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NCT06023563

Effect of Virtual Reality-based Training on Balance and Walking in Youth With Autism Spectrum Disorder

Completed NA Results posted Last updated 12 August 2025
What this trial tests

NA trial testing Virtual reality active video gaming using Nintendo switch sports in Autism Spectrum Disorder in 13 participants. Completed in 19 April 2024.

Timeline
15 May 2023
Primary endpoint
19 April 2024
19 April 2024

Quick facts

Lead sponsorIndiana University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment13
Start date15 May 2023
Primary completion19 April 2024
Estimated completion19 April 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Indiana University

Who can join

Adults 7 to 22, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in the Center of Pressure Movement (Postural Sway Velocity) Primary · 5 days before the intervention, 5 days after the intervention and 4 weeks after the intervention

High resolution pressure mat containing multiple integrated sensors is used to detect center of pressure movement of the person standing on it recorded at 100 Hz

baseline
GroupValue95% CI
Virtual Reality Active Video Gaming0.93± 1.02
Standard Balance Exercises0.50± 0.30
post-1
GroupValue95% CI
Virtual Reality Active Video Gaming1± 1.1
Standard Balance Exercises0.8± 0.69
post-2
GroupValue95% CI
Virtual Reality Active Video Gaming1.4± 2.1
Standard Balance Exercises0.74± 0.63
Change in Pediatric Berg's Balance Scale Score Primary · 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention

Pediatric Berg's balance Scale: 14-component battery that evaluates daily living tasks such as sitting to standing, transferring from one chair to another, and sitting and standing without support. This scale is reliable and valid clinical balance assessment tool for children and youth with motor impairments. Maximum total score is 56 points and minimum total score is 0 points. Higher score indicates better balance such that increase in total score by 3.7 points indicates minimal clinically important difference.

baseline
GroupValue95% CI
Virtual Reality Active Video Gaming51.86± 2.91
Standard Balance Exercises52.00± 2.00
post-1
GroupValue95% CI
Virtual Reality Active Video Gaming55.43± 1.13
Standard Balance Exercises55± 1.26
post-2
GroupValue95% CI
Virtual Reality Active Video Gaming55.14± 1.21
Standard Balance Exercises54.67± 1.21
Change in Step Length (Meters) of the Gait Primary · 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention

13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: step length (meters).

Baseline
GroupValue95% CI
Virtual Reality Active Video Gaming0.69± 0.07
Standard Balance Exercises0.71± 0.03
post-1
GroupValue95% CI
Virtual Reality Active Video Gaming0.68± 0.12
Standard Balance Exercises0.66± 0.06
post-2
GroupValue95% CI
Virtual Reality Active Video Gaming0.71± 0.06
Standard Balance Exercises0.70± 0.07
Change in Stride Width (Meters) of the Gait Primary · 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention

13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: step width (meters).

Baseline
GroupValue95% CI
Virtual Reality Active Video Gaming0.11± 0.03
Standard Balance Exercises0.11± 0.03
post-1
GroupValue95% CI
Virtual Reality Active Video Gaming0.11± 0.03
Standard Balance Exercises0.11± 0.02
post-2
GroupValue95% CI
Virtual Reality Active Video Gaming0.12± 0.03
Standard Balance Exercises0.11± 0.02
Change in Stride Length (Meters) of the Gait Primary · 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention

13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: stride length (meters).

Baseline
GroupValue95% CI
Virtual Reality Active Video Gaming1.33± 0.14
Standard Balance Exercises1.37± 0.05
post-1
GroupValue95% CI
Virtual Reality Active Video Gaming1.35± 0.14
Standard Balance Exercises1.31± 0.15
post-2
GroupValue95% CI
Virtual Reality Active Video Gaming1.37± 0.14
Standard Balance Exercises1.38± 0.14
Change in Double Support Period (Seconds) of the Gait Primary · 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention

13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: double support period (seconds).

Baseline
GroupValue95% CI
Virtual Reality Active Video Gaming0.12± 0.03
Standard Balance Exercises0.15± 0.03
post-1
GroupValue95% CI
Virtual Reality Active Video Gaming0.11± 0.02
Standard Balance Exercises0.17± 0.05
post-2
GroupValue95% CI
Virtual Reality Active Video Gaming0.12± 0.04
Standard Balance Exercises0.15± 0.03
Change in the Cadence (Steps/Minute) of the Gait Primary · 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention

13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: cadence (number of steps/minute).

baseline
GroupValue95% CI
Virtual Reality Active Video Gaming111.96± 9.89
Standard Balance Exercises110.31± 4.85
post-1
GroupValue95% CI
Virtual Reality Active Video Gaming114.70± 8.98
Standard Balance Exercises115.80± 14.97
post-2
GroupValue95% CI
Virtual Reality Active Video Gaming113.76± 6.52
Standard Balance Exercises113.71± 3.51
Change in Gait Velocity (Meters/Second) Primary · 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention

13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: gait velocity (meters/second).

baseline
GroupValue95% CI
Virtual Reality Active Video Gaming1.27± 0.21
Standard Balance Exercises1.25± 0.10
post-1
GroupValue95% CI
Virtual Reality Active Video Gaming1.30± 0.20
Standard Balance Exercises1.20± 0.12
post-2
GroupValue95% CI
Virtual Reality Active Video Gaming1.30± 0.18
Standard Balance Exercises1.29± 0.09

Sponsor's own description

The goal of this clinical trial is to assess the effect of short-term (3 days/week for 2 weeks) Virtual Reality (VR) active video gaming intervention on static and dynamic balance, versus traditional balance training exercises, in youth with ASD. The participants in the intervention group will engage in VR active video gaming using the Nintendo Switch Sports under supervision via Zoom for 6 sessions occurring over 2 weeks, from their home. While, the participants in the control group will engage in standard physical therapy exercises for balance and walking under supervision via Zoom, for 6 sessions occurring over 2 weeks, from their home. Their balance and walking will be assessed 3 times, 3-5 days before the intervention, 3-5 days after the intervention and 4-weeks after the intervention. * Participants static balance will be assessed by standing on pressure mat, under 2 conditions, eyes open and eyes closed for 30 seconds each. * The Pediatric Berg's balance Scale (PBS), a 14-point scale containing everyday activities, will be used as a clinical measure for assessing the static and dynamic balance. * 13-infra-red camera motion capture system, Qualisys, will be used for assessing the walking. The difference in the balance and walking parameters will be assessed and compared.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Autism Spectrum Disorder

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06023563.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing