Leveraging Extended Reality Exergaming and Telehealth to Improve Physical Activity and Health in Children With Disabilities
11 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
130
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Byron Lai, MS, PhD
- Numéro de téléphone: 89725 205-638-9790
- E-mail: blai@uabmc.edu
Lieux d'étude
-
-
Alabama
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Birmingham, Alabama, États-Unis, 35233
- University of Alabama at Birmingham
-
Contact:
- Byron Lai, MS, PhD
- Numéro de téléphone: 89725 205-638-9790
- E-mail: blai@uabmc.edu
-
Birmingham, Alabama, États-Unis, 32533
- Children's of Alabama
-
Contact:
- Byron Lai, MS, PhD
- Numéro de téléphone: 89725 205-638-9790
- E-mail: blai@uabmc.edu
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Non
La description
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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: Non-intervention Control
Continue habitual activities for 36 weeks.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Godin Leisure Time Exercise Questionnaire
Délai: 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
|
|
Daily Step Count
Délai: weeks 0-36
|
Steps per day, captured using the Polar Unite wrist watch.
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weeks 0-36
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in C-reactive Protein (hsCRP)
Délai: 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
|
|
Changes in Hemoglobin A1C
Délai: week 0, week 6, week 12, week 24, week 36
|
HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months.
|
week 0, week 6, week 12, week 24, week 36
|
|
Changes in Fasting Insulin
Délai: 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
Délai: 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
|
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Changes in High-density Lipoprotein
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
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Changes in Resting Diastolic Blood Pressure
Délai: 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
Délai: 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)
Délai: 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)
Délai: Week 0, Week 6, Week 12, Week 24, Week 36
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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.
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Week 0, Week 6, Week 12, Week 24, Week 36
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NIH PROMIS Global Health Pediatric (7 item) survey
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Byron Lai, MS, PhD, University of Alabama at Birmingham
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 décembre 2026
Achèvement primaire (Estimé)
9 mars 2031
Achèvement de l'étude (Estimé)
31 mai 2031
Dates d'inscription aux études
Première soumission
27 avril 2026
Première soumission répondant aux critères de contrôle qualité
27 avril 2026
Première publication (Réel)
4 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB-300016599
- UAB (Autre identifiant: UAB)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
All collected IPD.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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