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Completed

NCT Number: NCT05778799

Physical Activity and Sports for People With Special Needs

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.

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Key information

Conditions

Amputation Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dysmelia Leg; Deformity, Congenital Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases

Age range

16 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University of Physical Education

Warsaw, 00-968, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • participant of European Amputte Football Championschip
  • field player (leg amputation or leg dysfunction)
  • written consent form

Exclusion criteria

  • goalkeeper
  • injury
  • tiredness
  • refusal

Treatment and study plan

Balance test

Other

10 second left- or right-leg stance with eyes open, and single 10 second left- or right-leg stance with eyes closed

Primary outcomes

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Józef Piłsudski University of Physical Education

Other

Registry information

Official study title

Balance Assessment of People With Lower Limb Impairment Practicing Amputee Football

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 21, 2023
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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