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COMPARING EFFECTS OF NINTENDO EXERGAMING TO A NO INTERVENTION CONTROL GROUP

17 de julho de 2026 atualizado por: Anjana Bhat, University of Delaware

Exergaming Intervention Study

This is a pilot randomized clinical trial to evaluate the feasibility and acceptability, and preliminary outcomes of delivering a Nintendo Switch exergaming (NE group) intervention in a group of autistic youth with autism spectrum disorder (ASD) between 5 and 30 years compared to an age-matched, no intervention control group of autistic youth (Control group) .

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

30

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Delaware
      • Newark, Delaware, Estados Unidos, 19060
        • Health Sciences Campus, University of Delaware

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comportamental: Nintendo Switch Exergaming
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.
Sem intervenção: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Bruininks Oseretsky Test of Motor Performance
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Bilateral Motor Coordination Subtest of there Sensory Integration and Praxis Test (SIPT-BMC) Battery
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Delaware

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

2 de maio de 2023

Conclusão Primária (Real)

26 de março de 2024

Conclusão do estudo (Real)

26 de março de 2024

Datas de inscrição no estudo

Enviado pela primeira vez

17 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de julho de 2026

Primeira postagem (Real)

22 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 1947455

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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