Autism Spectrum DisorderNCT06023563
Effect of Virtual Reality-based Training on Balance and Walking in Youth With Autism Spectrum Disorder
A study testing Virtual reality active video gaming using Nintendo switch sports and Standard physical therapy balance exercises in people with Autism Spectrum Disorder, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 22 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Virtual reality active video gaming using Nintendo switch sports and Standard physical therapy balance exercises
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2023to 19 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 7-22 years,
- existing ASD DSM-5 level 1 or 2 diagnosis confirmed by medical record/ educational services categorized under ASD/ therapeutic services categorized under ASD/ any other official document indicating the diagnosis of ASD,
- able to follow instructions and
- able to stand unsupported for at least 20 minutes.
Who cannot join
- epilepsy or other medical conditions which can be exacerbated by looking at a screen,
- Uncorrected vision loss or any other eye condition prohibiting looking at the screen for a prolong time,
- co-occurring musculoskeletal conditions such as joint or muscle pain or stiffness that limits mobility, implanted plates, pins, or screws that limit mobility, fractures or recent surgeries or any other physical condition that could interfere with the ability to play an active video game
- co-occurring neurological conditions such as numbness or muscle weakness, temporary loss of vision, speech or strength, loss of consciousness (black out), Dizziness or lightheadedness, Impaired memory or confusion, any other cooccurring diagnosis that could be negatively impacted by playing an active video game
- any other health conditions that are contraindicated to or may interfere with physical activity such as impaired hearing (uncorrected), medically documented balance disorder, Any heart condition prohibiting exercise, chronic pain or any pain at the time of testing, need assistance to stand for 20 minutes or more,
- aggression or other severe behaviors that may limit the ability to safely participate in the intervention.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Bloomington
Bloomington, Indiana, 47405
About this study
Official title: Effect of Virtual Reality-based Training on Postural Control in Youth With Autism Spectrum Disorder
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.
Read more
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.
Read the detailed description
Postural control deficits, also referred to as balance deficits, are a noted example of impaired motor-skills and are increasingly considered as one of the primary markers for autism spectrum disorder (ASD)1-5. However, there are very few controlled clinical trials examining effects of balance interventions in individuals with ASD. Moreover, to date there exist few effective interventions based on well-designed research that address balance deficits in youth with ASD and are home-implemented, cost-effective, generalizable, and enjoyable and that promote adherence. Virtual reality (VR) active gaming is one such intervention that incorporates scientific mechanisms for improving balance. But, there exist few, evidence-based best practices that use this method to address balance in youth with ASD. In addition to being based on principles of motor learning/control, commercially available VR active gaming can be affordable, enjoyable, at-home intervention. Thus, the aim of this study 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.
This study will take place at the Physical Activity and Biomechanics Labs at School of Public Health, Indiana University, Bloomington, and participants home for total of 9 sessions occurring over 7-8 weeks.
Before participants come to the lab:
Participants' parent/guardian will complete a couple of questionnaires that will ask questions about any medications that participant takes and about participants' physical health to make sure it is safe for the participant to participate in the study. They will also answer questions that are used to determine if someone might have ASD.
Participants will be shown a video which will give them information about the lab they will be coming to do some of the study activities, and information about the people that will be working with them during the study. Participants will then be randomly assigned (like flipping a coin) to one of two groups: the Virtual Reality Group, or the Exercise Group. This will determine what activities or exercise they will do for the upcoming sessions.
Session #1, about 90 minutes:
Researchers measure participants height, weight, and length of arm and leg. Researchers will also measure which hand participants prefer to perform daily activities using Edinburgh Handedness Inventory- short form (EHI-SF). Participants will also stand on a large mat containing sensors that will measure how much their body moves back and forth while they are standing. Participants will stand on the mat for 30 seconds with their eyes open, and then for 30 seconds with their eyes closed.
Then, researchers will measure how well participants are able to balance by having them do some activities like sitting and standing without help, standing with their eyes closed, reaching forward with their arms stretched in front, placing their right then left foot on a stool, standing with alternating foot in front, and standing on one foot, alternating right and left. The researcher will show the participants how to do each of these, and they can practice a couple of times before the test begins.
Participants will then do some walking in the lab with special sensors that are attached to their lower back and feet. This will measure how participants walk. The sensors are attached with special tape to the cloths and shoes, and are not painful. A special camera will take pictures as the participants walk, and video recording will be done as well. Participants will do this several times and will be reminded to walk at a normal pace.
Lastly, if the participants are in the Virtual Reality Group, their parent/guardian will receive the Nintendo switch™ console and the sports game to take home.
At home, 3 times a week for two weeks for 30-40 minutes (Sessions 2-7):
- If participants are in the Virtual Reality Group, they will choose 2 video games on the Nintendo Switch from golf, Frisbee, beach tennis, soccer, Volleyball, badminton, bowling, and Chambara. Games will be played for 10 minutes each with a 5-minute break in-between. The same 2 games will be played at each session in the same sequence. Researchers will provide verbal prompts and encouragement during the games as they watch participants via Zoom. Each session will take approximately 30-40 minutes. Ideally, each session will occur with an off day in between, however this may not be realistic depending on participants schedules and so sessions will occur at their convenience.
- If participants are in the Exercise Group, they will perform balance exercises for 15 minutes with 5 minutes of warm and cool down each. Some of the exercises are standing with one foot in front of the other for 10 seconds, standing on 1 foot for 10 seconds, standing with feet together etc. Breaks will be given, and they will be given instructions and encouragement by the researcher who will be watching via Zoom.
Sessions 8 and 9 (in the lab), about an hour:
Session #8: 3-5 days after session 7, Participants will complete all the balance and walking measurements that they did in session #1 excluding parameters such as EHI-SF, leg and arm length, weight, height. It will take approximately 1 hour.
On session #9: 4 weeks after session #7, participants will once again complete all the same activities they completed during visit #8. It will take approximately 1 hour.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Virtual reality active video gaming using Nintendo switch sports, Standard physical therapy balance exercises
- Keywords
- Autism Spectrum Disorder, Balance exercises, Virtual reality, Active video gaming, Gait
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality active video gaming using Nintendo switch sportsDevice
Playing 2 pre-selected VR active video games from beach tennis, soccer, volleyball, badminton, bowling, and chambara for 10 minutes each with a 5 minute break in-between. Total duration 30-40 minutes.
Standard physical therapy balance exercisesBehavioural
Balance exercises: Standing with feet together for 10 seconds 5 times, standing with 1 foot in front of other for 10 seconds 5 times on both sides, standing on one leg for 10 seconds 5 times on both sides, walking with one foot in front of other on a 1-meter-long line for 5 repetitions and standing on a balance board for 30 seconds for 3 repetitions. 5 minutes each of warm-up and cool down exercises. Total duration 20-30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality active video gaming | Experimental | The participants in this group will engage in VR active gaming using Nintendo Switch Sports under supervision via Zoom, for 6 sessions over 2 weeks. Receives: Device: Virtual reality active video gaming using Nintendo switch sports |
| Standard balance exercises | Active comparator | The participants in this group will engage in standard physical therapy exercises for balance and walking under supervision via Zoom, for 6 sessions over 2 weeks. Receives: Behavioral: Standard physical therapy balance exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Center of Pressure Movement (Postural Sway Velocity)
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
Measured: 5 days before the intervention, 5 days after the intervention and 4 weeks after the intervention
Change in Pediatric Berg's Balance Scale Score
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.
Measured: 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention
Change in Step Length (Meters) of the Gait
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).
Measured: 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention
Change in Stride Width (Meters) of the Gait
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).
Measured: 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention
Change in Stride Length (Meters) of the Gait
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).
Measured: 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention
Change in Double Support Period (Seconds) of the Gait
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).
Measured: 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention
Change in the Cadence (Steps/Minute) of the Gait
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).
Measured: 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention
Change in Gait Velocity (Meters/Second)
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).
Measured: 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start15 May 2023
- Primary completion19 Apr 2024
- Study completion19 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups, intervention and the control, will be compared within and between longitudinally 3 times. Before-, after- and 4 weeks after the intervention.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgia Frey, Indiana University
- Investigators
- Georgia Frey, Ph.D., Principal investigator, Indiana University, Bloomington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023563
- Sponsor's protocol ID
- 19116
- Status last verified
- May 2026
- First submitted
- 17 Jul 2023
- Last updated
- 2 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared to maintain the confidentiality of the participants.
Publications
Nobile M, Perego P, Piccinini L, Mani E, Rossi A, Bellina M, Molteni M. Further evidence of complex motor dysfunction in drug naive children with autism using automatic motion analysis of gait. Autism. 2011 May;15(3):263-83. doi: 10.1177/1362361309356929. Epub 2011 Apr 8.
PubMed 21478224Lim YH, Partridge K, Girdler S, Morris SL. Standing Postural Control in Individuals with Autism Spectrum Disorder: Systematic Review and Meta-analysis. J Autism Dev Disord. 2017 Jul;47(7):2238-2253. doi: 10.1007/s10803-017-3144-y.
PubMed 28508177Harris SR. Early motor delays as diagnostic clues in autism spectrum disorder. Eur J Pediatr. 2017 Sep;176(9):1259-1262. doi: 10.1007/s00431-017-2951-7. Epub 2017 Jun 28.
PubMed 28660313Li Y, Liu T, Venuti CE. Development of postural stability in children with autism spectrum disorder: a cross-sectional study. Int Biomech. 2021 Dec;8(1):54-62. doi: 10.1080/23335432.2021.1968316.
PubMed 34414860Minshew NJ, Sung K, Jones BL, Furman JM. Underdevelopment of the postural control system in autism. Neurology. 2004 Dec 14;63(11):2056-61. doi: 10.1212/01.wnl.0000145771.98657.62.
PubMed 15596750Mazurek MO, Shattuck PT, Wagner M, Cooper BP. Prevalence and correlates of screen-based media use among youths with autism spectrum disorders. J Autism Dev Disord. 2012 Aug;42(8):1757-67. doi: 10.1007/s10803-011-1413-8.
PubMed 22160370Ye S, Lee JE, Stodden DF, Gao Z. Impact of Exergaming on Children's Motor Skill Competence and Health-Related Fitness: A Quasi-Experimental Study. J Clin Med. 2018 Sep 7;7(9):261. doi: 10.3390/jcm7090261.
PubMed 30205483Bhat AN, Landa RJ, Galloway JC. Current perspectives on motor functioning in infants, children, and adults with autism spectrum disorders. Phys Ther. 2011 Jul;91(7):1116-29. doi: 10.2522/ptj.20100294. Epub 2011 May 5.
PubMed 21546566Ruggeri A, Dancel A, Johnson R, Sargent B. The effect of motor and physical activity intervention on motor outcomes of children with autism spectrum disorder: A systematic review. Autism. 2020 Apr;24(3):544-568. doi: 10.1177/1362361319885215. Epub 2019 Nov 29.
PubMed 31782658Zampella CJ, Wang LAL, Haley M, Hutchinson AG, de Marchena A. Motor Skill Differences in Autism Spectrum Disorder: a Clinically Focused Review. Curr Psychiatry Rep. 2021 Aug 13;23(10):64. doi: 10.1007/s11920-021-01280-6.
PubMed 34387753Jelsma D, Geuze RH, Mombarg R, Smits-Engelsman BC. The impact of Wii Fit intervention on dynamic balance control in children with probable Developmental Coordination Disorder and balance problems. Hum Mov Sci. 2014 Feb;33:404-18. doi: 10.1016/j.humov.2013.12.007. Epub 2014 Jan 18.
PubMed 24444657Rafiei Milajerdi H, Sheikh M, Najafabadi MG, Saghaei B, Naghdi N, Dewey D. The Effects of Physical Activity and Exergaming on Motor Skills and Executive Functions in Children with Autism Spectrum Disorder. Games Health J. 2021 Feb;10(1):33-42. doi: 10.1089/g4h.2019.0180. Epub 2020 Dec 23.
PubMed 33370161Travers BG, Mason AH, Mrotek LA, Ellertson A, Dean DC 3rd, Engel C, Gomez A, Dadalko OI, McLaughlin K. Biofeedback-Based, Videogame Balance Training in Autism. J Autism Dev Disord. 2018 Jan;48(1):163-175. doi: 10.1007/s10803-017-3310-2.
PubMed 28921103Caldani S, Atzori P, Peyre H, Delorme R, Bucci MP. Short rehabilitation training program may improve postural control in children with autism spectrum disorders: preliminary evidences. Sci Rep. 2020 May 13;10(1):7917. doi: 10.1038/s41598-020-64922-4.
PubMed 32404919Franjoine MR, Gunther JS, Taylor MJ. Pediatric balance scale: a modified version of the berg balance scale for the school-age child with mild to moderate motor impairment. Pediatr Phys Ther. 2003 Summer;15(2):114-28. doi: 10.1097/01.PEP.0000068117.48023.18.
PubMed 17057441
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality-based Training on Postural Control in Youth With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06023563
- Acronym / sponsor ID
- 19116
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Balance exercises, Virtual reality, Active video gaming, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 5 Sep 2023 (actual)
- Results
- Posted 12 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Postural control deficits, also referred to as balance deficits, are a noted example of impaired motor-skills and are increasingly considered as one of the primary markers for autism spectrum disorder (ASD)1-5. However, there are very few controlled clinical trials examining effects of balance interventions in individuals with ASD. Moreover, to date there exist few effective interventions based on well-designed research that address balance deficits in youth with ASD and are home-implemented, cost-effective, generalizable, and enjoyable and that promote adherence. Virtual reality (VR) active gaming is one such intervention that incorporates scientific mechanisms for improving balance. But, there exist few, evidence-based best practices that use this method to address balance in youth with ASD. In addition to being based on principles of motor learning/control, commercially available VR active gaming can be affordable, enjoyable, at-home intervention. Thus, the aim of this study 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.
This study will take place at the Physical Activity and Biomechanics Labs at School of Public Health, Indiana University, Bloomington, and participants home for total of 9 sessions occurring over 7-8 weeks.
Before participants come to the lab:
Participants' parent/guardian will complete a couple of questionnaires that will ask questions about any medications that participant takes and about participants' physical health to make sure it is safe for the participant to participate in the study. They will also answer questions that are used to determine if someone might have ASD.
Participants will be shown a video which will give them information about the lab they will be coming to do some of the study activities, and information about the people that will be working with them during the study. Participants will then be randomly assigned (like flipping a coin) to one of two groups: the Virtual Reality Group, or the Exercise Group. This will determine what activities or exercise they will do for the upcoming sessions.
Session #1, about 90 minutes:
Researchers measure participants height, weight, and length of arm and leg. Researchers will also measure which hand participants prefer to perform daily activities using Edinburgh Handedness Inventory- short form (EHI-SF). Participants will also stand on a large mat containing sensors that will measure how much their body moves back and forth while they are standing. Participants will stand on the mat for 30 seconds with their eyes open, and then for 30 seconds with their eyes closed.
Then, researchers will measure how well participants are able to balance by having them do some activities like sitting and standing without help, standing with their eyes closed, reaching forward with their arms stretched in front, placing their right then left foot on a stool, standing with alternating foot in front, and standing on one foot, alternating right and left. The researcher will show the participants how to do each of these, and they can practice a couple of times before the test begins.
Participants will then do some walking in the lab with special sensors that are attached to their lower back and feet. This will measure how participants walk. The sensors are attached with special tape to the cloths and shoes, and are not painful. A special camera will take pictures as the participants walk, and video recording will be done as well. Participants will do this several times and will be reminded to walk at a normal pace.
Lastly, if the participants are in the Virtual Reality Group, their parent/guardian will receive the Nintendo switch™ console and the sports game to take home.
At home, 3 times a week for two weeks for 30-40 minutes (Sessions 2-7):
- If participants are in the Virtual Reality Group, they will choose 2 video games on the Nintendo Switch from golf, Frisbee, beach tennis, soccer, Volleyball, badminton, bowling, and Chambara. Games will be played for 10 minutes each with a 5-minute break in-between. The same 2 games will be played at each session in the same sequence. Researchers will provide verbal prompts and encouragement during the games as they watch participants via Zoom. Each session will take approximately 30-40 minutes. Ideally, each session will occur with an off day in between, however this may not be realistic depending on participants schedules and so sessions will occur at their convenience.
- If participants are in the Exercise Group, they will perform balance exercises for 15 minutes with 5 minutes of warm and cool down each. Some of the exercises are standing with one foot in front of the other for 10 seconds, standing on 1 foot for 10 seconds, standing with feet together etc. Breaks will be given, and they will be given instructions and encouragement by the researcher who will be watching via Zoom.
Sessions 8 and 9 (in the lab), about an hour:
Session #8: 3-5 days after session 7, Participants will complete all the balance and walking measurements that they did in session #1 excluding parameters such as EHI-SF, leg and arm length, weight, height. It will take approximately 1 hour.
On session #9: 4 weeks after session #7, participants will once again complete all the same activities they completed during visit #8. It will take approximately 1 hour.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups, intervention and the control, will be compared within and between longitudinally 3 times. Before-, after- and 4 weeks after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Virtual reality active video gaming | Experimental | Device: Virtual reality active video gaming using Nintendo switch sportsThe participants in this group will engage in VR active gaming using Nintendo Switch Sports under supervision via Zoom, for 6 sessions over 2 weeks. |
| Standard balance exercises | Active comparator | Behavioral: Standard physical therapy balance exercisesThe participants in this group will engage in standard physical therapy exercises for balance and walking under supervision via Zoom, for 6 sessions over 2 weeks. |
Who may qualify
- Ages
- 7 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- age 7-22 years,
- existing ASD DSM-5 level 1 or 2 diagnosis confirmed by medical record/ educational services categorized under ASD/ therapeutic services categorized under ASD/ any other official document indicating the diagnosis of ASD,
- able to follow instructions and
- able to stand unsupported for at least 20 minutes.
Key exclusion criteria (6 listed)
- epilepsy or other medical conditions which can be exacerbated by looking at a screen,
- Uncorrected vision loss or any other eye condition prohibiting looking at the screen for a prolong time,
- co-occurring musculoskeletal conditions such as joint or muscle pain or stiffness that limits mobility, implanted plates, pins, or screws that limit mobility, fractures or recent surgeries or any other physical condition that could interfere with the ability to play an active video game
- co-occurring neurological conditions such as numbness or muscle weakness, temporary loss of vision, speech or strength, loss of consciousness (black out), Dizziness or lightheadedness, Impaired memory or confusion, any other cooccurring diagnosis that could be negatively impacted by playing an active video game
- any other health conditions that are contraindicated to or may interfere with physical activity such as impaired hearing (uncorrected), medically documented balance disorder, Any heart condition prohibiting exercise, chronic pain or any pain at the time of testing, need assistance to stand for 20 minutes or more,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality active video gaming using Nintendo switch sportsPlaying 2 pre-selected VR active video games from beach tennis, soccer, volleyball, badminton, bowling, and chambara for 10 minutes each with a 5 minute break in-between. Total duration 30-40 minutes. | Device | Virtual reality active video gaming |
| Standard physical therapy balance exercisesBalance exercises: Standing with feet together for 10 seconds 5 times, standing with 1 foot in front of other for 10 seconds 5 times on both sides, standing on one leg for 10 seconds 5 times on both sides, walking with one foot in front of other on a 1-meter-long line for 5 repetitions and standing on a balance board for 30 seconds for 3 repetitions. 5 minutes each of warm-up and cool down exercises. Total duration 20-30 minutes. | Behavioural | Standard balance exercises |
Primary outcome
Change in the Center of Pressure Movement (Postural Sway Velocity)
Time frame: 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
Change in Pediatric Berg's Balance Scale Score
Time frame: 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.
Change in Step Length (Meters) of the Gait
Time frame: 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).
Change in Stride Width (Meters) of the Gait
Time frame: 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).
Change in Stride Length (Meters) of the Gait
Time frame: 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).
Change in Double Support Period (Seconds) of the Gait
Time frame: 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).
Change in the Cadence (Steps/Minute) of the Gait
Time frame: 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).
Change in Gait Velocity (Meters/Second)
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21478224Nobile M, Perego P, Piccinini L, Mani E, Rossi A, Bellina M, Molteni M. Further evidence of complex motor dysfunction in drug naive children with autism using automatic motion analysis of gait. Autism. 2011 May;15(3):263-83. doi: 10.1177/1362361309356929. Epub 2011 Apr 8.
- Background: PubMed 28508177Lim YH, Partridge K, Girdler S, Morris SL. Standing Postural Control in Individuals with Autism Spectrum Disorder: Systematic Review and Meta-analysis. J Autism Dev Disord. 2017 Jul;47(7):2238-2253. doi: 10.1007/s10803-017-3144-y.
- Background: PubMed 28660313Harris SR. Early motor delays as diagnostic clues in autism spectrum disorder. Eur J Pediatr. 2017 Sep;176(9):1259-1262. doi: 10.1007/s00431-017-2951-7. Epub 2017 Jun 28.
- Background: PubMed 34414860Li Y, Liu T, Venuti CE. Development of postural stability in children with autism spectrum disorder: a cross-sectional study. Int Biomech. 2021 Dec;8(1):54-62. doi: 10.1080/23335432.2021.1968316.
- Background: PubMed 15596750Minshew NJ, Sung K, Jones BL, Furman JM. Underdevelopment of the postural control system in autism. Neurology. 2004 Dec 14;63(11):2056-61. doi: 10.1212/01.wnl.0000145771.98657.62.
- Background: PubMed 22160370Mazurek MO, Shattuck PT, Wagner M, Cooper BP. Prevalence and correlates of screen-based media use among youths with autism spectrum disorders. J Autism Dev Disord. 2012 Aug;42(8):1757-67. doi: 10.1007/s10803-011-1413-8.
- Background: PubMed 30205483Ye S, Lee JE, Stodden DF, Gao Z. Impact of Exergaming on Children's Motor Skill Competence and Health-Related Fitness: A Quasi-Experimental Study. J Clin Med. 2018 Sep 7;7(9):261. doi: 10.3390/jcm7090261.
- Background: PubMed 21546566Bhat AN, Landa RJ, Galloway JC. Current perspectives on motor functioning in infants, children, and adults with autism spectrum disorders. Phys Ther. 2011 Jul;91(7):1116-29. doi: 10.2522/ptj.20100294. Epub 2011 May 5.
- Background: PubMed 31782658Ruggeri A, Dancel A, Johnson R, Sargent B. The effect of motor and physical activity intervention on motor outcomes of children with autism spectrum disorder: A systematic review. Autism. 2020 Apr;24(3):544-568. doi: 10.1177/1362361319885215. Epub 2019 Nov 29.
- Background: PubMed 34387753Zampella CJ, Wang LAL, Haley M, Hutchinson AG, de Marchena A. Motor Skill Differences in Autism Spectrum Disorder: a Clinically Focused Review. Curr Psychiatry Rep. 2021 Aug 13;23(10):64. doi: 10.1007/s11920-021-01280-6.
- Background: PubMed 24444657Jelsma D, Geuze RH, Mombarg R, Smits-Engelsman BC. The impact of Wii Fit intervention on dynamic balance control in children with probable Developmental Coordination Disorder and balance problems. Hum Mov Sci. 2014 Feb;33:404-18. doi: 10.1016/j.humov.2013.12.007. Epub 2014 Jan 18.
- Background: PubMed 33370161Rafiei Milajerdi H, Sheikh M, Najafabadi MG, Saghaei B, Naghdi N, Dewey D. The Effects of Physical Activity and Exergaming on Motor Skills and Executive Functions in Children with Autism Spectrum Disorder. Games Health J. 2021 Feb;10(1):33-42. doi: 10.1089/g4h.2019.0180. Epub 2020 Dec 23.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to maintain the confidentiality of the participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgia Frey, Ph.D. principal investigator
Indiana University, Bloomington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality active video gaming using Nintendo switch sports and Standard physical therapy balance exercises in people with Autism Spectrum Disorder, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Center of Pressure Movement (Postural Sway Velocity) (time frame: 5 days before the intervention, 5 days after the intervention and 4 weeks after the intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06023563, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.