- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07720427
COMPARING EFFECTS OF NINTENDO EXERGAMING TO A NO INTERVENTION CONTROL GROUP
Exergaming Intervention Study
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Parents of each ASD participant completed a screening form and the parent and participant completed an additional screening interview before participating in a pretest visit to confirm study eligibility.
After the motor and cognitive pretests and parent questionnaires were completed and eligibility was confirmed, each participant was randomly assigned to the Nintendo exergaming (NE) intervention or no intervention control group.
Each participant in the NE group received 8 weeks of exergaming intervention for 45-60 minutes per session @2 sessions per week. After the intervention period was completed motor and cognitive posttests and parent questionnaires were completed to assess preliminary outcomes.
We also completed feasibility and acceptability measures using parent, trainer, and child surveys.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Delaware
-
Newark, Delaware, Forente stater, 19060
- Health Sciences Campus, University of Delaware
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- A school or medical record of holding an autism diagnosis
Exclusion Criteria:
- Did not follow 1 to 2-step instructions at the pretest.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Nintendo Switch Exergaming
This group received 8 weeks of Nintendo Switch Exergaming Intervention @ 2 days per week for 45-60 minutes per session.
Pretests and posttests were completed before and after this period.
|
Each exergaming intervention session included RingFit warm-up, RingFit Adventure Games to target multiple motor domains including body coordination, strength, and endurance and the Nintendo Switch Sports virtual sports targeted body coordination and visuomotor skills.
|
|
Ingen inngripen: No Intervention Control Group
This group received 8 weeks of business as usual control period.
Pretests and posttests were completed before and after this period.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Bruininks Oseretsky Test of Motor Performance
Tidsramme: Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
The BOT-2 is a standardized motor test that is a reliable and valid motor measure for youth between the ages of 4 to 21 years (Bruininks & Bruininks, 2005).
Participants' gross motor skills were assessed using the balance (BAL), bilateral coordination (BLC), strength (STN), and agility (AGIL) subtests of BOT-2.
Subtests are combined to provide a body coordination (BC, includes BAL and BLC), strength/agility (SA, includes STR and AGIL) and manual coordination (MC, includes MD and ULC) composite standard score at pretest and posttest.
Change in composite standard scores (BC, SA, and MC) were assessed between pretest and posttest performance.
|
Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Bilateral Motor Coordination Subtest of there Sensory Integration and Praxis Test (SIPT-BMC) Battery
Tidsramme: Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
The SIPT BMC subtest assesses a youth's ability to imitate 22 novel hand and feet rhythmic actions shown by the tester.
During the test, the tester asks the child to repeat bilateral rhythmic sequences of the hands or feet.
An error occurrs if the youth does correctly imitate the sequence or rhythm of the tester's movements.
A spatial error was scored if the youth's scale or pattern of movement differed from that of the tester.
A temporal error occurred if the youth paused during the motor sequence, or moved slow/fast compared to tester.
Total spatial and temporal errors were calculated across all imitated actions at pretest and posttest.
|
Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
|
Developmental Coordination Disorder Questionnaire (DCD-Q)
Tidsramme: Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
Parents completed the 15-item motor screening tool to report their child's fine- motor, gross-motor, and general coordination abilities compared to their peers.
The total score at pretest and posttest were compared.
|
Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
|
Behavior Rating Inventory of Executive Function (BRIEF)
Tidsramme: Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
Parents completed the BRIEF to assess the youth's executive functioning skills during everyday tasks.
The total score at pretest and posttest was compared.
|
Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
|
Computerized Modified Flanker Task
Tidsramme: Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
All participants completed the Modified Flanker Task to assess the inhibitory control component of executive functioning.
The task consisted of four experimental blocks, with incongruent and congruent conditions presented in random order within each block of 30 trials, with 15 incongruent and 15 congruent trials.
a) Congruent: Five fish facing in the same direction, b) Incongruent: The outer four fish faced the same direction while the center fish faced the opposite direction.
Participants were instructed to click the arrow button on the screen to indicate the direction of the center fish and to respond as quickly and accurately as possible.
We compared the average reaction time at pretest and posttest.
|
Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
|
Computerized Modified Stroop Word-Color Task
Tidsramme: Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
The Stroop Task assessed the task switching, flexibility, and response inhibition components of executive functioning.
The task consisted of two conditions: Color and Word.
Participants were instructed to press the button on the screen to match the color of the letters shown in the color condition, or to match the spelling of the word shown in the Word condition.
Each block consisted of 40 trials.
Average reaction times at pretest and posttest were compared.
|
Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1947455
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Nintendo Switch Exergaming
-
Hitit UniversityFullførtMotorisk læring | Virtual Reality-basert terapi | Smidighet | Ankel dorsalfleksjonTyrkia (Türkiye)
-
Universidad Rey Juan CarlosFullførtEldre mennesker | Kognitiv svikt | Sunn aldring | ErgoterapiSpania
-
Cairo UniversityHar ikke rekruttert ennå
-
Universidad Rey Juan CarlosRekrutteringErvervet hjerneskade | Ergoterapi | VoksneSpania
-
Universidad de AlmeriaEuropean Union; Ministerio de Ciencia e Innovación, SpainRekruttering
-
Indiana UniversityFullførtAutismespektrumforstyrrelseForente stater
-
University of LiegeFonds National de la Recherche ScientifiqueFullførtSchizofreni | Bipolar lidelse | Major depressiv lidelse | Schizo affektiv lidelseBelgia
-
Riphah International UniversityRekruttering
-
Federal University of BahiaFullførtParkinsons sykdomBrasil
-
VA Connecticut Healthcare SystemFullførtDepresjon | PTSD | Schizofreni | Bipolar lidelse | Mentalt sykForente stater