Multiple SclerosisNCT01780792
Examining the Effects of Video-game Exercise on Mobility and Brain Plasticity in Individuals With Multiple Sclerosis
A study testing Dance Dance Revolution video game play in people with Multiple Sclerosis, run by Ohio State University at 1 site in United States.
Trial summary
Dance Dance Revolution (DDR) may offer an innovative and highly effective format for delivering exercise programs to people with multiple sclerosis (MS). It is a fun, engaging and interactive video game that requires players to move their feet to targets while matching the rhythm of a song. Read more about this study
- Who is it for?
- Ages 30 to 59 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Dance Dance Revolution video game play
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Dec 2016
- 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 30 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Expanded Disability Status Score of < 5 and a diagnosis of relapsing-remitting multiple sclerosis
Who cannot join
- other neurological or orthopedic diagnosis that limits ambulation, age 30-59
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Atwell Hall
Columbus, Ohio, 43210
About this study
Official title: Examining the Effects of Dance, Dance Revolution on Mobility, Brain Plasticity and Cognition in Individuals With Multiple Sclerosis
Dance Dance Revolution (DDR) may offer an innovative and highly effective format for delivering exercise programs to people with multiple sclerosis (MS). It is a fun, engaging and interactive video game that requires players to move their feet to targets while matching the rhythm of a song. In addition, DDR, involving both aerobic exercise and cognitive training, is an ideal intervention for improving cognitive functioning in those with MS. The purpose of this pilot study is to examine the use of DDR as a novel and highly specific exercise intervention to improve mobility and cognition among individuals with MS.
Read the detailed description
Dance Dance Revolution (DDR) may offer an innovative and highly effective format for delivering exercise programs to people with MS. It is a fun, engaging and interactive video game that requires players to move their feet to targets while matching the rhythm of a song. In addition, DDR, involving both aerobic exercise and cognitive training, is an ideal intervention for improving cognitive functioning in those with MS. The purpose of this pilot study is to examine the use of DDR as a novel and highly specific exercise intervention to improve mobility and cognition among individuals with MS. We will be guided by the following three specific aims and hypotheses:
Specific Aim 1: Determine if an eight-week exercise program administered using DDR improves dynamic balance in people with MS relative to a wait-list control group.
Hypothesis 1: Dynamic balance as measured by the Berg Balance Scale will be more improved with the DDR intervention than the wait-list control group.
Specific Aim 2: Determine if the DDR intervention, combining fitness and cognitive training, over the course of an eight-week intervention, will have a more positive effect on domains of processing speed and executive control, than a wait-list control group.
Hypothesis 2: The DDR group relative to the wait-list control group, will show significant improvement in cognitive functioning as assessed by the Paced Auditory Serial Addition Test (PASAT), a measure of processing speed, and executive functioning. Specifically, we hypothesize that given severe deficits in processing speed and executive control, participation in a DDR intervention, will result in a significant improvement on the PASAT, a widely used measure to assess cognitive functioning in patients with MS.
Specific Aim 3: We will also examine whether improvements in cognitive processes engendered by DDR on the PASAT will be supported by changes in underlying neural circuits, as inferred from patterns of event-related functional magnetic resonance imaging (fMRI) activation obtained in a 3 Tesla scanner.
Hypothesis 3: Improvements in cognition as indexed by higher accuracy scores and faster reaction time on the PASAT, will be accompanied by a change in the recruitment of underlying neural processes as inferred from functional magnetic resonance imaging. MS participants in the DDR group will show an increase in recruitment of the attentional network, and more specifically the prefrontal and parietal cortices, cortical regions responsible for successful performance on the PASAT task.
- Conditions
- Multiple Sclerosis
- Being tested
- Dance Dance Revolution video game play
- Keywords
- multiple sclerosis, mobility, cognition, neuroplasticity, videogame play
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance Dance Revolution video game playOther
Individuals play dance dance revolution 3 times a week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dance Dance Revolution game play | Experimental | Dance Dance Revolution video game play Receives: Other: Dance Dance Revolution video game play |
| control | No intervention | individuals continue usual care for 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
The Berg Balance scale consists of 14 functional activities that test static and dynamic balance. Each item is scored on a scale of 0-4 with higher scores indicating better balance
Measured: after 8 weeks
PASAT
The PASAT is a measure of sustained attention, working memory and information processing speed.
Measured: after 8 weeks
Secondary outcomes (7)
4 square step test
requires a person to step rapidly in a multi-directional pattern over a cane. It predicts fallers
Measured: after 8 weeks
The Activities Specific Balance Confidence Scale
Measures fear of falling. Subjects rate their balance confidence on 10 items.
Measured: after 8 weeks
GAITRite
individuals walk on a computerized carpet that records spatiotemporal aspects of gait such as velocity and stride length.
Measured: after 8 weeks
6 minute walk test
subjects walk for 6 minutes and distance walked is measured
Measured: Immediately prior to starting the intervention/control period,, after 8 week intervention/control period and then at an 8 week follow up
physical activity
subjects wear an accelerometer for 5 days which records how active they are.
Measured: after 8 weeks
multiple sclerosis quality of life inventory
the MS quality of life inventory is filled out to measure the impact of MS on the individuals quality of life.
Measured: after 8 weeks
fMRI
individuals will go into an MRI and undergo neuropsychological and motor testing to examine for neuroplasticity
Measured: after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startAug 2011
- Primary completionAug 2015
- Study completionDec 2016
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.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruchika Prakash, Ohio State University
- Investigators
- Deb Kegelmeyer, DPT, MS, Principal investigator, Ohio State UniversityRuchika Prakash, PhD, Principal investigator, Ohio State UniversityAnne Kloos, PT, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780792
- Sponsor's protocol ID
- 2011H0048
- Status last verified
- Apr 2017
- First submitted
- 7 Nov 2012
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Dance, Dance Revolution on Mobility, Brain Plasticity and Cognition in Individuals With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01780792
- Acronym / sponsor ID
- 2011H0048
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, mobility, cognition, neuroplasticity, videogame play
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 31 Jan 2013 (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.
Dance Dance Revolution (DDR) may offer an innovative and highly effective format for delivering exercise programs to people with multiple sclerosis (MS). It is a fun, engaging and interactive video game that requires players to move their feet to targets while matching the rhythm of a song. In addition, DDR, involving both aerobic exercise and cognitive training, is an ideal intervention for improving cognitive functioning in those with MS. The purpose of this pilot study is to examine the use of DDR as a novel and highly specific exercise intervention to improve mobility and cognition among individuals with MS.
Detailed description
Dance Dance Revolution (DDR) may offer an innovative and highly effective format for delivering exercise programs to people with MS. It is a fun, engaging and interactive video game that requires players to move their feet to targets while matching the rhythm of a song. In addition, DDR, involving both aerobic exercise and cognitive training, is an ideal intervention for improving cognitive functioning in those with MS. The purpose of this pilot study is to examine the use of DDR as a novel and highly specific exercise intervention to improve mobility and cognition among individuals with MS. We will be guided by the following three specific aims and hypotheses:
Specific Aim 1: Determine if an eight-week exercise program administered using DDR improves dynamic balance in people with MS relative to a wait-list control group.
Hypothesis 1: Dynamic balance as measured by the Berg Balance Scale will be more improved with the DDR intervention than the wait-list control group.
Specific Aim 2: Determine if the DDR intervention, combining fitness and cognitive training, over the course of an eight-week intervention, will have a more positive effect on domains of processing speed and executive control, than a wait-list control group.
Hypothesis 2: The DDR group relative to the wait-list control group, will show significant improvement in cognitive functioning as assessed by the Paced Auditory Serial Addition Test (PASAT), a measure of processing speed, and executive functioning. Specifically, we hypothesize that given severe deficits in processing speed and executive control, participation in a DDR intervention, will result in a significant improvement on the PASAT, a widely used measure to assess cognitive functioning in patients with MS.
Specific Aim 3: We will also examine whether improvements in cognitive processes engendered by DDR on the PASAT will be supported by changes in underlying neural circuits, as inferred from patterns of event-related functional magnetic resonance imaging (fMRI) activation obtained in a 3 Tesla scanner.
Hypothesis 3: Improvements in cognition as indexed by higher accuracy scores and faster reaction time on the PASAT, will be accompanied by a change in the recruitment of underlying neural processes as inferred from functional magnetic resonance imaging. MS participants in the DDR group will show an increase in recruitment of the attentional network, and more specifically the prefrontal and parietal cortices, cortical regions responsible for successful performance on the PASAT task.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dance Dance Revolution game play | Experimental | Other: Dance Dance Revolution video game playDance Dance Revolution video game play |
| control | No intervention | –individuals continue usual care for 8 weeks |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Expanded Disability Status Score of < 5 and a diagnosis of relapsing-remitting multiple sclerosis
Key exclusion criteria (1 listed)
- other neurological or orthopedic diagnosis that limits ambulation, age 30-59
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 |
|---|---|---|
| Dance Dance Revolution video game playIndividuals play dance dance revolution 3 times a week for 8 weeks | Other | Dance Dance Revolution game play |
Primary outcome
Berg Balance Scale
Time frame: after 8 weeks
The Berg Balance scale consists of 14 functional activities that test static and dynamic balance. Each item is scored on a scale of 0-4 with higher scores indicating better balance
PASAT
Time frame: after 8 weeks
The PASAT is a measure of sustained attention, working memory and information processing speed.
7 secondary outcomes
4 square step test
Time frame: after 8 weeks
The Activities Specific Balance Confidence Scale
Time frame: after 8 weeks
GAITRite
Time frame: after 8 weeks
6 minute walk test
Time frame: Immediately prior to starting the intervention/control period,, after 8 week intervention/control period and then at an 8 week follow up
physical activity
Time frame: after 8 weeks
multiple sclerosis quality of life inventory
Time frame: after 8 weeks
fMRI
Time frame: after 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 7 Apr 2017.
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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.
Deb Kegelmeyer, DPT, MS principal investigator
Ohio State University
Ruchika Prakash, PhD principal investigator
Ohio State University
Anne Kloos, PT, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance Dance Revolution video game play in people with Multiple Sclerosis, run by Ohio State University at 1 site in United States.
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 7 Apr 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 United States. 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?
Berg Balance Scale (time frame: after 8 weeks). The study lists 2 primary outcomes in all. 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 7 Apr 2017.