Effect of Virtual Reality-based Training on Postural Control in Youth With Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change in the Center of Pressure Movement (Postural Sway Velocity)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Virtual reality active video gaming
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.
干预措施: Virtual reality active video gaming using Nintendo switch sports (Device)
Standard balance exercises
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.
干预措施: Standard physical therapy balance exercises (Behavioral)
结局指标
主要结局
Change in the Center of Pressure Movement (Postural Sway Velocity)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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).
次要结局
未报告次要终点
研究者
Georgia Frey
Associate Professor, Public Health
Indiana University