- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Ohio
-
Columbus, Ohio, Spojené státy, 43210
- The Ohio State University Atwell Hall
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Dance Dance Revolution game play
Dance Dance Revolution video game play
|
Individuals play dance dance revolution 3 times a week for 8 weeks
|
Žádný zásah: control
individuals continue usual care for 8 weeks
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Berg Balance Scale
Časové okno: 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
Časové okno: after 8 weeks
|
The PASAT is a measure of sustained attention, working memory and information processing speed.
|
after 8 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
4 square step test
Časové okno: 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
Časové okno: after 8 weeks
|
Measures fear of falling.
Subjects rate their balance confidence on 10 items.
|
after 8 weeks
|
GAITRite
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: after 8 weeks
|
individuals will go into an MRI and undergo neuropsychological and motor testing to examine for neuroplasticity
|
after 8 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Ruchika Prakash, PhD, Ohio State University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2011H0048
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