- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03743506
An Instrumented Wobble Board to Present the Distribution and Center of Pressure in Dynamic Balance
July 2, 2019 updated by: Terigi Augusto Scardovelli, University of Mogi das Cruzes
This study quantified the displacement of the center of pressure in the computer in real time and record this data for future analyzes
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The wobble board is an unstable equilibrium platform, constant training on this platform generates an improvement in balance and strengthens the muscles, it is ideal for rehabilitation exercises and balance conditioning.
However, these platforms do not provide quantitative data on exercises performed on it.
And the force platform that provide this quantitative data is static, offering no difficulty in maintaining balance.
In this way, a sensor board wobble board was developed using a conventional wobble board with a plate attached to it, between the plate and the platform are eight strain gauges sensors that are activated according to the position of the force applied on the platform, the values of the sensors are collected by software that demonstrates the point of greatest pressure on the disk and its displacement during the exercises, with this data it is possible to determine the stability of the user and observe their behavior during the exercises.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
-
Mogi das Cruzes, São Paulo, Brazil, 08780-911
- Alessandro Pereira da Silva
-
-
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
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Absence of musculoskeletal alteration in the lower limbs;
- consent form signed by the volunteer;
- with preserved cognitive
Exclusion Criteria:
- Present some impairment of the skeletal muscles of the lower limbs;
- Present cognitive deficit.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Volunteers without motor abnormalities.
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.
|
To evaluate the displacement of the center of pressure on the disc during the equilibration with feedback.
To evaluate the displacement of the center of pressure on the disc during the equilibration without feedback.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure center displacement speed
Time Frame: 15 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Longest distance between points on X and Y axis
Time Frame: 15 minutes
|
It was measured at the greatest distance of the center of pressure displacement on the X and Y axis during the test, divided into two steps, with three repetitions at each stage, with a rest of 30 seconds at each repetition.
Unit of measurement: Centimeters (cm).
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alessandro P Silva, Ph.D, University of Mogi das Cruzes
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)
November 6, 2017
Primary Completion (Actual)
November 10, 2018
Study Completion (Actual)
December 12, 2018
Study Registration Dates
First Submitted
November 13, 2018
First Submitted That Met QC Criteria
November 13, 2018
First Posted (Actual)
November 16, 2018
Study Record Updates
Last Update Posted (Actual)
July 5, 2019
Last Update Submitted That Met QC Criteria
July 2, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 78363617.7.0000.5497
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.
Clinical Trials on Balancing Interference
-
University of Mogi das CruzesCompleted
-
Cleveland State UniversitySuspendedFall Injury | Balancing Interference | Fall AccidentUnited States
-
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical...Taipei Medical UniversityCompletedStroke | Balancing Interference | Walking, DifficultyTaiwan
-
Deutsches Herzzentrum MuenchenCompletedElectromagnetic InterferenceGermany, Greece
-
Edward-Elmhurst Health SystemCompletedElectromagnetic InterferenceUnited States
-
University Hospital, GenevaCompletedElectromagnetic InterferenceSwitzerland
-
Maisonneuve-Rosemont HospitalCompletedElectromagnetic Interference
-
Radicle ScienceActive, not recruitingPain InterferenceUnited States
-
Deutsches Herzzentrum MuenchenBayerisches Staatsministerium für Wirtschaft; R & S GmbH und Co KGCompletedElectromagnetic InterferenceGermany
-
Deutsches Herzzentrum MuenchenCompletedElectromagnetic InterferenceGermany
Clinical Trials on With feedback
-
Vanderbilt University Medical CenterCompletedHearing Loss | Language ImpairmentUnited States
-
MGH Institute of Health ProfessionsRecruitingDevelopmental Language DisorderUnited States
-
Northwestern UniversityCompletedAutism Spectrum Disorder | AutismUnited States
-
Pro-Active Medical Pty LtdDepartment of Business and Innovation, Victoria, AustraliaCompletedLow Back PainAustralia
-
VA Office of Research and DevelopmentDurham VA Health Care System; VA Salt Lake City Health Care System; Birmingham...Completed
-
National Yang Ming UniversityNot yet recruitingStroke Syndrome
-
US Department of Veterans AffairsCompletedDiabetes | Peripheral NeuropathyUnited States
-
University Hospital, CaenUnknown
-
University of Maryland, College ParkCompleted
-
University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsWithdrawn