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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dance Dance Revolution video game play
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, mobility, cognition, neuroplasticity, videogame play

Eligibility Criteria

30 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ohio State University Atwell Hall

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dance Dance Revolution game play

control

Arm Description

Dance Dance Revolution video game play

individuals continue usual care for 8 weeks

Outcomes

Primary Outcome Measures

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
PASAT
The PASAT is a measure of sustained attention, working memory and information processing speed.

Secondary Outcome Measures

4 square step test
requires a person to step rapidly in a multi-directional pattern over a cane. It predicts fallers
The Activities Specific Balance Confidence Scale
Measures fear of falling. Subjects rate their balance confidence on 10 items.
GAITRite
individuals walk on a computerized carpet that records spatiotemporal aspects of gait such as velocity and stride length.
6 minute walk test
subjects walk for 6 minutes and distance walked is measured
physical activity
subjects wear an accelerometer for 5 days which records how active they are.
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.
fMRI
individuals will go into an MRI and undergo neuropsychological and motor testing to examine for neuroplasticity

Full Information

First Posted
November 7, 2012
Last Updated
April 5, 2017
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT01780792
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, mobility, cognition, neuroplasticity, videogame play

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dance Dance Revolution game play
Arm Type
Experimental
Arm Description
Dance Dance Revolution video game play
Arm Title
control
Arm Type
No Intervention
Arm Description
individuals continue usual care for 8 weeks
Intervention Type
Other
Intervention Name(s)
Dance Dance Revolution video game play
Intervention Description
Individuals play dance dance revolution 3 times a week for 8 weeks
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
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
Time Frame
after 8 weeks
Title
PASAT
Description
The PASAT is a measure of sustained attention, working memory and information processing speed.
Time Frame
after 8 weeks
Secondary Outcome Measure Information:
Title
4 square step test
Description
requires a person to step rapidly in a multi-directional pattern over a cane. It predicts fallers
Time Frame
after 8 weeks
Title
The Activities Specific Balance Confidence Scale
Description
Measures fear of falling. Subjects rate their balance confidence on 10 items.
Time Frame
after 8 weeks
Title
GAITRite
Description
individuals walk on a computerized carpet that records spatiotemporal aspects of gait such as velocity and stride length.
Time Frame
after 8 weeks
Title
6 minute walk test
Description
subjects walk for 6 minutes and distance walked is measured
Time Frame
Immediately prior to starting the intervention/control period,, after 8 week intervention/control period and then at an 8 week follow up
Title
physical activity
Description
subjects wear an accelerometer for 5 days which records how active they are.
Time Frame
after 8 weeks
Title
multiple sclerosis quality of life inventory
Description
the MS quality of life inventory is filled out to measure the impact of MS on the individuals quality of life.
Time Frame
after 8 weeks
Title
fMRI
Description
individuals will go into an MRI and undergo neuropsychological and motor testing to examine for neuroplasticity
Time Frame
after 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deb Kegelmeyer, DPT, MS
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ruchika Prakash, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne Kloos, PT, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Atwell Hall
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

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

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