- ICH GCP
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- Klinische proef NCT06924801
Integratie van real-time motion tracking en pediatrische revalidatie: een prospectieve, cohortstudie (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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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California
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Palo Alto, California, Verenigde Staten, 94304
- Lucile Packard Children's Hospital Stanford
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Evaluate the ease of use of Optitrack system measured by System Usability Scale (SUS)
Tijdsspanne: Post-simulation (5 minutes)]
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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)]
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Acceptability of Intervention Measure (AIM) survey
Tijdsspanne: 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
|
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Intervention Appropriateness Measure (IAM) survey
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
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Setup time required for system use
Tijdsspanne: 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
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Duration of gameplay-driven physical activity
Tijdsspanne: immediately at the start of intervention, immediately after intervention
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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
|
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Evaluation parent's perception of patient's engagement.
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 80334
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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