Clinical trial NCT01780792: Examining the Effects of Video-game Exercise on Mobility and Brain Plasticity in Individuals With Multiple Sclerosis
Official title: Examining the Effects of Dance, Dance Revolution on Mobility, Brain Plasticity and Cognition in Individuals With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
mobility
cognition
neuroplasticity
videogame play
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2013-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Expanded Disability Status Score of \< 5 and a diagnosis of relapsing-remitting multiple sclerosis

Exclusion Criteria:

* other neurological or orthopedic diagnosis that limits ambulation, age 30-59

Primary outcomes:
measure: Berg Balance Scale
timeFrame: after 8 weeks
measure: PASAT
timeFrame: after 8 weeks
Secondary outcomes:
measure: 4 square step test
timeFrame: after 8 weeks
measure: The Activities Specific Balance Confidence Scale
timeFrame: after 8 weeks
measure: GAITRite
timeFrame: after 8 weeks
measure: 6 minute walk test
timeFrame: Immediately prior to starting the intervention/control period,, after 8 week intervention/control period and then at an 8 week follow up
measure: physical activity
timeFrame: after 8 weeks
measure: multiple sclerosis quality of life inventory
timeFrame: after 8 weeks
measure: fMRI
timeFrame: after 8 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Atwell Hall
state: Ohio
Study officials:
affiliation: Ohio State University
name: Deb Kegelmeyer, DPT, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Ruchika Prakash, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Anne Kloos, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: