The Injury and Its Consequences in the Sports Lower Limb... | NCT05059886

Studies
The Injury and Its Consequences in the Sports Lower Limb Amputee

NCT05059886

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Oct 27, 2022Actual

Enrollment

45Actual

Phase

Not provided

Conditions

Leg Lower Amputation
Traumatic Amputation

Interventions

completion of a questionnaire on the practice of sports and possible injuries

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2021-A01657-34	Registry Identifier	ID-RCB (ANSM)

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 11, 2022Actual

Primary Completion Date

Jun 16, 2022Actual

Completion Date

Jun 16, 2022Actual

First Submitted Date

Sep 17, 2021

First Submission Date that Met QC Criteria

Sep 27, 2021

First Posted Date

Sep 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2022

Last Update Posted Date

Oct 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study was motivated by the lack of data in the literature on the injury of the major lower limb amputee playing sports and its socio-professional impact.

It aims to study sports-related injuries in lower limb amputees. Its objective is to determine the prevalence, but also to describe the injuries (type, location, duration, type of management) and their repercussions in terms of after-effects, and repercussions on sports, professional and personal practice. It also aims to begin a correlation between injury and sports load, type of sport (discipline, practice modality), technical aids used

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lower limb amputee		No intervention, pure observational study	Other: completion of a questionnaire on the practice of sports and possible injuries

Interventions

Name	Type	Description	Arm Group Labels	Other Names
completion of a questionnaire on the practice of sports and possible injuries	Other	completion of a questionnaire on the practice of sports and possible injuries	lower limb amputee

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prevalence of injuries	presence of injuries (Yes/No, if yes, Nb)	in the 5 years preceding the completion of the questionnaire

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Lower limb amputee or lower limb agenes
Amputee before 55 years old
Amputee for more than 2 years
Willing to participate in the study
Practicing a regular physical activity (at least 1x/week)
Patient affiliated or beneficiary of a health insurance plan.
Patient aged 18-65 years

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Lower limb amputee or agenic lower limb with regular physical activity (at least 1x/week)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anissa MEGZARI	Centre Hospitalier Universitaire de Nīmes	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nîmes		Nîmes		30029	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided