Quantification of Distribution of the Mass Center for a Controlled Force Platform Reaction to the Ground

May 15, 2018 updated by: Leandro Lazzareschi, Universidade Cruzeiro do Sul
This study developed a controlled soil reaction force platform that provided controlled mechanical stimuli to quantify the distribution of the center of mass as a function of the angular variation of the ankle in the elderly in the upright position.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Usually the balance evaluation the center of mass displacement for the analysis of postural control is assessed by means of force platforms. However, most of these devices are stationary, that is the patient is the dynamic element which can generate an evaluation with high subjectivity index. Therefore, this study aimed at developed a reaction force to the ground platform which provides mechanical stimuli controlled to quantify the distribution of the mass center as a function of the angular variation in the elderly ankle in the upright position. The construction of the prototype was divided into 3 steps, based on the two-dimensional movement of the ankle joint. In the 1st stage the construction of the mechanical assembly; in the 2nd stage development of the electronics; and 3rd stage the development of the supervisory system (control system). The force plataform was evaluated following the engineering functional tests such as: characterization and calibration of the sensors, the definition of the transfer function and accuracy of tests of angular movements (+ 10 ° and -10 ° to the movements of inversion and eversion, + 15 and -15º to the movements of dorsiflexion and plantar flexion). For the tests with volunteers were selected 30 volunteers.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • We included in this study individuals male and female
  • Age ranging from 20 to 85 years
  • Asymptomatic individuals
  • Must walk without the use of an attachment
  • Do not present motor deficit that makes the study impossible

Exclusion Criteria:

  • Decompensated congestive heart failure
  • Neurological or neurological diseases that interfere with significant neuromotor
  • Individuals who did not agree to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1 (adult)
Each volunteer stood on the platform. The duration of the tests was standardized at 10 seconds for each angulation variant of the test. The tilt variables occurred every 5 degrees oscillating in the two-dimensional movement of the ankle joint. The test was discontinued when the volunteer failed to remain balanced at the tested angulation for more than 10 seconds (thus shifting the foot (s) from the initial position or supporting with one and / or both arms at the therapist or at the support bars ) or when it reached maximum angulation
Device: force plate An equipment model with the approach of providing the evaluated person with the movement that is closest to the biomechanical and functional reality of the ankle and foot joint and which could equalize the possible changes of the center of mass would contribute to the clinical evaluation and would provide a more efficient therapeutic reasoning rehabilitation.
EXPERIMENTAL: Group 2 (elderly)
Each volunteer stood on the platform. The duration of the tests was standardized at 10 seconds for each angulation variant of the test. The tilt variables occurred every 5 degrees oscillating in the two-dimensional movement of the ankle joint. The test was discontinued when the volunteer failed to remain balanced at the tested angulation for more than 10 seconds (thus shifting the foot (s) from the initial position or supporting with one and / or both arms at the therapist or at the support bars ) or when it reached maximum angulation
Device: force plate An equipment model with the approach of providing the evaluated person with the movement that is closest to the biomechanical and functional reality of the ankle and foot joint and which could equalize the possible changes of the center of mass would contribute to the clinical evaluation and would provide a more efficient therapeutic reasoning rehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mass distribution
Time Frame: 15 minutes
The center of mass was measured by the patient remaining on the force platform, remaining for 10 seconds in each angulation variant Unit of measurement: Kilograms (kg)
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2016

Primary Completion (ACTUAL)

July 20, 2016

Study Completion (ACTUAL)

July 30, 2016

Study Registration Dates

First Submitted

May 3, 2018

First Submitted That Met QC Criteria

May 3, 2018

First Posted (ACTUAL)

May 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2018

Last Update Submitted That Met QC Criteria

May 15, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 56483816.8.0000.5497

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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