NCT03743506

Brief Summary

This study quantified the displacement of the center of pressure in the computer in real time and record this data for future analyzes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

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

November 6, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2018

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

November 13, 2018

Last Update Submit

July 2, 2019

Conditions

Keywords

Wobble boardcenter of pressuredynamic balanceforce platform

Outcome Measures

Primary Outcomes (1)

  • Pressure center displacement speed

    The velocity at which the center of pressure moves during the test, divided into two steps, with three repetitions at each step, with a rest of 30 seconds at each repetition, was measured. Unit of measure: Centimeters per second (cm / s).

    15 minutes

Secondary Outcomes (1)

  • Longest distance between points on X and Y axis

    15 minutes

Study Arms (1)

Volunteers without motor abnormalities.

EXPERIMENTAL

The test was performed in a single, 30-minute session. The test is divided into two phases, with feedback and no feedback from the system. The order of phases was randomized. In each phase the volunteer will remain balanced on the wobble board for 15 seconds under the conditions of the phase. This test is repeated 3 times with a 30 seconds rest between them, then the next phase is performed. With feedback the volunteer can observe the system responses. Without feedback the volunteer can not observe the response of the system.

Diagnostic Test: With feedbackDiagnostic Test: Without feedback

Interventions

With feedbackDIAGNOSTIC_TEST

To evaluate the displacement of the center of pressure on the disc during the equilibration with feedback.

Volunteers without motor abnormalities.
Without feedbackDIAGNOSTIC_TEST

To evaluate the displacement of the center of pressure on the disc during the equilibration without feedback.

Volunteers without motor abnormalities.

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Absence of musculoskeletal alteration in the lower limbs;
  • consent form signed by the volunteer;
  • with preserved cognitive

You may not qualify if:

  • Present some impairment of the skeletal muscles of the lower limbs;
  • Present cognitive deficit.

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, Ph.D

    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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 13, 2018

First Posted

November 16, 2018

Study Start

November 6, 2017

Primary Completion

November 10, 2018

Study Completion

December 12, 2018

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations