Examining the Effects of Video-game Exercise on Mobility and Brain Plasticity in Individuals With Multiple Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Ruchika Prakash, Ohio State University
ClinicalTrials.gov Identifier:
NCT01780792
First received: November 7, 2012
Last updated: October 14, 2014
Last verified: October 2014

November 7, 2012
October 14, 2014
August 2011
August 2015   (final data collection date for primary outcome measure)
  • Berg Balance Scale [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The PASAT is a measure of sustained attention, working memory and information processing speed.
  • Berg Balance Scale [ Time Frame: Immediately prior to starting the intervention/control period,, after 8 week intervention/control period, and then at an 8 week follow up ] [ Designated as safety issue: No ]
    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: Immediately prior to starting the intervention/control period,, after 8 week intervention/control period ] [ Designated as safety issue: No ]
    The PASAT is a measure of sustained attention, working memory and information processing speed.
Complete list of historical versions of study NCT01780792 on ClinicalTrials.gov Archive Site
  • 4 square step test [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
    requires a person to step rapidly in a multi-directional pattern over a cane. It predicts fallers
  • The Activities Specific Balance Confidence Scale [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
    Measures fear of falling. Subjects rate their balance confidence on 10 items.
  • GAITRite [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
    individuals walk on a computerized carpet that records spatiotemporal aspects of gait such as velocity and stride length.
  • 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 ] [ Designated as safety issue: No ]
    subjects walk for 6 minutes and distance walked is measured
  • physical activity [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
    subjects wear an accelerometer for 5 days which records how active they are.
  • multiple sclerosis quality of life inventory [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
    the MS quality of life inventory is filled out to measure the impact of MS on the individuals quality of life.
  • fMRI [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
    individuals will go into an MRI and undergo neuropsychological and motor testing to examine for neuroplasticity
  • 4 square step 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 ] [ Designated as safety issue: No ]
    requires a person to step rapidly in a multi-directional pattern over a cane. It predicts fallers
  • The Activities Specific Balance Confidence Scale [ Time Frame: Immediately prior to starting the intervention/control period,, after 8 week intervention/control period and then at an 8 week follow up ] [ Designated as safety issue: No ]
    Measures fear of falling. Subjects rate their balance confidence on 10 items.
  • GAITRite [ Time Frame: Immediately prior to starting the intervention/control period,, after 8 week intervention/control period and then at an 8 week follow up ] [ Designated as safety issue: No ]
    individuals walk on a computerized carpet that records spatiotemporal aspects of gait such as velocity and stride length.
  • 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 ] [ Designated as safety issue: No ]
    subjects walk for 6 minutes and distance walked is measured
  • physical activity [ Time Frame: Immediately prior to starting the intervention/control period,, after 8 week intervention/control period ] [ Designated as safety issue: No ]
    subjects wear an accelerometer for 5 days which records how active they are.
  • multiple sclerosis quality of life inventory [ Time Frame: Immediately prior to starting the intervention/control period,, after 8 week intervention/control period ] [ Designated as safety issue: No ]
    the MS quality of life inventory is filled out to measure the impact of MS on the individuals quality of life.
  • fMRI [ Time Frame: Immediately prior to starting the intervention/control period,, after 8 week intervention/control period ] [ Designated as safety issue: No ]
    individuals will go into an MRI and undergo neuropsychological and motor testing to examine for neuroplasticity
Not Provided
Not Provided
 
Examining the Effects of Video-game Exercise on Mobility and Brain Plasticity in Individuals With Multiple Sclerosis
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Multiple Sclerosis
Other: Dance Dance Revolution video game play
Individuals play dance dance revolution 3 times a week for 8 weeks
  • Experimental: Dance Dance Revolution game play
    Dance Dance Revolution video game play
    Intervention: Other: Dance Dance Revolution video game play
  • No Intervention: control
    individuals continue usual care for 8 weeks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
34
December 2016
August 2015   (final data collection date for primary outcome measure)

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
Both
30 Years to 59 Years
No
Contact: Deb Kegelmeyer, DPT, MS 614-292-0610 kegelmeyer.1@osu.edu
United States
 
NCT01780792
2011H0048
No
Ruchika Prakash, Ohio State University
Ohio State University
Not Provided
Principal Investigator: Deb Kegelmeyer, DPT, MS Ohio State University
Principal Investigator: Ruchika Prakash, PhD Ohio State University
Principal Investigator: Anne Kloos, PT, PhD Ohio State University
Ohio State University
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP