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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05778799
Other study ID # Research Group no 4
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 11, 2021
Est. completion date September 19, 2021

Study information

Verified date March 2023
Source Józef Pilsudski University of Physical Education
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date September 19, 2021
Est. primary completion date September 19, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 16 Years and older
Eligibility Inclusion Criteria: - participant of European Amputte Football Championschip - field player (leg amputation or leg dysfunction) - written consent form Exclusion Criteria: - goalkeeper - injury - tiredness - refusal

Study Design


Related Conditions & MeSH terms

  • Amputation
  • Lower Extremity Deformities, Congenital

Intervention

Other:
Balance test
10 second left- or right-leg stance with eyes open, and single 10 second left- or right-leg stance with eyes closed

Locations

Country Name City State
Poland University of Physical Education Warsaw

Sponsors (1)

Lead Sponsor Collaborator
Józef Pilsudski University of Physical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline
Primary 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 Baseline
Primary 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. Baseline
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