BalanceNCT03526198
Quantification of Distribution of the Mass Center for a Controlled Force Platform Reaction to the Ground
A study testing Force plate in people with Balance, run by Universidade Cruzeiro do Sul.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance
- What is being tested?
- Force plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 30 Jul 2016
- 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 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Decompensated congestive heart failure
- Neurological or neurological diseases that interfere with significant neuromotor
- Individuals who did not agree to participate in the study
About this study
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.
Read the 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.
- Conditions
- Balance
- Being tested
- Force plate
- Keywords
- Force plate, Center of mass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Force plateDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (adult) | Experimental | 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 Receives: Device: Force plate |
| Group 2 (elderly) | Experimental | 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 Receives: Device: Force plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass distribution
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)
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 May 2018
- Study start1 Jul 2016
- Primary completion20 Jul 2016
- Study completion30 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BalanceStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Cruzeiro do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leandro Lazzareschi, University of Mogi das Cruzes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526198
- Sponsor's protocol ID
- 56483816.8.0000.5497
- Status last verified
- May 2018
- First submitted
- 3 May 2018
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Distribution of the Mass Center for a Controlled Force Platform Reaction to the Ground
- ClinicalTrials.gov ID
- NCT03526198
- Acronym / sponsor ID
- 56483816.8.0000.5497
- Conditions
- Balance
- Keywords
- Force plate, Center of mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade Cruzeiro do SulUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 20 Jul 2016 (actual)
- Study completion
- 30 Jul 2016 (actual)
- First posted
- 16 May 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 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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (adult) | Experimental | Device: Force plateEach 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 |
| Group 2 (elderly) | Experimental | Device: Force plateEach 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 |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Decompensated congestive heart failure
- Neurological or neurological diseases that interfere with significant neuromotor
- Individuals who did not agree to participate in the study
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 plateDevice: 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. | Device | Group 1 (adult), Group 2 (elderly) |
Primary outcome
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)
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 18 May 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Force plate in people with Balance, run by Universidade Cruzeiro do Sul.
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 3 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 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Mass distribution (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 18 May 2018.