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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list