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
  Purpose

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.


Condition Intervention
Multiple Sclerosis
Other: Dance Dance Revolution video game play

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Examining the Effects of Dance, Dance Revolution on Mobility, Brain Plasticity and Cognition in Individuals With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 34
Study Start Date: August 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dance Dance Revolution game play
Dance Dance Revolution video game play
Other: Dance Dance Revolution video game play
Individuals play dance dance revolution 3 times a week for 8 weeks
No Intervention: control
individuals continue usual care for 8 weeks

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

Ages Eligible for Study:   30 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780792

Contacts
Contact: Deb Kegelmeyer, DPT, MS 614-292-0610 kegelmeyer.1@osu.edu

Locations
United States, Ohio
The Ohio State University Atwell Hall Recruiting
Columbus, Ohio, United States, 43210
Contact: Deb Kegelmeyer, DPT, MS    614-292-0610    kegelmeyer.1@osu.edu   
Principal Investigator: Ruchika Prakash, PhD         
Principal Investigator: Anne Kloos, PT, PhD         
Principal Investigator: Deb Kegelmeyer, DPT, MS         
Principal Investigator: Deborah Larsen, PT, PhD         
Sponsors and Collaborators
Ohio State University
Investigators
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
  More Information

No publications provided

Responsible Party: Ruchika Prakash, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01780792     History of Changes
Other Study ID Numbers: 2011H0048
Study First Received: November 7, 2012
Last Updated: October 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
multiple sclerosis
mobility
cognition
neuroplasticity
videogame play

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014