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

NCT06023563 | Completed Results FDA Device

• 1 other identifier: 19116
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Balance exercises; Virtual reality; Active video gaming; Gait

Outcome Measures

Primary Outcomes (8)

• 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

  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.

  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).

  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).

  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).

  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).

  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).

  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).

  5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention

Study Arms (2)

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.

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.

Behavioral: Standard physical therapy balance exercises

Interventions

Virtual reality active video gaming using Nintendo switch sports DEVICE

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.

Virtual reality active video gaming

Standard physical therapy balance exercises BEHAVIORAL

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.

Standard balance exercises

Eligibility Criteria

• Age: 7 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Bloomington

Bloomington, Indiana, 47405, United States

Location

Related Publications (17)

• 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.

  PMID: 21478224 BACKGROUND

• Lim 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.

  PMID: 28508177 BACKGROUND

• Harris 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.

  PMID: 28660313 BACKGROUND

• Li 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.

  PMID: 34414860 BACKGROUND

• Minshew 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.

  PMID: 15596750 BACKGROUND

• Mazurek 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.

  PMID: 22160370 BACKGROUND

• Ye 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.

  PMID: 30205483 BACKGROUND

• Bhat 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.

  PMID: 21546566 BACKGROUND

• Ruggeri 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.

  PMID: 31782658 BACKGROUND

• Zampella 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.

  PMID: 34387753 BACKGROUND

• Jelsma 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.

  PMID: 24444657 BACKGROUND

• Rafiei 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.

  PMID: 33370161 BACKGROUND

• Travers 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.

  PMID: 28921103 BACKGROUND

• Caldani 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.

  PMID: 32404919 BACKGROUND

• Franjoine 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.

  PMID: 17057441 BACKGROUND

• Goetschius J, Feger MA, Hertel J, Hart JM. Validating Center-of-Pressure Balance Measurements Using the MatScan(R) Pressure Mat. J Sport Rehabil. 2018 Jan 1;27(1). doi: 10.1123/jsr.2017-0152. Epub 2018 Jan 24.

  PMID: 28714837 BACKGROUND

• Chen CL, Shen IH, Chen CY, Wu CY, Liu WY, Chung CY. Validity, responsiveness, minimal detectable change, and minimal clinically important change of Pediatric Balance Scale in children with cerebral palsy. Res Dev Disabil. 2013 Mar;34(3):916-22. doi: 10.1016/j.ridd.2012.11.006. Epub 2013 Jan 3.

  PMID: 23291508 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

Limitations: Both interventions were carried out under video supervision, and this may have impacted motivation. All balance data was collected in laboratory-based setting. Findings therefore may not be generalizable to postural balance mechanics during outdoor or free-living walking. Gender-based differences were present in the sample as prevalence of ASD is 4:1 male to female ratio

Results Point of Contact

• Title: Dr. Georgia Frey, Faculty, Department of Kinesiology
• Organization: Indiana University

gfrey@iu.edu

(812) 855-1262

Study Officials

• Georgia Frey, Ph.D.

  Indiana University, Bloomington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Public Health

Model Details: Two groups, intervention and the control, will be compared within and between longitudinally 3 times. Before-, after- and 4 weeks after the intervention.

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: September 5, 2023
• Study Start: May 15, 2023
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: August 12, 2025
• Results First Posted: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)