- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Demande
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Saint-Maurice, Demande, Francia, 94410
- Hôpitaux Paris Est Val-de-Marne - Centre de Référence des Malformations des Membres
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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.
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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%.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Expert Consensus on VESAQ Questionnaire Items
Periodo de tiempo: Through completion of the three-round Delphi process, approximately 7 months
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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.
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Through completion of the three-round Delphi process, approximately 7 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Romane RP PIAUD, Institut Merle d'Aubigné
- Silla de estudio: Mathilde MC CARET, Hôpitaux Paris Est Val-de-Marne (HPEVM)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- VESAQ
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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