- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Ohio
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Columbus, Ohio, Stati Uniti, 43210
- The Ohio State University Atwell Hall
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Dance Dance Revolution game play
Dance Dance Revolution video game play
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Individuals play dance dance revolution 3 times a week for 8 weeks
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Nessun intervento: control
individuals continue usual care for 8 weeks
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Berg Balance Scale
Lasso di tempo: after 8 weeks
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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
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after 8 weeks
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PASAT
Lasso di tempo: after 8 weeks
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The PASAT is a measure of sustained attention, working memory and information processing speed.
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after 8 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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4 square step test
Lasso di tempo: after 8 weeks
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requires a person to step rapidly in a multi-directional pattern over a cane.
It predicts fallers
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after 8 weeks
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The Activities Specific Balance Confidence Scale
Lasso di tempo: after 8 weeks
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Measures fear of falling.
Subjects rate their balance confidence on 10 items.
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after 8 weeks
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GAITRite
Lasso di tempo: after 8 weeks
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individuals walk on a computerized carpet that records spatiotemporal aspects of gait such as velocity and stride length.
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after 8 weeks
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6 minute walk test
Lasso di tempo: Immediately prior to starting the intervention/control period,, after 8 week intervention/control period and then at an 8 week follow up
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subjects walk for 6 minutes and distance walked is measured
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Immediately prior to starting the intervention/control period,, after 8 week intervention/control period and then at an 8 week follow up
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physical activity
Lasso di tempo: after 8 weeks
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subjects wear an accelerometer for 5 days which records how active they are.
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after 8 weeks
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multiple sclerosis quality of life inventory
Lasso di tempo: after 8 weeks
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the MS quality of life inventory is filled out to measure the impact of MS on the individuals quality of life.
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after 8 weeks
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fMRI
Lasso di tempo: after 8 weeks
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individuals will go into an MRI and undergo neuropsychological and motor testing to examine for neuroplasticity
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after 8 weeks
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Ruchika Prakash, PhD, Ohio State University
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2011H0048
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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