Leveraging Extended Reality Exergaming and Telehealth to Improve Physical Activity and Health in Children With Disabilities
2026年5月11日 更新者：Byron Lai、University of Alabama at Birmingham
This phase II RCT evaluates the efficacy of a telehealth-delivered extended reality (XR) exergaming intervention on physical activity, cardiometabolic health, and physical fitness in physically inactive children with cerebral palsy (ages 10 to 17).
A total of 130 participants will be randomized to either a 12-week XR exergaming intervention with behavioral coaching or a non-intervention control group, followed by a 24-week sustainability phase.
Aim 1 examines immediate and sustained effects on physical activity levels.
Aim 2 tests effects on cardiometabolic health indicators including blood lipids, blood pressure, and glycemic markers.
Aim 3 explores effects on physical fitness and perceived health.
All procedures are conducted remotely via telehealth.
研究概览
研究类型
介入性
注册 (估计的)
130
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Byron Lai, MS, PhD
- 电话号码：89725 205-638-9790
- 邮箱：blai@uabmc.edu
学习地点
-
-
Alabama
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Birmingham、Alabama、美国、35233
- University of Alabama at Birmingham
-
接触：
- Byron Lai, MS, PhD
- 电话号码：89725 205-638-9790
- 邮箱：blai@uabmc.edu
-
Birmingham、Alabama、美国、32533
- Children's of Alabama
-
接触：
- Byron Lai, MS, PhD
- 电话号码：89725 205-638-9790
- 邮箱：blai@uabmc.edu
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
不
描述
Inclusion Criteria:
- medical diagnosis of cerebral palsy
- between the ages of 10-17 years (10 years of age is the minimum requirement of the Meta Quest 3s headset, as noted by the manufacturer)
- physician clearance to participate in moderate-intensity exercise
- access to a Wi-Fi Internet connection in the home
- a caregiver that is committed to supporting the child with setting up and assisting with the prescribed exergaming and managing the study activities
Exclusion Criteria:
- physically active (defined as ≥150 minutes per week of moderate-to-vigorous intensity exercise in a typical week)
- prone to photosensitive seizures
- a classification of GMFCS level V, which we have found to preclude the ability to use the Oculus Quest hand-held controllers
- complete blindness or deafness
- unable to communicate in English (participant and caregiver)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Extended Reality Gaming (XRG)
Immediate start of extended reality exercise program for 36 weeks.
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Seated arm exercise using an extended reality headset for 36 weeks.
|
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无干预：Non-intervention Control
Continue habitual activities for 36 weeks.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Godin Leisure Time Exercise Questionnaire
大体时间：week 0, week 6, week 12, week 24, week 36
|
The GLTEQ is a 7-day recall survey.
The GLTEQ will be scored using a health contribution (HC) score, which equates an HC score of ≥24 to the minimum aerobic guideline of 150 mins/week of moderate exercise.
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week 0, week 6, week 12, week 24, week 36
|
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Daily Step Count
大体时间：weeks 0-36
|
Steps per day, captured using the Polar Unite wrist watch.
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weeks 0-36
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in C-reactive Protein (hsCRP)
大体时间：week 0, week 6, week 12, week 24, week 36
|
hsCRP (mg/L) is a critical marker of inflammation that contributes to pro-inflammatory and pro-thrombotic elements of CVD risk.
A single hsCRP measure is a strong predictor of myocardial infarction or coronary heart disease mortality, and several other diseases of the circulatory system in people without a history of such conditions.
|
week 0, week 6, week 12, week 24, week 36
|
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Changes in Hemoglobin A1C
大体时间：week 0, week 6, week 12, week 24, week 36
|
HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months.
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week 0, week 6, week 12, week 24, week 36
|
|
Changes in Fasting Insulin
大体时间：week 0, week 6, week 12, week 24, week 36
|
High fasting insulin indicates the presence of insulin resistance.
Exercise interventions can expect a small beneficial change in fasting insulin levels after 1-month of training.
|
week 0, week 6, week 12, week 24, week 36
|
|
Changes in Fasting Triglycerides
大体时间：week 0, week 6, week 12, week 24, week 36
|
A triglyceride level >150 mg/dL, is largely supported as an indicator of CVD risk.
Exercise interventions can expect a small beneficial change in triglyceride levels following 1-month of training, even among people with normal triglyceride levels.
|
week 0, week 6, week 12, week 24, week 36
|
|
Changes in High-density Lipoprotein
大体时间：week 0, week 6, week 12, week 24, week 36
|
High-density lipoprotein (HDL; mg/dL) cholesterol is a predictor of future CVD among young and middle-aged people.
Exercise interventions can expect a small effect after 1-month of training.
|
week 0, week 6, week 12, week 24, week 36
|
|
Changes in Low-density Lipoprotein
大体时间：week 0, week 6, week 12, week 24, week 36
|
Low-density lipoprotein (LDL; mg/dL) cholesterol is a predictor of future CVD among young and middle-aged people.
Exercise interventions can expect a small effect after 1-month of training.
|
week 0, week 6, week 12, week 24, week 36
|
|
Changes in Total Cholesterol
大体时间：week 0, week 6, week 12, week 24, week 36
|
Total cholesterol (mg/dL) is a predictor of future CVD among young and middle-aged people.
Exercise interventions can expect a small effect after 1-month of training.
|
week 0, week 6, week 12, week 24, week 36
|
|
Changes in Resting Systolic Blood Pressure
大体时间：week 0, week 6, week 12, week 24, week 36
|
Elevated blood pressure (mmHg) during childhood and adolescents is associated with intermediate markers and hard outcomes of CVD in adulthood.
Moderate-intensity exercise is negatively associated with blood pressure.
Small changes in blood pressure can occur from as early as 1-month of endurance training.
|
week 0, week 6, week 12, week 24, week 36
|
|
Changes in Resting Diastolic Blood Pressure
大体时间：week 0, week 6, week 12, week 24, week 36
|
Elevated blood pressure (mmHg) during childhood and adolescents is associated with intermediate markers and hard outcomes of CVD in adulthood.
Moderate-intensity exercise is negatively associated with blood pressure.
Small changes in blood pressure can occur from as early as 1-month of endurance training.
|
week 0, week 6, week 12, week 24, week 36
|
|
2-Minute Step Test
大体时间：Week 0, Week 6, Week 12, Week 24, Week 36
|
2 minute test is used to assess aerobic capacity by counting the number of steps an individual takes, hitting a target point, in 2 minutes.
Individuals can hold on to supports for duration of the test.
2-minute step test will be for only ambulatory individuals.
Higher number of steps in 2-minutes equates to higher aerobic capacity.
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Week 0, Week 6, Week 12, Week 24, Week 36
|
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Timed Up and Go (TUG)
大体时间：Week 0, Week 6, Week 12, Week 24, Week 36
|
TUG is a 3-meter walking test to assess an individuals functional balance and mobility.
Individuals will start in a seated position, stand, walk 3-meters turning around a cone, walk back and sit down.
Time will be measured in seconds, with lower time equating to higher functional balance and mobility.
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Week 0, Week 6, Week 12, Week 24, Week 36
|
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Hand-grip Strength Test (hand-held dynamometer)
大体时间：Week 0, Week 6, Week 12, Week 24, Week 36
|
Measure of isometric muscular strength of the hand and forearm.
Using a hand-held dynamometer, individuals will hold onto device with arm supported at a 90 degree angle and squeeze as hard as they can for 3 seconds.
Individuals will do 3 test on each hand, as able, with the average of the 3 attempt being their score.
Hand-grip strength will be measured in kg, with higher values equating to more strength.
|
Week 0, Week 6, Week 12, Week 24, Week 36
|
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NIH PROMIS Global Health Pediatric (7 item) survey
大体时间：Week 0, Week 6, Week 12, Week 24, Week 36
|
7-item survey assessing a child's self-reported health, including physical, mental, and social health.
Each question is given a score of 1-5.
The sum of all 7 questions will be used to determine the individuals total score which will be referenced to a z-score conversion table, with higher scores equating to better overall health.
|
Week 0, Week 6, Week 12, Week 24, Week 36
|
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Changes in Body Weight
大体时间：Week 0,Week 6, Week 12, Week 24, Week 36
|
Body weight measured in lbs using a off-the-shelf bathroom scale.
|
Week 0,Week 6, Week 12, Week 24, Week 36
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Byron Lai, MS, PhD、University of Alabama at Birmingham
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年12月1日
初级完成 (估计的)
2031年3月9日
研究完成 (估计的)
2031年5月31日
研究注册日期
首次提交
2026年4月27日
首先提交符合 QC 标准的
2026年4月27日
首次发布 (实际的)
2026年5月4日
研究记录更新
最后更新发布 (实际的)
2026年5月14日
上次提交的符合 QC 标准的更新
2026年5月11日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.