Content Validation of a Questionnaire on Sports Activities in Children With Limb Amputation | NCT07782645 | Trialant

CompletedObservationalUpdated Aug 24, 2026

Content Validation of a Questionnaire on Sports Activities in Children With Limb Amputation

Content Validation of the VESAQ Questionnaire on Sports Activities in Children With Limb Amputation Using a Delphi Method

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07782645
Lead Sponsor: Hopitaux de Saint-MauriceOTHER
Overall Status: Completed
Study Type: Observational
Enrollment: 26Actual
Last Update Posted: Aug 24, 2026Actual
Start Date: Sep 28, 2025Actual
Primary Completion Date: Apr 9, 2026Actual
Completion Date: Apr 9, 2026Actual

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Content Validation of the VESAQ Questionnaire on Sports Activities in Children With Limb Amputation Using a Delphi Method
Brief Summary: 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.
Detailed Description

Conditions

The medical conditions and diseases this study investigates.

Limb Amputation

Interventions

The treatments and procedures being evaluated in this study.

Three-Round Delphi Process

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Eligibility Criteria: 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.

Design

How the study is designed and how its participant groups are organized.

Observational Model: Other
Time Perspective: Prospective

Contacts

The people to reach with questions about this study or how to join it.

No central contacts

There are no central contacts for this study.

Locations

Where the study is run and whether each site is currently recruiting.

Hôpitaux Paris Est Val-de-Marne - Centre de Référence des Malformations des Membres

Saint-Maurice, Demande 94410, France

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Hopitaux de Saint-MauriceOTHER

Similar Studies

Other registered studies that closely resemble this one.

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.