Balancing InterferenceNCT03743506
An Instrumented Wobble Board to Present the Distribution and Center of Pressure in Dynamic Balance
A study testing With feedback and Without feedback in people with Balancing Interference, run by University of Mogi das Cruzes at 1 site in Brazil.
Trial summary
This study quantified the displacement of the center of pressure in the computer in real time and record this data for future analyzes Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Balancing Interference
- What is being tested?
- With feedback and Without feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Nov 2017to 12 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Absence of musculoskeletal alteration in the lower limbs;
- consent form signed by the volunteer;
- with preserved cognitive
Who cannot join
- Present some impairment of the skeletal muscles of the lower limbs;
- Present cognitive deficit.
Trial locations and contacts
1 site in 1 country.
About this study
This study quantified the displacement of the center of pressure in the computer in real time and record this data for future analyzes
Read the 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.
- Conditions
- Balancing Interference
- Being tested
- With feedback, Without feedback
- Keywords
- Wobble board, center of pressure, dynamic balance, force platform
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With feedbackDiagnostic test
To evaluate the displacement of the center of pressure on the disc during the equilibration with feedback.
Without feedbackDiagnostic test
To evaluate the displacement of the center of pressure on the disc during the equilibration without feedback.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: With feedback; Diagnostic Test: Without feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 15 minutes
Secondary outcomes (1)
Longest distance between points on X and Y axis
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).
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start6 Nov 2017
- Primary completion10 Nov 2018
- Study completion12 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balancing InterferenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mogi das Cruzes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terigi Augusto Scardovelli, University of Mogi das Cruzes
- Investigators
- Alessandro P Silva, Ph.D, Principal investigator, University of Mogi das Cruzes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743506
- Sponsor's protocol ID
- 78363617.7.0000.5497
- Status last verified
- Jul 2019
- First submitted
- 13 Nov 2018
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Instrumented Wobble Board to Present the Distribution and Center of Pressure in Dynamic Balance
- ClinicalTrials.gov ID
- NCT03743506
- Acronym / sponsor ID
- 78363617.7.0000.5497
- Conditions
- Balancing Interference
- Keywords
- Wobble board, center of pressure, dynamic balance, force platform
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Mogi das CruzesUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 10 Nov 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study quantified the displacement of the center of pressure in the computer in real time and record this data for future analyzes
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteers without motor abnormalities. | Experimental | Diagnostic Test: With feedback, Diagnostic Test: Without feedbackThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Absence of musculoskeletal alteration in the lower limbs;
- consent form signed by the volunteer;
- with preserved cognitive
Key exclusion criteria (2 listed)
- Present some impairment of the skeletal muscles of the lower limbs;
- Present cognitive deficit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| With feedbackTo evaluate the displacement of the center of pressure on the disc during the equilibration with feedback. | Diagnostic test | Volunteers without motor abnormalities. |
| Without feedbackTo evaluate the displacement of the center of pressure on the disc during the equilibration without feedback. | Diagnostic test | Volunteers without motor abnormalities. |
Primary outcome
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).
1 secondary outcome
Longest distance between points on X and Y axis
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro P Silva, Ph.D principal investigator
University of Mogi das Cruzes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With feedback and Without feedback in people with Balancing Interference, run by University of Mogi das Cruzes at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure center displacement speed (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.