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

5. april 2017 opdateret af: Ruchika Prakash, Ohio State University

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • The Ohio State University Atwell Hall

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år til 59 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dance Dance Revolution game play
Dance Dance Revolution video game play
Individuals play dance dance revolution 3 times a week for 8 weeks
Ingen indgriben: control
individuals continue usual care for 8 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Berg Balance Scale
Tidsramme: 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
after 8 weeks
PASAT
Tidsramme: after 8 weeks
The PASAT is a measure of sustained attention, working memory and information processing speed.
after 8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
4 square step test
Tidsramme: after 8 weeks
requires a person to step rapidly in a multi-directional pattern over a cane. It predicts fallers
after 8 weeks
The Activities Specific Balance Confidence Scale
Tidsramme: after 8 weeks
Measures fear of falling. Subjects rate their balance confidence on 10 items.
after 8 weeks
GAITRite
Tidsramme: after 8 weeks
individuals walk on a computerized carpet that records spatiotemporal aspects of gait such as velocity and stride length.
after 8 weeks
6 minute walk test
Tidsramme: Immediately prior to starting the intervention/control period,, after 8 week intervention/control period and then at an 8 week follow up
subjects walk for 6 minutes and distance walked is 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
Tidsramme: after 8 weeks
subjects wear an accelerometer for 5 days which records how active they are.
after 8 weeks
multiple sclerosis quality of life inventory
Tidsramme: after 8 weeks
the MS quality of life inventory is filled out to measure the impact of MS on the individuals quality of life.
after 8 weeks
fMRI
Tidsramme: after 8 weeks
individuals will go into an MRI and undergo neuropsychological and motor testing to examine for neuroplasticity
after 8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Ruchika Prakash, PhD, Ohio State University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2011

Primær færdiggørelse (Faktiske)

1. august 2015

Studieafslutning (Faktiske)

1. december 2016

Datoer for studieregistrering

Først indsendt

7. november 2012

Først indsendt, der opfyldte QC-kriterier

29. januar 2013

Først opslået (Skøn)

31. januar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. april 2017

Sidst verificeret

1. april 2017

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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