Physical Activity and Sports for People With Special Needs

Amputation Clinical Trial

Official title:

Balance Assessment of People With Lower Limb Impairment Practicing Amputee Football

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05778799
• Other study ID #: Research Group no 4
• Status: Completed
• 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
• 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

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

External Links

•   Effects of sport on static balance in athletes with visual impairments
•   Role of vision in static balance in persons with and without visual impairments