Clinical trial NCT06023563: Effect of Virtual Reality-based Training on Balance and Walking in Youth With Autism Spectrum Disorder
Official title: Effect of Virtual Reality-based Training on Postural Control in Youth With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
Balance exercises
Virtual reality
Active video gaming
Gait
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 12
Sex: ALL
Minimum age (years): 7
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in the center of pressure movement
timeFrame: 3-5 days before the intervention, 3-5 days after the intervention and 4 weeks after the intervention
measure: Change in Pediatric Berg's Balance Scale score
timeFrame: 3-5 days before the intervention, 3-5 days after the intervention, 4 weeks after the intervention
measure: Change in step length (meters) of the gait
timeFrame: 3-5 days before the intervention, 3-5 days after the intervention, 4 weeks after the intervention
measure: Change in step width (meters) of the gait
timeFrame: 3-5 days before the intervention, 3-5 days after the intervention, 4 weeks after the intervention
measure: Change in stride length (meters) of the gait
timeFrame: 3-5 days before the intervention, 3-5 days after the intervention, 4 weeks after the intervention
measure: Change in double support period (seconds) of the gait
timeFrame: 3-5 days before the intervention, 3-5 days after the intervention, 4 weeks after the intervention
measure: Change in the cadence (steps/minute) of the gait
timeFrame: 3-5 days before the intervention, 3-5 days after the intervention, 4 weeks after the intervention
measure: Change in gait velocity (meters/second)
timeFrame: 3-5 days before the intervention, 3-5 days after the intervention, 4 weeks after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University Bloomington
state: Indiana
Study officials:
affiliation: Indiana University, Bloomington
name: Georgia Frey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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