AmputationNCT05778799
Physical Activity and Sports for People With Special Needs
An observational study of Amputation and Dysmelia, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
Trial summary
Purpose of this study was to assess the balance level of highly qualified amputee football players in relation to their sports level, training experience, position on the pitch, as well as the type of amputation/dysfunction and disability experience. Read more about this study
- Who is it for?
- Ages 16 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Amputation, Dysmelia, Leg; Deformity, Congenital
- What is being tested?
- Balance test
- How many people
- 66 participants
- Where
- 1 sitePoland
- Study dates
- 11 Sep 2021to 19 Sep 2021
- 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 16 years and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Members of 14 teams, field players with lower limb impairment participating in European Amputee Football Championship.
Who may be able to join
- participant of European Amputte Football Championschip
- field player (leg amputation or leg dysfunction)
- written consent form
Who cannot join
- goalkeeper
- injury
- tiredness
- refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Balance Assessment of People With Lower Limb Impairment Practicing Amputee Football
Purpose of this study was to assess the balance level of highly qualified amputee football players in relation to their sports level, training experience, position on the pitch, as well as the type of amputation/dysfunction and disability experience.
Read the detailed description
The participants were presented with the procedure of the study and informed that they could resign from their participation in the study at any stage. All participants were given the written informed consent form after the detailed written and oral explanation of the risk and benefits resulting from participation in this study Static balance was assessed using AMTI AccuSway stabilographic platform (ACS Model). The study participants performed the single 10 second left- or right-leg stance with eyes open (EO), and single 10 second left- or right-leg stance with eyes closed (EC) (depending on leg amputation). If the first attempt was not successful, study participants were able to do the second attempt. The tests were conducted on a match-free day, approximately 2 hours after a meal, in a sports outfit, in a specially designated room.
- Conditions
- Amputation, Dysmelia, Leg; Deformity, Congenital
- Being tested
- Balance test
- Keywords
- Amputation, Amputee Football, Performance, Balance
- Medical subject headings
- Lower Extremity Deformities, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance testOther
10 second left- or right-leg stance with eyes open, and single 10 second left- or right-leg stance with eyes closed
What is being measured
The primary outcome is the main question the study is designed to answer.
Center of pressure (CoP) path lenght was measured
CoP displacement analysis is used to assess postural sway, based on which the balance control function can be assessed
Measured: Baseline
Surface area of stabilogram was mesured
Based on the analysis of the surface area of the stabilogram, the level of balance control can be assessed
Measured: Baseline
Visual inspection indicator (VII) was measured
VII aggregates surface areas of stabilograms (cm2) with eyes open and closed. In theory, maximum value of the indicator may come to 100%. As a rule, it is positive, which means that the surface area of the stabilogram increases with eyes closed. The indicator is higher when the difference between the surface area of the stabilogram in the test with eyes closed and the surface area of the stabilogram in the test with eyes open is greater. Lower values of the VII may indicate a reduced role of visual control in maintaining balance or the lack of its compensation.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start11 Sep 2021
- Primary completion19 Sep 2021
- Study completion19 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Józef Piłsudski University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jolanta Marszałek, PhD, Study director, University of Physical Education in Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778799
- Sponsor's protocol ID
- Research Group no 4
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2023
- Last updated
- 31 Mar 2023
- 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 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance Assessment of People With Lower Limb Impairment Practicing Amputee Football
- ClinicalTrials.gov ID
- NCT05778799
- Acronym / sponsor ID
- Research Group no 4
- Conditions
- Amputation, Dysmelia, Leg; Deformity, Congenital
- Keywords
- Amputation, Amputee Football, Performance, Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Józef Piłsudski University of Physical EducationUniversity, hospital or other
- Study start
- 11 Sep 2021 (actual)
- Primary completion
- 19 Sep 2021 (actual)
- Study completion
- 19 Sep 2021 (actual)
- First posted
- 21 Mar 2023 (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.
Purpose of this study was to assess the balance level of highly qualified amputee football players in relation to their sports level, training experience, position on the pitch, as well as the type of amputation/dysfunction and disability experience.
Detailed description
The participants were presented with the procedure of the study and informed that they could resign from their participation in the study at any stage. All participants were given the written informed consent form after the detailed written and oral explanation of the risk and benefits resulting from participation in this study Static balance was assessed using AMTI AccuSway stabilographic platform (ACS Model). The study participants performed the single 10 second left- or right-leg stance with eyes open (EO), and single 10 second left- or right-leg stance with eyes closed (EC) (depending on leg amputation). If the first attempt was not successful, study participants were able to do the second attempt. The tests were conducted on a match-free day, approximately 2 hours after a meal, in a sports outfit, in a specially designated room.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Members of 14 teams, field players with lower limb impairment participating in European Amputee Football Championship.
Key inclusion criteria (3 listed)
- participant of European Amputte Football Championschip
- field player (leg amputation or leg dysfunction)
- written consent form
Key exclusion criteria (4 listed)
- goalkeeper
- injury
- tiredness
- refusal
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 |
|---|---|---|
| Balance test10 second left- or right-leg stance with eyes open, and single 10 second left- or right-leg stance with eyes closed | Other | – |
Primary outcome
Center of pressure (CoP) path lenght was measured
Time frame: Baseline
CoP displacement analysis is used to assess postural sway, based on which the balance control function can be assessed
Surface area of stabilogram was mesured
Time frame: Baseline
Based on the analysis of the surface area of the stabilogram, the level of balance control can be assessed
Visual inspection indicator (VII) was measured
Time frame: Baseline
VII aggregates surface areas of stabilograms (cm2) with eyes open and closed. In theory, maximum value of the indicator may come to 100%. As a rule, it is positive, which means that the surface area of the stabilogram increases with eyes closed. The indicator is higher when the difference between the surface area of the stabilogram in the test with eyes closed and the surface area of the stabilogram in the test with eyes open is greater. Lower values of the VII may indicate a reduced role of visual control in maintaining balance or the lack of its compensation.
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 31 Mar 2023.
- Role of vision in static balance in persons with and without visual impairmentsLink provided by the sponsor.
- Effects of sport on static balance in athletes with visual impairmentsLink provided by the sponsor.
- 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.
Jolanta Marszałek, PhD study director
University of Physical Education in Warsaw
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 Amputation and Dysmelia, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
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 3 inclusion and 4 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 31 Mar 2023. 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 Poland. 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?
Center of pressure (CoP) path lenght was measured (time frame: Baseline). The study lists 3 primary outcomes in all. 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 31 Mar 2023.