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CompletedNCT07782645VESAQUpdated Aug 24, 2026

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

An observational study in Limb Amputation, sponsored by Hopitaux de Saint-Maurice. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Hopitaux de Saint-Maurice · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
26
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 367 studies in Motor Activity with a site in France — 78 open to participants now, 90 under way, none of them phase 3. Motor Activity · France.

Enrollment
80th of 98
26 · median 98
Started
2025
with 26 others
Observational
98 of 367
25 open now
Registered
361st of 367
by date

Among the 367 studies in Motor Activity with a site in France, this one is the 80th largest by enrollment of the 98 observational ones that give a count, is one of 27 that started in 2025, is one of 98 observational ones, and was the 361st registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

78 of the 367 studies in Motor Activity with a site in France are open now. Recruiting first, the newest first:

73 more — sign in →

All 78 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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02

Study 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.

Read the detailed description

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.

03

Conditions studied

  • Limb Amputation

Browse trials for

Keywords

  • Pediatric Limb Amputatio,
  • Sports Participation
  • Physical Activity
  • VESAQ
  • Questionnaire
  • Content Validity
  • Delphi Method
  • Expert Consensus
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and agree to confidentiality requirements

Exclusion criteria

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 .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
26 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherThree-Round Delphi Process

    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%.

06

What researchers measure

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.

    Time frame: Through completion of the three-round Delphi process, approximately 7 months

07

Study locations

1 site
  • Hôpitaux Paris Est Val-de-Marne - Centre de Référence des Malformations des Membres
    Saint-Maurice, Demande 94410, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2025 to primary completion in Apr 2026, 6 months.

Of 490 non-industry observational studies under Motor Activity, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 48. This study's 6 months is below that.

Counting every sponsor, half of 500 studies reached it within 22 months; a quarter within 8 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2026
First posted
Aug 24, 2026
StartActual
Sep 28, 2025
Primary completionActual
Apr 9, 2026
CompletionActual
Apr 9, 2026
Last update
Aug 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07782645
Lead sponsor
Hopitaux de Saint-Maurice
Responsible party
Sponsor
First posted
Aug 24, 2026
Start date
Sep 28, 2025
Primary completion
Apr 9, 2026
Completion
Apr 9, 2026
Last update
Aug 24, 2026

Study contacts

Romane RP PIAUD
principal investigator · Institut Merle d'Aubigné
Mathilde MC CARET
study chair · Hôpitaux Paris Est Val-de-Marne (HPEVM)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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