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COMPARING EFFECTS OF NINTENDO EXERGAMING TO A NO INTERVENTION CONTROL GROUP

17 de julio de 2026 actualizado 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) .

Descripción general del estudio

Descripción detallada

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 estudio

Intervencionista

Inscripción (Actual)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
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.
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Bruininks Oseretsky Test of Motor Performance
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Bilateral Motor Coordination Subtest of there Sensory Integration and Praxis Test (SIPT-BMC) Battery
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

2 de mayo de 2023

Finalización primaria (Actual)

26 de marzo de 2024

Finalización del estudio (Actual)

26 de marzo de 2024

Fechas de registro del estudio

Enviado por primera vez

17 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de julio de 2026

Publicado por primera vez (Actual)

22 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Nintendo Switch Exergaming

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