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

NCT07782645 | Completed

• 1 other identifier: VESAQ
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Limb Amputation

Keywords

Pediatric Limb Amputatio,; Sports Participation; Physical Activity; VESAQ; Questionnaire; Content Validity; Delphi Method; Expert Consensus

Outcome Measures

Primary Outcomes (1)

• Expert Consensus on VESAQ Questionnaire Items

  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

Study Arms (1)

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.

Other: Three-Round Delphi Process

Interventions

Three-Round Delphi Process OTHER

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%.

Multidisciplinary Expert Panel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult experts with professional or experiential expertise relevant to pediatric limb amputation, rehabilitation, prosthetic management, and adapted physical activity. Participants were recruited to form a multidisciplinary expert panel for the content validation of the VESAQ questionnaire using a three-round Delphi process.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopitaux de Saint-Maurice: lead

Study Sites (1)

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

Saint-Maurice, Demande, 94410, France

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Romane RP PIAUD

  Institut Merle d'Aubigné

  PRINCIPAL INVESTIGATOR

• Mathilde MC CARET

  Hôpitaux Paris Est Val-de-Marne (HPEVM)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start: September 28, 2025
• Primary Completion: April 9, 2026
• Study Completion: April 9, 2026
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)