Postural control and balance in a cohort of healthy people living in Europe: posturography-derived normative data
| ISRCTN | ISRCTN14957074 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14957074 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/01/2018
- Registration date
- 23/01/2018
- Last edited
- 27/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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
Contact information
Scientific
Via Giovanni Pascoli 6
Palermo
90144
Italy
 ORCID ID |
0000-0003-3753-5191 |
|---|---|
| Phone | +39 (0)9123896910 |
| antonino.patti01@unipa.it |
Study information
| Study design | Observational cross sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Postural control and balance in a cohort of healthy people living in Europe: posturography-derived normative data |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Postural sway at 25 Hz measured using the FreeMed posturography system during quiet standing |
| Secondary outcome measures | N/A |
| Overall study start date | 19/09/2014 |
| Completion date | 31/12/2016 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 914 |
| Total final enrolment | 914 |
| Key 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 |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 19/09/2014 |
| Date of final enrolment | 31/12/2016 |
Locations
Countries of recruitment
- Italy
- Spain
- Türkiye
Study participating centre
90144
Italy
Sponsor information
University/education
Department of Psychology and Educational Science
Via Giovanni Pascoli 6
Palermo
90144
Italy
| Phone | +39 (0)9123896910 |
|---|---|
| antonino.patti01@unipa.it | |
| Website | www.unipa.it |
"ROR" |
https://ror.org/044k9ta02 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 23/01/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/12/2018 | 27/02/2023 | Yes | No |
Editorial Notes
27/02/2023: Publication reference and total final enrolment added.
