- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01780792
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Ohio
-
Columbus, Ohio, Förenta staterna, 43210
- The Ohio State University Atwell Hall
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Dance Dance Revolution game play
Dance Dance Revolution video game play
|
Individuals play dance dance revolution 3 times a week for 8 weeks
|
|
Inget ingripande: control
individuals continue usual care for 8 weeks
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Berg Balance Scale
Tidsram: 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
Tidsram: after 8 weeks
|
The PASAT is a measure of sustained attention, working memory and information processing speed.
|
after 8 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
4 square step test
Tidsram: 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
Tidsram: after 8 weeks
|
Measures fear of falling.
Subjects rate their balance confidence on 10 items.
|
after 8 weeks
|
|
GAITRite
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: after 8 weeks
|
individuals will go into an MRI and undergo neuropsychological and motor testing to examine for neuroplasticity
|
after 8 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Ruchika Prakash, PhD, Ohio State University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2011H0048
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .