Leg Lower AmputationPREV'AMP SPORTNCT05059886
The Injury and Its Consequences in the Sports Lower Limb Amputee
An observational study of Leg Lower Amputation and Traumatic Amputation, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Leg Lower Amputation, Traumatic Amputation
- What is being tested?
- completion of a questionnaire on the practice of sports and possible injuries
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2022to 16 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lower limb amputee or agenic lower limb with regular physical activity (at least 1x/week)
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Leg Lower Amputation, Traumatic Amputation
- Being tested
- completion of a questionnaire on the practice of sports and possible injuries
- Keywords
- sport, lower limb amputation
- Medical subject headings
- Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
completion of a questionnaire on the practice of sports and possible injuriesOther
completion of a questionnaire on the practice of sports and possible injuries
| Study group | Role | What they receive |
|---|---|---|
| lower limb amputee | No intervention, pure observational study Receives: Other: completion of a questionnaire on the practice of sports and possible injuries |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of injuries
presence of injuries (Yes/No, if yes, Nb)
Measured: in the 5 years preceding the completion of the questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start11 Jan 2022
- Primary completion16 Jun 2022
- Study completion16 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg Lower AmputationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anissa MEGZARI, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059886
- Sponsor's protocol ID
- Local/2021/GM-01
- Other IDs
- 2021-A01657-34
- Acronym
- PREV'AMP SPORT
- Status last verified
- Oct 2022
- First submitted
- 17 Sep 2021
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Injury and Its Consequences in the Sports Lower Limb Amputee
- ClinicalTrials.gov ID
- NCT05059886
- Acronym / sponsor ID
- PREV'AMP SPORT / Local/2021/GM-01
- Conditions
- Leg Lower Amputation, Traumatic Amputation
- Keywords
- sport, lower limb amputation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lower limb amputee | – | Other: completion of a questionnaire on the practice of sports and possible injuriesNo intervention, pure observational study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lower limb amputee or agenic lower limb with regular physical activity (at least 1x/week)
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| completion of a questionnaire on the practice of sports and possible injuriescompletion of a questionnaire on the practice of sports and possible injuries | Other | lower limb amputee |
Primary outcome
prevalence of injuries
Time frame: in the 5 years preceding the completion of the questionnaire
presence of injuries (Yes/No, if yes, Nb)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anissa MEGZARI study director
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leg Lower Amputation and Traumatic Amputation, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of injuries (time frame: in the 5 years preceding the completion of the questionnaire). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.