- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT06924801
Integration von Echtzeit-Bewegungsverfolgung und pädiatrischer Rehabilitation: Eine prospektive Kohortenstudie (Snipperfinger)
Emerging technologies that utilize motion capture integrated with engaging software offer new methods for increasing engagement and movement in patients admitted to the hospital. Hospitalized patients are often limited to sedentary activities, spending the majority of their time in bed, which can contribute to deconditioning and functional mobility deficits. This study seeks to explore the feasibility of a tool designed to promote movement through engaging gameplay that is acceptable to both clinicians and families.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
California
-
Palo Alto, California, Vereinigte Staaten, 94304
- Lucile Packard Children's Hospital Stanford
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Pediatric patients aged 6-17 years.
- Receiving physical therapy at Stanford Children's Hospital.
- Medically cleared for standing and upper-body movement.
- Ability to follow simple instructions and engage in standing gameplay
Exclusion Criteria:
- Orthopedic or medical conditions contraindicating physical activity.
- Legal guardian not present to obtain consent
- Child with a significant neurological condition or major developmental disability
- Child with active infection of the face or hand
- A history of severe motion sickness A history of seizures caused by flashing light Major surgery within the last 48 hours
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Pediatric patient
Pediatric patient will engage with engagement-focused software platform (Snipperfingers) and movement will be analysed by the real-time motion capture system (the OptiTrack system). |
Snipperfinger is a self developed engagement focused software platform designed to encourage participation in pediatric physical therapy. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Evaluate the ease of use of Optitrack system measured by System Usability Scale (SUS)
Zeitfenster: Post-simulation (5 minutes)]
|
10-item questionnaire with a scale from 1- 5, 1 being strongly disagree to 5 being strongly agree on a five-point Likert scale to measure usability. |
Post-simulation (5 minutes)]
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Acceptability of Intervention Measure (AIM) survey
Zeitfenster: immediately after the intervention
|
This questionnaire consists of 4 items. Measures are to be graded using a 1-5 scale, from 1=completely disagree, to 5= completely agree |
immediately after the intervention
|
|
Intervention Appropriateness Measure (IAM) survey
Zeitfenster: immediately after the intervention
|
This questionnaire consists of 4 items. Measures are to be graded using a 1-5 scale, from 1=completely disagree, to 5= completely agree |
immediately after the intervention
|
|
Feasibility of Intervention Measure (FIM) survey
Zeitfenster: immediately after the intervention
|
This questionnaire consists of 4 items. Measures are to be graded using a 1-5 scale, from 1=completely disagree, to 5= completely agree |
immediately after the intervention
|
|
ISO 9241-400
Zeitfenster: immediately after intervention
|
6-item ergonomic questionnaire with a scale from 1- 5, 1 being strongly disagree to 5 being strongly agree on a five-point Likert scale. |
immediately after intervention
|
|
Setup time required for system use
Zeitfenster: Before intervention
|
Time required to set up the system, defined as the duration from participant arrival in the gym to the start of the physical activity. |
Before intervention
|
|
Duration of gameplay-driven physical activity
Zeitfenster: immediately at the start of intervention, immediately after intervention
|
Time from first recorded movement in response to gameplay to last movement as recorded by OptiTrack motion capture or clinician observation |
immediately at the start of intervention, immediately after intervention
|
|
Evaluation parent's perception of patient's engagement.
Zeitfenster: immediately after intervention
|
Parent acceptance of the system will be evaluated by self developed questionnaire. The questionnaire contains 10 items with scale from 1-5, 1 being strongly disagree to 5 being strongly agree on a five-point Likert scale. |
immediately after intervention
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 80334
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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