Leveraging Extended Reality Exergaming and Telehealth to Improve Physical Activity and Health in Children With Disabilities
11 de maio de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
130
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Byron Lai, MS, PhD
- Número de telefone: 89725 205-638-9790
- E-mail: blai@uabmc.edu
Locais de estudo
-
-
Alabama
-
Birmingham, Alabama, Estados Unidos, 35233
- University of Alabama at Birmingham
-
Contato:
- Byron Lai, MS, PhD
- Número de telefone: 89725 205-638-9790
- E-mail: blai@uabmc.edu
-
Birmingham, Alabama, Estados Unidos, 32533
- Children's of Alabama
-
Contato:
- Byron Lai, MS, PhD
- Número de telefone: 89725 205-638-9790
- E-mail: blai@uabmc.edu
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Não
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Extended Reality Gaming (XRG)
Immediate start of extended reality exercise program for 36 weeks.
|
Seated arm exercise using an extended reality headset for 36 weeks.
|
|
Sem intervenção: Non-intervention Control
Continue habitual activities for 36 weeks.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Godin Leisure Time Exercise Questionnaire
Prazo: 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.
|
week 0, week 6, week 12, week 24, week 36
|
|
Daily Step Count
Prazo: weeks 0-36
|
Steps per day, captured using the Polar Unite wrist watch.
|
weeks 0-36
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Changes in C-reactive Protein (hsCRP)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
|
Week 0, Week 6, Week 12, Week 24, Week 36
|
|
Timed Up and Go (TUG)
Prazo: 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.
|
Week 0, Week 6, Week 12, Week 24, Week 36
|
|
Hand-grip Strength Test (hand-held dynamometer)
Prazo: 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
|
|
NIH PROMIS Global Health Pediatric (7 item) survey
Prazo: 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
|
|
Changes in Body Weight
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Byron Lai, MS, PhD, University of Alabama at Birmingham
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de dezembro de 2026
Conclusão Primária (Estimado)
9 de março de 2031
Conclusão do estudo (Estimado)
31 de maio de 2031
Datas de inscrição no estudo
Enviado pela primeira vez
27 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de abril de 2026
Primeira postagem (Real)
4 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB-300016599
- UAB (Outro identificador: UAB)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
All collected IPD.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .