NCT05778799

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2021

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

8 days

First QC Date

March 10, 2023

Last Update Submit

March 29, 2023

Conditions

Keywords

AmputationAmputee FootballPerformanceBalance

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Interventions

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

Eligibility Criteria

Age16 Years+
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Members of 14 teams, field players with lower limb impairment participating in European Amputee Football Championship.

You may qualify if:

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

You may not qualify if:

  • goalkeeper
  • injury
  • tiredness
  • refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Physical Education

Warsaw, 00-968, Poland

Location

Related Links

MeSH Terms

Conditions

Lower Extremity Deformities, Congenital

Condition Hierarchy (Ancestors)

Limb Deformities, CongenitalMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jolanta Marszałek, PhD

    University of Physical Education in Warsaw

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2023

First Posted

March 21, 2023

Study Start

September 11, 2021

Primary Completion

September 19, 2021

Study Completion

September 19, 2021

Last Updated

March 31, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations