.
- Conditions
- Multiple Sclerosis
- Being tested
- Nintendo Wii Fit Balance exercises, Balance Trainer Balance Exercises
- Keywords
- Multiple Sclerosis, rehabilitation, postural balance, exercise
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintendo Wii Fit Balance exercisesOther
Nintendo Wii Fit' training protocol consisted of 'Penguin Slide', 'Table Tilt', 'Ski Slalom', 'Heading' and 'Balance Bubble' games that selected from the Wii Fit Plus balance games section
Balance Trainer Balance ExercisesOther
Balance Trainer' training protocol consisted of 'Collect Apples', 'Outline', 'Paddle War' and 'Evaluation of Movement' games which were included in the device software and allowed the patients to done balance exercises in different directions.
| Study group | Role | What they receive |
|---|---|---|
| Nintendo Wii Fit | Experimental | Participants in the Nintendo Wii group were included to exercise program that consisted of 16 individual PT-supervised sessions (two 60-minute sessions/week), which were prepared to improve balance. Each session started with 10 minutes of non-resistance cycling work for warm-up. Receives: Other: Nintendo Wii Fit Balance exercises |
| Balance Trainer | Experimental | Participants in the Balance Trainer group were included to exercise program that consisted of 16 individual PT-supervised sessions (two 60-minute sessions/week), which were prepared to improve balance. Each session started with 10 minutes of non-resistance cycling work for warm-up. Receives: Other: Balance Trainer Balance Exercises |
| Control | No intervention | Patients in the 'Group III-control group' were included in the waiting list until the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
The Berg Balance Scale is a 56-point scale designed to measure balance among older people by the assessment of functional tasks. Its concurrent validity has been established for people with multiple sclerosis. The Berg Balance Scale is a five point ordinal scale and consisting of 14 balance activity. Each activity is scored between 0-4 and higher total scores indicating less impaired balance. 45-56=independent, 21-44=assisted walking, 0-20=dependent.
Measured: Change between baseline and after 8 weeks of intervention were assessed.
Secondary outcomes (3)
Timed Up and Go Test
The patient's mobility requiring both static and dynamic balance was assessed by Timed up and go test which measures the time taken in seconds to arise from a standard chair, walk 3 m, turn through 180 degrees, walk back, and sit down again. A longer completion time indicates a higher risk of falling.
Measured: Change between baseline and after 8 weeks of intervention were assessed.
Six Minutes Walk Test
Patients were instructed to walk a 30 m corridor for 6 minutes and the distance completed after 6 minutes (6MWD) was recorded.
Measured: Change between baseline and after 8 weeks of intervention were assessed.
Fatigue Severity Scale
Fatigue severity scale is a nine-item, self-administered questionnaire that assesses the fatigue level in daily functions of MS patients. The items are scored on a 7 point scale with 1=strongly disagree and 7=strongly agree. The minimum score=9 and maximum score=63. Higher fatigue severity scale scores indicating greater severity of fatigue.
Measured: Change between baseline and after 8 weeks of intervention were assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start15 Jul 2016
- Primary completion15 Jul 2017
- Study completion15 Jul 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Principal investigator, Yonca Zenginler, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436927
- Sponsor's protocol ID
- YZenginler
- Status last verified
- Feb 2018
- First submitted
- 11 Dec 2017
- Last updated
- 19 Feb 2018
- 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 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Two Different Virtual Reality Treatment Methods in Patients With Multiple Sclerosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03436927
- Acronym / sponsor ID
- YZenginler
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, rehabilitation, postural balance, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 15 Jul 2017 (actual)
- Study completion
- 15 Jul 2017 (actual)
- First posted
- 19 Feb 2018 (actual)
- 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.
As a chronic, autoimmune, inflammatory disease of the central nervous system, Multiple Sclerosis (MS) is a neurologic problem which the most frequent cause of disability in young adults. Fatigue, pain, spasticity, muscle weakness, depression, as well as balance and gait disorders are amongst the symptoms of MS. Balance disorders and the falls caused by them are the most frequent problems which result in disability of MS patients, with 75% of all patients being affected during the course of disease. When considering previous studies carried out on physiotherapy and rehabilitation practices in the light of balance disorders and other related problems faced by MS patients, it can been that various physiotherapeutic approaches are applied with varying follow-up times and in the form of hospital sessions, home sessions, or group training. Posture and balance problems in MS patients are tried to be solved through long-lasting treatment sessions using traditional methods of physiotherapy, where less patient participation is observed. Fatigue, psychological impairment, and insufficient motivation are other aspects which influence the success of treatment and which need to be addressed in MS patients. In contrast to traditional methods of physiotherapy applied in form of long-lasting treatment sessions, technology-supported rehabilitation approaches have emerged in recent years. It can be seen that different systems have started to be employed in the physiotherapy of many chronic diseases, either alone or in company with traditional methods. Even though the clinical use of these systems is becoming widespread, there are certain gaps in terms of the systems' impacts, comparative advantages, or cost effectiveness. Keeping this in mind, the purpose of this study is to investigate and compare the impacts of 'Nintendo Wii Fit' and 'Balance Trainer', as two of the technologic methods with therapeutic impact which have started to be used for different diagnosis groups in recent years, on the balance and posture parameters of MS patients, with the ultimate aim to introduce a whole new point of view to traditional physiotherapy and rehabilitation studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nintendo Wii Fit | Experimental | Other: Nintendo Wii Fit Balance exercisesParticipants in the Nintendo Wii group were included to exercise program that consisted of 16 individual PT-supervised sessions (two 60-minute sessions/week), which were prepared to improve balance. Each session started with 10 minutes of non-resistance cycling work for warm-up. |
| Balance Trainer | Experimental | Other: Balance Trainer Balance ExercisesParticipants in the Balance Trainer group were included to exercise program that consisted of 16 individual PT-supervised sessions (two 60-minute sessions/week), which were prepared to improve balance. Each session started with 10 minutes of non-resistance cycling work for warm-up. |
| Control | No intervention | –Patients in the 'Group III-control group' were included in the waiting list until the end of the study. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- . Participants who were ambulatory and volunteer to participate to the study, in a stable phase of the disease, without relapses or worsening in the last 3 months, with an EDSS between 2.5-6 and aged between 25 to 60 years
Key exclusion criteria (1 listed)
- physical activity more than 150 minutes per week, were pregnant, had blurred vision, had psychiatric problems, or severe cognitive impairment.
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 |
|---|---|---|
| Nintendo Wii Fit Balance exercisesNintendo Wii Fit' training protocol consisted of 'Penguin Slide', 'Table Tilt', 'Ski Slalom', 'Heading' and 'Balance Bubble' games that selected from the Wii Fit Plus balance games section | Other | Nintendo Wii Fit |
| Balance Trainer Balance ExercisesBalance Trainer' training protocol consisted of 'Collect Apples', 'Outline', 'Paddle War' and 'Evaluation of Movement' games which were included in the device software and allowed the patients to done balance exercises in different directions. | Other | Balance Trainer |
Primary outcome
Berg Balance Scale
Time frame: Change between baseline and after 8 weeks of intervention were assessed.
The Berg Balance Scale is a 56-point scale designed to measure balance among older people by the assessment of functional tasks. Its concurrent validity has been established for people with multiple sclerosis. The Berg Balance Scale is a five point ordinal scale and consisting of 14 balance activity. Each activity is scored between 0-4 and higher total scores indicating less impaired balance. 45-56=independent, 21-44=assisted walking, 0-20=dependent.
3 secondary outcomes
Timed Up and Go Test
Time frame: Change between baseline and after 8 weeks of intervention were assessed.
Six Minutes Walk Test
Time frame: Change between baseline and after 8 weeks of intervention were assessed.
Fatigue Severity Scale
Time frame: Change between baseline and after 8 weeks of intervention were assessed.
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 19 Feb 2018.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Nintendo Wii Fit Balance exercises and Balance Trainer Balance Exercises in people with Multiple Sclerosis, run by Biruni University.
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 1 inclusion and 1 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 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Berg Balance Scale (time frame: Change between baseline and after 8 weeks of intervention were assessed.). 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 19 Feb 2018.