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Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy (REACT)

4. november 2026 opdateret af: Julie Robillard, University of British Columbia

Robotic Engagement for Active Children's Therapy (REACT): NAO Cerebral Palsy Intervention

Cerebral palsy can make it difficult for children and adolescents to participate consistently in enjoyable physical activity. This study will examine whether a small humanoid robot called NAO can deliver a short, story-based active-play session that encourages movement and participation. Children and adolescents with cerebral palsy will complete one session at BC Children's Hospital. The study will assess whether the intervention is practical to deliver, acceptable to children and caregivers, and safe to use. Participants and caregivers will also provide feedback about their experience. The findings will be used to refine the intervention and plan a future larger trial.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Ikke rekrutterer endnu

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

This is a single-session, single-arm, mixed-methods feasibility and acceptability study of a humanoid social robot-delivered, movement-based narrative active-play intervention for children and adolescents with cerebral palsy. The intervention is delivered by the NAO humanoid robot and is structured as a guided story in which the participant and robot move together through a sequence of physical actions. The intervention is designed around engagement and active participation rather than conventional prescriptive exercise delivery.

Participants across Gross Motor Function Classification System (GMFCS) Levels I-IV will complete an in-person session at BC Children's Hospital. The protocol includes parallel ambulatory and non-ambulatory versions that share a common narrative structure and movement library. During the session, behavioural, physiological, and movement-related information will be collected to characterize participant engagement and physical activity. Following the intervention, children or adolescents and their caregivers will complete measures related to engagement, exertion, comfort, acceptability, willingness to participate in the future, and their experience of the intervention. Semi-structured exit interviews will also be conducted.

The primary purpose of the study is to determine the feasibility and acceptability of delivering the intervention. Feasibility will be characterized using indicators including recruitment and consent, session completion, intervention fidelity, protocol deviations, adverse events, and measurement-protocol completeness. Qualitative feedback will be used to identify barriers, facilitators, and potential modifications to the intervention and study procedures.

The study is not designed or powered to evaluate intervention efficacy. Findings will instead be used to refine the intervention, study procedures, and outcome measures and to inform the design of a future definitive randomized controlled trial.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
40

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Undersøgelse Kontakt Backup

Studiesteder

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • BC Children's Hospital
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Julie Robillard, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

6 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Children & adolescents -

  • Aged 6-18 years with cerebral palsy
  • Gross Motor Function Classification System (GMFCS) Level I-IV
  • Sufficient receptive English language ability to follow simple verbal instructions from NAO and respond to interview questions, with or without caregiver or communication-aid support

Parent/caregiver -

  • Aged 19 years or older
  • Sufficient receptive English language ability to participate in interview and survey questions

Additional participation requirements -

  • Able to attend an in-person study visit at BC Children's Hospital
  • Enrollment is at the dyad level: each child/adolescent must participate with a parent/caregiver, and neither may participate independently

Exclusion Criteria:

  • GMFCS Level V
  • Uncontrolled seizure disorder or seizure within the previous 6 months
  • Severe visual or auditory impairment uncorrected by aids that would prevent interaction with NAO
  • Significant cognitive or communication impairment precluding assent and interview participation
  • Acute illness or cardiovascular condition contraindicating light-to-moderate physical activity

Additional consideration:

- Individuals will be encouraged not to participate if the child or caregiver reports a fear of robots

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: NAO-Guided Active Play Intervention

Participants will complete one in-person, NAO-delivered, movement-based narrative active-play session. The intervention includes parallel ambulatory (GMFCS I-III) and non-ambulatory (GMFCS IV) versions, with both versions sharing a common narrative structure and movement library.
Adfærdsmæssigt: Humanoid Robot-Guided Active Play Intervention

A humanoid social robot (NAO, SoftBank Robotics) guides the participant through a single, story-based active-play session in which physical movements are embedded within a narrative. The intervention is designed to promote engagement and active participation rather than conventional prescriptive exercise delivery. Parallel ambulatory (GMFCS I-III) and non-ambulatory (GMFCS IV) versions are used, with both sharing a common narrative structure and movement library.

Andre navne:
  • REACT

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recruitment Rate
Tidsramme: From recruitment initiation through completion of enrollment, anticipated up to 15 months

Number of child/adolescent participants enrolled relative to the prespecified recruitment target. Recruitment will be summarized descriptively. Progression will be interpreted as: target achieved = proceed; below target but recruitment achievable with an adjusted strategy or timeline = proceed with modification; below target with no feasible recruitment pathway = reconsider.
From recruitment initiation through completion of enrollment, anticipated up to 15 months
Consent Rate
Tidsramme: From recruitment initiation through completion of enrollment, anticipated up to 15 months

Percentage of eligible child-caregiver dyads invited to participate who provide caregiver consent and child/adolescent assent and enroll in the study. Prespecified progression thresholds are ≥80% = proceed; 60-79% = proceed with modification; <60% = reconsider.
From recruitment initiation through completion of enrollment, anticipated up to 15 months
Session Completion Rate
Tidsramme: At completion of the approximately 12-minute intervention during the single study visit

Percentage of enrolled child/adolescent participants who complete the planned NAO-guided active-play intervention session. Prespecified progression thresholds are ≥80% = proceed; 60-79% = proceed with modification; <60% = reconsider.
At completion of the approximately 12-minute intervention during the single study visit
Intervention Fidelity
Tidsramme: At completion of the approximately 12-minute intervention during the single study visit

Fidelity to the prespecified NAO-guided intervention protocol will be assessed using the approved intervention fidelity checklist and summarized as a percentage. Prespecified progression thresholds are ≥80% = proceed; 60-79% = proceed with modification; <60% = reconsider.
At completion of the approximately 12-minute intervention during the single study visit

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Protocol Deviations
Tidsramme: At completion of the approximately 90-minute study visit (Day 1), based on deviations recorded throughout the visit

Number and nature of protocol deviations occurring during study participation, recorded using the approved protocol deviation and adverse event log and summarized descriptively.
At completion of the approximately 90-minute study visit (Day 1), based on deviations recorded throughout the visit
Adverse Events
Tidsramme: From enrollment through completion of the single study visit, approximately 90 minutes

Number and nature of adverse events occurring during study participation, recorded using the approved protocol deviation and adverse event log and summarized descriptively.
From enrollment through completion of the single study visit, approximately 90 minutes
REACT Post-Narrative Intervention Likert Scale: Child/Adolescent Engagement and Intention to Repeat
Tidsramme: Immediately following the intervention during the single study visit

Child/adolescent engagement and intention to repeat the activity will be assessed using the age-appropriate REACT Post-Narrative Intervention Likert Scale (child version, ages 6-13; adolescent version, ages 14-18). Each version contains five items assessing enjoyment, desire to continue the activity, ease of performing the movements, experience interacting with NAO, and willingness to participate in a similar session again. Each item is rated from 1 to 5, with higher scores indicating a more positive response on that item. Responses will be summarized descriptively at the item level; no composite or total score will be calculated.
Immediately following the intervention during the single study visit
REACT Caregiver Acceptability and Willingness Survey
Tidsramme: Immediately following the intervention during the single study visit

Caregiver acceptability and willingness will be assessed using the purpose-built REACT Caregiver Acceptability and Willingness Survey. The survey contains 10 Likert items assessing perceived child enjoyment, engagement, comfort and safety, overall experience, willingness to participate again, willingness to participate in a longer program, comfort with use in therapy or at home, and willingness to recommend the session to other families. Each item is rated from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater agreement and a more positive response on that item. Responses will be summarized descriptively at the item level; no composite or total score will be calculated.
Immediately following the intervention during the single study visit
Participant-Reported Session Length and Sensor Comfort via REACT Facilitator Interview Guide
Tidsramme: During the approximately 30-minute post-intervention interview conducted during the single study visit

Child/adolescent perceptions of intervention length and comfort while wearing the arm-strap heart-rate monitor and wrist-worn accelerometer will be assessed using purpose-built questions and prompts in the REACT Facilitator Interview Guide. Participants will be asked whether the activity felt too long, too short, or appropriate in length and whether the study sensors caused discomfort or were noticeable during participation. Responses will be analyzed qualitatively; no numerical scale or composite score will be calculated.
During the approximately 30-minute post-intervention interview conducted during the single study visit
Participant and Caregiver Qualitative Experience
Tidsramme: Immediately following the intervention; approximately 30-minute interview during the single study visit

A semi-structured dyadic interview with the child/adolescent and caregiver will explore their experience of the NAO-guided active-play intervention, including perceived acceptability, what worked or did not work, barriers and facilitators to participation, and recommended refinements to the intervention and study procedures.
Immediately following the intervention; approximately 30-minute interview during the single study visit

Andre resultatmål

Andre resultatmål

For kliniske forsøg en planlagt måling beskrevet i protokollen, der bruges til at bestemme effekten af ​​en intervention/behandling på deltagerne. Til observationsstudier, en måling eller observation, der bruges til at beskrive mønstre af sygdomme eller egenskaber eller sammenhænge med eksponeringer, risikofaktorer eller behandling. Typer af resultatmål omfatter primært resultatmål og sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
OMNI Rating of Perceived Exertion Scale: Perceived Exertion
Tidsramme: Immediately following the approximately 12-minute intervention

Child/adolescent perceived exertion will be assessed using the cerebral palsy-specific OMNI Rating of Perceived Exertion scale, with ambulatory and non-ambulatory pictorial versions used as appropriate. The scale ranges from 0 ("not tired at all") to 10 ("very, very tired"), with higher scores indicating greater perceived exertion. Higher scores do not inherently represent a better or worse outcome.
Immediately following the approximately 12-minute intervention
Heart Rate Response
Tidsramme: During a 2-minute resting baseline and the approximately 12-minute intervention

Heart rate will be recorded using an arm-strap heart rate monitor during a seated resting baseline and the NAO-guided active-play intervention. Heart rate data will be summarized descriptively to characterize physiological response during participation.
During a 2-minute resting baseline and the approximately 12-minute intervention
Accelerometer-Derived Movement Output
Tidsramme: During the 2-minute seated resting baseline and the approximately 12-minute NAO-guided intervention during the single study visit

Movement data will be collected using a wrist-worn accelerometer and summarized descriptively to characterize movement and physical activity during the NAO-guided active-play intervention.
During the 2-minute seated resting baseline and the approximately 12-minute NAO-guided intervention during the single study visit
Sensor Wear Time
Tidsramme: From sensor placement before the 2-minute resting baseline through sensor removal immediately following the approximately 12-minute NAO-guided intervention during the single study visit.

Wear time for the arm-strap heart-rate monitor and wrist-worn accelerometer will be recorded in minutes from initial sensor placement to removal. Wear time will be summarized descriptively for each sensor separately; no combined wear-time score will be calculated.
From sensor placement before the 2-minute resting baseline through sensor removal immediately following the approximately 12-minute NAO-guided intervention during the single study visit.
Sensor Device-Removal Events
Tidsramme: From sensor placement before the 2-minute resting baseline through completion of the approximately 12-minute NAO-guided intervention during the single study visit

The number of heart-rate monitor and accelerometer removal events occurring during the planned sensor-wear period will be recorded and summarized descriptively as counts. Events will be reported by sensor type.
From sensor placement before the 2-minute resting baseline through completion of the approximately 12-minute NAO-guided intervention during the single study visit
Per-Instrument Sensor Data Completeness
Tidsramme: From the 2-minute resting baseline through completion of the approximately 12-minute NAO-guided intervention during the single study visit

Data completeness will be assessed separately for the arm-strap heart-rate monitor and wrist-worn accelerometer as the percentage of the planned recording period for which sensor data are available. Higher percentages indicate greater data completeness. Heart-rate and accelerometer completeness will be reported separately; no combined score will be calculated.
From the 2-minute resting baseline through completion of the approximately 12-minute NAO-guided intervention during the single study visit
Behavioural Engagement Assessed Using a Study-Specific Structured Video Coding Protocol
Tidsramme: During the approximately 12-minute NAO-guided intervention during the single study visit (Day 1)

Behavioural engagement during the NAO-guided intervention will be assessed from video recordings using a study-specific structured coding protocol developed and piloted by two independent coders. Behavioural engagement codes will be summarized descriptively; no standardized scale or composite score will be calculated. Inter-rater reliability will be established on a minimum of 20% of recordings, with a target Cohen's κ ≥0.70 before full coding.
During the approximately 12-minute NAO-guided intervention during the single study visit (Day 1)
Movement Quality Assessed Using a Study-Specific Structured Video Coding Protocol
Tidsramme: During the approximately 12-minute NAO-guided intervention during the single study visit (Day 1)

Movement quality during the NAO-guided intervention will be assessed from video recordings using a study-specific structured coding protocol developed and piloted by two independent coders. Movement-quality codes will be summarized descriptively; no standardized scale or composite score will be calculated. Inter-rater reliability will be established on a minimum of 20% of recordings, with a target Cohen's κ ≥0.70 before full coding.
During the approximately 12-minute NAO-guided intervention during the single study visit (Day 1)
Critical Incidents Assessed Using a Study-Specific Structured Video Coding Protocol
Tidsramme: During the approximately 12-minute NAO-guided intervention during the single study visit (Day 1)

Critical incidents occurring during the NAO-guided intervention will be identified from video recordings using a study-specific structured coding protocol developed and piloted by two independent coders. Critical-incident codes will be summarized descriptively; no standardized scale or composite score will be calculated. Inter-rater reliability will be established on a minimum of 20% of recordings, with a target Cohen's κ ≥0.70 before full coding.
During the approximately 12-minute NAO-guided intervention during the single study visit (Day 1)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
University of British Columbia

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Julie Robillard, PhD, University of British Columbia

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
15. november 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. december 2027

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
1. december 2027

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
14. september 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
21. september 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
25. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
6. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
4. november 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • H26-01002

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be made available to external researchers. Study data will be de-identified and stored securely on UBC OneDrive, with access limited to the research team, and retained for five years after publication in accordance with the approved ethics protocol.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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