COMPARING EFFECTS OF NINTENDO EXERGAMING TO A NO INTERVENTION CONTROL GROUP

July 17, 2026 updated by: 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) .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19060
        • Health Sciences Campus, University of Delaware

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bruininks Oseretsky Test of Motor Performance
Time Frame: 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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bilateral Motor Coordination Subtest of there Sensory Integration and Praxis Test (SIPT-BMC) Battery
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Delaware

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1947455

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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