NCT01433341

Brief Summary

Tetra-ataxiametric posturography is based on the measurement and computerized elaboration of electronic signals emitted by four footplates, one for each heel and toe, respectively. These are sensitive to vertical pressure produced by a subject standing straight but in various positions (feet parallel, in tandem, eyes closed, on pads, etc.). The method yields additional parameters not obtained by the traditional monoplate stabilometers, namely, weight-distribution patterns and correlation among six combinations of paired outputs from the two heels, two toes, heel/toe of each foot, and the two diagonals (tetra-ataxiametric synchronizations). Most athletic injuries occur at the end of an activity, when the participant is fatigue. It is likely that significant portion of the injuries result from instability of the lower extremity joints as a consequence of fatigue of the stabilizing muscles. Muscle fatigue increase postural sway, impaired muscle control, and increase the onset delay of movement. Comparing pre-exercise with post-exercise results for each athlete, should detect significant and clinically meaningful differences with the Tetra-ataxiametric measures of stability, interaction between Fourier Spectral Power Ranges of body sway, weight distributions, and synchronizations of toe parts. The method is suitable for young subjects, and the equipment is portable and tests can be conveniently carried out in a child's familiar training setting and right before/after exercise. The goal of the present study is to measure the balance of the athletes after different types of exercises, to measure the ability of the athletes to recover different types of exercises, and to measure the influence of increasing physical fitness on balance ability. Fifty basketball and football players between the ages of 12 and 18 years old will be examined following informed consent from the children and their legal guardian. Each participant would be measured three times during the year (pre-season, middle-season, and post-season), three times each (before-training, after aerobic warming-up, and after-training) on the Tetrax. Additionally, physical parameters (as height, and weight), anatomical parameters (as leg length), and joint range of movement, would be record.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2012

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

First Submitted

Initial submission to the registry

September 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

1.6 years

First QC Date

September 12, 2011

Last Update Submit

November 10, 2013

Conditions

Keywords

Normal young athletes

Outcome Measures

Primary Outcomes (1)

  • Posturography measures

    changes in posturography measures in athletes throughout a training season

    Training season

Study Arms (1)

Young athletes

Eligibility Criteria

Age12 Years - 18 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Thirty basketball and football players between the ages of 12 and 18 years old.

You may qualify if:

  • age 12-18 years
  • healthy athletes

You may not qualify if:

  • children with known disturbances in bone, muscle of nervous systems
  • children using medications that may cause problems in balance or coordination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dan Nemet

Kfar Saba, Israel

Location

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2011

First Posted

September 13, 2011

Study Start

March 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations