NCT04174690

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2019

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

May 19, 2020

Status Verified

November 1, 2019

Enrollment Period

28 days

First QC Date

November 20, 2019

Last Update Submit

May 18, 2020

Conditions

Keywords

Center of pressureDynamic postural balanceForce platformPosturographyElectromyography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Electromyographic signal

    1 hour

Other Outcomes (1)

  • Speed of movement of center of pressure

    1 hour

Study Arms (1)

Balance

EXPERIMENTAL

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

Interventions

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.

Balance

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women
  • Ages 18 to 80 years
  • Asymptomatic
  • Resident of the city of mogi das cruzes.
  • You will have to sign the consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alessandro Pereira da Silva

Mogi das Cruzes, São Paulo, 08780-911, Brazil

Location

Study Officials

  • Alessandro P Silva, PhD

    University of Mogi das Cruzes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Biaxial rotation force platform combined with electromyography
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2019

First Posted

November 22, 2019

Study Start

October 14, 2019

Primary Completion

November 11, 2019

Study Completion

December 20, 2019

Last Updated

May 19, 2020

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations