Balancing InterferenceNCT04174690
Balance Analysis System Through Biaxial Rotation Force Platform
A study testing Force platform in people with Balancing Interference, run by University of Mogi das Cruzes at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Balancing Interference
- What is being tested?
- Force platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Oct 2019to 20 Dec 2019
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women
- Ages 18 to 80 years
- Asymptomatic
- Resident of the city of mogi das cruzes.
- You will have to sign the consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Balance Analysis System Through Biaxial Rotation Force Platform Posturography Combined With Electromyography
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.
Read the detailed description
The use of rotating force platforms has proven to be an important resource in the study of postural balance and motor control. Platforms composed of two force plates allow the analysis of the load relationship between the feet and the study of the coordination of the lower body segments in postural control. Center of pressure displacement data during perturbations generated by platform rotation allow the study of dynamic postural balance. However, devices that meet these characteristics are not common and have limitations on amplitude or speed of rotation. Thus, a force platform composed of two plates was developed, capable of collecting data for the calculation of the parameters of the center of pressure, differentiating each foot, with a computerized system to control amplitude and speed of rotation in the mid-lateral and anteroposterior axes. A new version of embedded and supervisory systems that control the device, collect and process the created data has also been developed. For platform functionality tests, volunteers were divided into three groups of 15 individuals: Group 1 (G1): women aged 18 to 40 years; Group 2 (G2): women aged 40 to 60 years; Group 3 (G3): women over 60 years old.
- Conditions
- Balancing Interference
- Being tested
- Force platform
- Keywords
- Center of pressure, Dynamic postural balance, Force platform, Posturography, Electromyography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Force platformDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Force platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 hour
Secondary outcomes (1)
Electromyographic signal
Electromyographic signal of the anterior tibial and gastrocnemius muscle. unit of measurement in microvolts (µV).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start14 Oct 2019
- Primary completion11 Nov 2019
- Study completion20 Dec 2019
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
- Model description
- Biaxial rotation force platform combined with electromyography
- Masking
- None (open label)
- Enrolment
- 45 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, PhD, Principal investigator, University of Mogi das Cruzes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174690
- Sponsor's protocol ID
- 02651118.0.0000.5497
- Status last verified
- Nov 2019
- First submitted
- 20 Nov 2019
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Balance Analysis System Through Biaxial Rotation Force Platform Posturography Combined With Electromyography
- ClinicalTrials.gov ID
- NCT04174690
- Acronym / sponsor ID
- 02651118.0.0000.5497
- Conditions
- Balancing Interference
- Keywords
- Center of pressure, Dynamic postural balance, Force platform, Posturography, Electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Mogi das CruzesUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 22 Nov 2019 (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 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.
Detailed description
The use of rotating force platforms has proven to be an important resource in the study of postural balance and motor control. Platforms composed of two force plates allow the analysis of the load relationship between the feet and the study of the coordination of the lower body segments in postural control. Center of pressure displacement data during perturbations generated by platform rotation allow the study of dynamic postural balance. However, devices that meet these characteristics are not common and have limitations on amplitude or speed of rotation. Thus, a force platform composed of two plates was developed, capable of collecting data for the calculation of the parameters of the center of pressure, differentiating each foot, with a computerized system to control amplitude and speed of rotation in the mid-lateral and anteroposterior axes. A new version of embedded and supervisory systems that control the device, collect and process the created data has also been developed. For platform functionality tests, volunteers were divided into three groups of 15 individuals: Group 1 (G1): women aged 18 to 40 years; Group 2 (G2): women aged 40 to 60 years; Group 3 (G3): women over 60 years old.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Biaxial rotation force platform combined with electromyography
| Arm | Type | Receives |
|---|---|---|
| Balance | Experimental | Device: Force platformVolunteers 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women
- Ages 18 to 80 years
- Asymptomatic
- Resident of the city of mogi das cruzes.
- You will have to sign the consent form
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Force platformIn 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. | Device | Balance |
Primary outcome
Center of pressure offset
Time frame: 1 hour
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 secondary outcome
Electromyographic signal
Time frame: 1 hour
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 19 May 2020.
- Individual participant dataSharing planned: No
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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, PhD 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 Force platform 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 5 inclusion and 5 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 19 May 2020. 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?
Center of pressure offset (time frame: 1 hour). 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 19 May 2020.