Condition category
Not Applicable
Date applied
15/01/2018
Date assigned
23/01/2018
Last edited
23/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In the last 20 years, posturography (techniques that measure posture and stance) has been widely used in the medical field. The aim of this study is to collect data from posturography of a wide set of healthy volunteers from various European countries using a force platform and a standardized method of measurement.

Who can participate?
Healthy volunteers aged between 7 and 86

What does the study involve?
Participants are assessed using the Romberg test with a force platform. In the Romberg test the standing participant is asked to close their eyes and their swaying is measured with a force platform, an instrument that measures the ground reaction forces to quantify balance and gait.

What are the possible benefits and risks of participating?
These results could be used as normal values for posturography assessments in similar populations. Because the force platform method in itself is biased and may interfere with a correct diagnosis of a good or bad posture, percentile values are presented that would be more helpful to professionals in understanding posturography recordings. Ultimately, participants can have an assessment of their stability by comparing it with a representative sample.

Where is the study run from?
University of Palermo (Italy)

When is the study starting and how long is it expected to run for?
September 2014 to December 2016

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Antonino Patti
antonino.patti01@unipa.it

Trial website

Contact information

Type

Scientific

Primary contact

Dr Antonino Patti

ORCID ID

http://orcid.org/0000-0003-3753-5191

Contact details

Via Giovanni Pascoli 6
Palermo
90144
Italy
+39 (0)9123896910
antonino.patti01@unipa.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Postural control and balance in a cohort of healthy people living in Europe: posturography-derived normative data

Acronym

Study hypothesis

The main aim of this study was to identify values of normality threshold common to all subjects and independent of anthropometric parameters and sex in the sway patterns of healthy subjects during quiet standing.

Ethics approval

Ethics Committee of the University of Palermo - Consiglio di Dipartimento SPPF Prot. n. 290/2014; punto all’ordine del giorno numero 10; approval number: 290-2014/MEDF-02/11

Study design

Observational cross sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

The subjects did not have to be professional sportsmen

Intervention

Data were collected from 2014 to 2016. Detailed descriptions of the study sampling and recruitment approaches, standardization, data collection, analysis strategies, quality control activities, and inclusion criteria were approved by all operators who participated in the research. A random cluster sampling of 914 healthy subjects aged between 7.0 and 85.99 years, stratified by age, was carried out. The subjects did not have to be professional sportsmen.

Posturography values were measured using the FreeMed posturography system, including the FreeMed baropodometric platform and FreeStep v.1.0.3 software. The system had been calibrated to sample postural sway at 25  Hz, in real time. The sensors, coated with 24 K gold, guaranteed repeatability and reliability of the instrument (Sensor Medica, Guidonia Montecelio, Roma, Italy). Participants were asked to take the standardized Romberg test position on the baropodometric platform for 51,2 sec. Data from the platform were converted in accordance with instructions provided by the manufacturer and transformed into coordinates of CoP. The following parameters of the statokinesigram were considered in open eyes conditions: length of sway path of the CoP (SP); ellipse surface area (ES); coordinates of the CoP along the frontal (X; right-left; x-mean) and sagittal (Y; forward-backward; y-mean) planes.

To provide percentile values of our cohort, data were processed to obtain five curves corresponding to the following percentiles: 10th, 25th, 50th, 75th, and 90th. Distance-weighted least squares was used to represent the percentile on appropriate graphs. The measurements were obtained, providing age-specific percentile values related to each posturography component considered.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Postural sway at 25  Hz measured using the FreeMed posturography system during quiet standing

Secondary outcome measures

N/A

Overall trial start date

19/09/2014

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. A random cluster sampling of 914 healthy subjects aged between 7.0 and 85.99 years, stratified by age, was carried out
2. The subjects did not have to be professional sportsmen

Participant type

Healthy volunteer

Age group

Mixed

Gender

Both

Target number of participants

914

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

19/09/2014

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Italy, Spain, Turkey

Trial participating centre

University of Palermo
Department of Psychology and Educational Science
90144
Italy

Sponsor information

Organisation

University of Palermo

Sponsor details

Department of Psychology and Educational Science
Via Giovanni Pascoli 6
Palermo
90144
Italy
+39 (0)9123896910
antonino.patti01@unipa.it

Sponsor type

University/education

Website

www.unipa.it

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

All the data collected during the research will be shared by presenting the results of the study in national and international conferences and then by publishing in peer reviewed journals.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Antonino Patti (antonino.patti01@unipa.it). Datasets: Raw data, not processed and anonymous. Personal data of participants will be kept confidential. Anthropometric measurements of participants will be provided anonymously. Data will be available after completion of analysis and it will be disposed of in 5 years as per university policy. The data will be shared anonymously upon request from the researchers with journals and the working research groups. Consent from the guardians while assents from the children (participants) have been taken before the trial. Each participant will be given a proper trial registration no. at the beginning of trial. All the data will be linked anonymized. Ethical approval has been acquired from the research ethics committee of University of Palermo.

Intention to publish date

23/01/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes