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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04174690
Other study ID # 02651118.0.0000.5497
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 14, 2019
Est. completion date December 20, 2019

Study information

Verified date November 2019
Source University of Mogi das Cruzes
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study developed a system for studying an individual's postural balance in an upright position on a force platform with controlled movement of 2-axis rotation (transverse and anteroposterior), by analyzing lower limb muscle activation and data from Pressure Center of displacement.


Description:

The use of rotating force platforms has proven to be an important resource in the study of postural balance and motor control. Platforms composed of two force plates allow the analysis of the load relationship between the feet and the study of the coordination of the lower body segments in postural control. Center of pressure displacement data during perturbations generated by platform rotation allow the study of dynamic postural balance. However, devices that meet these characteristics are not common and have limitations on amplitude or speed of rotation. Thus, a force platform composed of two plates was developed, capable of collecting data for the calculation of the parameters of the center of pressure, differentiating each foot, with a computerized system to control amplitude and speed of rotation in the mid-lateral and anteroposterior axes. A new version of embedded and supervisory systems that control the device, collect and process the created data has also been developed. For platform functionality tests, volunteers were divided into three groups of 15 individuals: Group 1 (G1): women aged 18 to 40 years; Group 2 (G2): women aged 40 to 60 years; Group 3 (G3): women over 60 years old.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date December 20, 2019
Est. primary completion date November 11, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Women

- Ages 18 to 80 years

- Asymptomatic

- Resident of the city of mogi das cruzes.

- You will have to sign the consent form

Exclusion Criteria:

- History of dizziness or dizziness crisis not explained in the last year;

- Any musculoskeletal or neurological disorders;

- Significant pain that limits daily functions;

- Known uncorrected vestibular problems.

- Fall History

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Force platform
In order to volunteers to be selected for collection a recruitment test will be taken, the volunteer will have to stand on one foot for 5 seconds without additional support. So that the volunteer can go to the balance test on the force platform, he will be dressed with safety equipment (harness), and will also have the attachment of the electrodes.

Locations

Country Name City State
Brazil Alessandro Pereira da Silva Mogi das Cruzes São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Mogi das Cruzes

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Other Speed of movement of center of pressure With the volunteer allocated on the platform in an upright position with the malleoli aligned with the central axis of rotation of the platform will be collected the speed of the center of pressure unit of measure: millimeters per second (mm / s). 1 hour
Primary Center of pressure offset With the volunteer allocated on the platform in an upright position with the malleoli aligned with the central axis of rotation of the platform will be collected the displacement of the center of pressure. Unit of measure: millimeters (mm). 1 hour
Secondary Electromyographic signal Electromyographic signal of the anterior tibial and gastrocnemius muscle. unit of measurement in microvolts (µV). 1 hour
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