- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07782645
Content Validation of a Questionnaire on Sports Activities in Children With Limb Amputation (VESAQ)
Content Validation of the VESAQ Questionnaire on Sports Activities in Children With Limb Amputation Using a Delphi Method
The VESAQ study aims to validate the content of a questionnaire designed to assess sports participation in children with limb amputation. Content validation was conducted using a three-round Delphi method involving a multidisciplinary panel of adult experts with professional or experiential expertise relevant to pediatric limb amputation, rehabilitation, prosthetic management, and adapted physical activity.
Children with limb amputation are the future target population of the questionnaire but did not participate in this content-validation study, and no individual medical data from pediatric patients were collected.
The Delphi process aimed to establish expert consensus on the relevance and clarity of the questionnaire content and to produce a final consensual version of the VESAQ.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The VESAQ (Questionnaire on Sports Activities in Children With Limb Amputation) was developed to provide a structured and multidimensional tool for assessing sports participation in children with limb amputation. The questionnaire addresses dimensions related to limb amputation, prosthetic devices when applicable, sports participation, functional limitations, barriers and facilitators, family, school and sports environments, the child's experience, and the support provided.
Content validation was conducted using a three-round Delphi process involving a multidisciplinary panel of adult experts with relevant professional or experiential expertise in the field of pediatric limb amputation, rehabilitation, prosthetic management, and adapted physical activity.
During the successive Delphi rounds, participants assessed proposed domains and questionnaire items using Likert scales and could provide qualitative comments and suggestions for reformulation. Following each round, responses were analyzed and the questionnaire was progressively revised to improve the clarity, relevance, and organization of its items.
Consensus was predefined as a median score of at least 4, an interquartile range of 1 or less, and an agreement rate of at least 70%. The first Delphi round focused on the main questionnaire domains, the second round evaluated the proposed items in greater detail, and the third round aimed to stabilize consensus and finalize the questionnaire.
A total of 26 experts were included in the study, of whom 23 participated through the end of the third Delphi round. Children with limb amputation did not participate in this content-validation study, and no individual medical data from pediatric patients were collected.
The objective of the study is to establish a final consensual version of the VESAQ based on the Delphi results. This content-validation phase is intended as a methodological step before subsequent studies evaluating the psychometric properties of the questionnaire, including its validity, reliability, reproducibility, and responsiveness to change.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Demande
-
Saint-Maurice, Demande, Francia, 94410
- Hôpitaux Paris Est Val-de-Marne - Centre de Référence des Malformations des Membres
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Healthcare professionals or other specialists involved in the care or support of children with limb amputation, including physical and rehabilitation medicine physicians, physiotherapists, prosthetists and orthotists, occupational therapists, adapted physical activity professionals, and sports educators.
- Patient experts.
- At least one year of experience in the field of pediatrics, limb amputation, and/or prosthetic management.
- Willingness to participate in the Delphi process and to provide informed consent and agree to confidentiality requirements
Exclusion Criteria:
- Refusal or withdrawal of consent for the use of study data.
- Non-participation in the Delphi rounds or prolonged disengagement from the Delphi process.
- Conflict of interest related to the validation of the questionnaire, including authorship of the VESAQ or commercial involvement.
- Minors.
- Individuals under legal protection or unable to provide informed consent.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Multidisciplinary Expert Panel
Adult experts with professional or experiential expertise relevant to pediatric limb amputation, rehabilitation, prosthetic management, and adapted physical activity participated in a three-round Delphi process to assess the relevance and clarity of the VESAQ questionnaire content and establish expert consensus.
|
Participants completed three successive Delphi rounds to evaluate the domains and items of the VESAQ questionnaire.
Items were rated using Likert scales for relevance and clarity, with the possibility of providing qualitative comments and suggestions for reformulation.
After each round, responses were analyzed using predefined consensus criteria, and the questionnaire was progressively revised.
Consensus was defined as a median score of at least 4, an interquartile range of 1 or less, and an agreement rate of at least 70%.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Expert Consensus on VESAQ Questionnaire Items
Lasso di tempo: Through completion of the three-round Delphi process, approximately 7 months
|
Expert consensus on the content of the VESAQ questionnaire, assessed using Likert-scale ratings.
Consensus for an item was defined as a median rating of at least 4, an interquartile range of 1 or less, and an agreement rate of at least 70%, with agreement defined as the proportion of ratings of 4 or higher.
|
Through completion of the three-round Delphi process, approximately 7 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Romane RP PIAUD, Institut Merle d'Aubigné
- Cattedra di studio: Mathilde MC CARET, Hôpitaux Paris Est Val-de-Marne (HPEVM)
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- VESAQ
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .