- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07720427
COMPARING EFFECTS OF NINTENDO EXERGAMING TO A NO INTERVENTION CONTROL GROUP
Exergaming Intervention Study
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Delaware
-
Newark, Delaware, United States, 19060
- Health Sciences Campus, University of Delaware
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
|
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
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1947455
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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