Balance Analysis System Through Biaxial Rotation Force Platform

Development of Balance Analysis System Through Biaxial Rotation Force Platform Posturography Combined With Electromyography

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.

Study Overview

• Status: Completed
• Conditions: Balancing Interference
• Intervention / Treatment: Device: Force platform

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Mogi das Cruzes, São Paulo, Brazil, 08780-911
      • Alessandro Pereira da Silva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Balance; Volunteers aged from 18 years to over 60 years were selected without compromise. The tests were performed in a single session lasting 1 hour where the volunteers will do the tests on the force platform.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electromyographic signal	Electromyographic signal of the anterior tibial and gastrocnemius muscle. unit of measurement in microvolts (µV).	1 hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Mogi das Cruzes
• Investigators: Principal Investigator: Alessandro P Silva, PhD, University of Mogi das Cruzes

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2019
• Primary Completion (Actual): November 11, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Electromyography; Posturography; Force platform; Center of pressure; Dynamic postural balance
• Other Study ID Numbers: 02651118.0.0000.5497

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No