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Leveraging Extended Reality Exergaming and Telehealth to Improve Physical Activity and Health in Children With Disabilities

11. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

130

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Byron Lai, MS, PhD
  • Telefonnummer: 89725 205-638-9790
  • E-Mail: blai@uabmc.edu

Studienorte

  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35233
        • University of Alabama at Birmingham
        • Kontakt:
          • Byron Lai, MS, PhD
          • Telefonnummer: 89725 205-638-9790
          • E-Mail: blai@uabmc.edu
      • Birmingham, Alabama, Vereinigte Staaten, 32533
        • Children's of Alabama
        • Kontakt:
          • Byron Lai, MS, PhD
          • Telefonnummer: 89725 205-638-9790
          • E-Mail: blai@uabmc.edu

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  1. medical diagnosis of cerebral palsy
  2. 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)
  3. physician clearance to participate in moderate-intensity exercise
  4. access to a Wi-Fi Internet connection in the home
  5. 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:

  1. physically active (defined as ≥150 minutes per week of moderate-to-vigorous intensity exercise in a typical week)
  2. prone to photosensitive seizures
  3. a classification of GMFCS level V, which we have found to preclude the ability to use the Oculus Quest hand-held controllers
  4. complete blindness or deafness
  5. unable to communicate in English (participant and caregiver)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Extended Reality Gaming (XRG)
Immediate start of extended reality exercise program for 36 weeks.
Verhalten: Extended Reality Exergaming
Seated arm exercise using an extended reality headset for 36 weeks.
Kein Eingriff: Non-intervention Control
Continue habitual activities for 36 weeks.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Godin Leisure Time Exercise Questionnaire
Zeitfenster: 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
Zeitfenster: weeks 0-36
Steps per day, captured using the Polar Unite wrist watch.
weeks 0-36

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in C-reactive Protein (hsCRP)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Alabama at Birmingham

Ermittler

  • Hauptermittler: Byron Lai, MS, PhD, University of Alabama at Birmingham

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Dezember 2026

Primärer Abschluss (Geschätzt)

9. März 2031

Studienabschluss (Geschätzt)

31. Mai 2031

Studienanmeldedaten

Zuerst eingereicht

27. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. April 2026

Zuerst gepostet (Tatsächlich)

4. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB-300016599
  • UAB (Andere Kennung: UAB)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

All collected IPD.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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