Postural; StrainEEECSNCT03764332
Evaluation of the Static Stability of Footwear
A study testing Stabilometry in people with Postural; Strain, run by JOSE MANUEL SANCHEZ SAEZ at 1 site in Spain.
Trial summary
Introduction: Postural control is a crucial factor for maintaining balance while standing and walking. The shoe has a role to play in postural stability. Objectives: To evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open. Material and methods: Read more about this study
- Who is it for?
- Ages 25 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural; Strain
- What is being tested?
- Stabilometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 7 Dec 2018to 4 Jan 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 25 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Acceptance and signature of informed consent.
- Persons aged between 25-35 years.
- People with a weight between 40 and 95kg.
- People with a height between 1.50 and 1.90m
Who cannot join
- People with surgical history of lower limbs.
- People with systemic pathology / algia that can alter the physiological static pattern.
- Congenital deformities or acquired in childhood.
- If after a complete exploration in decubitus, sitting, static standing and gait dynamics, any anomaly that could negatively influence the acquisition of data for the study was detected.
- Patients who do not accept or sign the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Static Stability of Footwear: A Clinical Trial
Introduction: Postural control is a crucial factor for maintaining balance while standing and walking. The shoe has a role to play in postural stability.
Objectives: To evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open.
Material and methods:
Read the detailed description
Each participant was asked to focus on a white mark 2 cm in diameter, positioned on a screen 2 m in front of them at eye level. This was done to standardize the data collection and minimize any variation in postural stability caused by changes in the visual field. Each participant was asked to remain in this position for a period of 30 seconds, while the data was collected. Three repetitions were made for each condition to obtain an average value. The condition on footwear and open / closed eyes was randomized to reduce the learning effect. On the other hand to reduce fatigue, each participant was allowed to rest for 5 minutes between shoe changes.
The size of the sample was calculated with the software of the Clinical Epidemiology and Biostatistics Unit. Complexo Hospitalario Universitario de A Coruña. University of A Coruña (www.fisterra.com). The estimated sample size estimated was calculated to be at least 16 subjects.
- Conditions
- Postural; Strain
- Being tested
- Stabilometry
- Keywords
- Footwear, Barefoot
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StabilometryDevice
Also called Eyes open and eyes closed
To evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open.
| Study group | Role | What they receive |
|---|---|---|
| Stabilometry | Other | The Podoprint pressure platform was used as a measuring device. The Podoprint platform is a low profile floor platform consisting of 1.4 sensors / cm2 with a sampling frequency of 40Hz. Receives: Device: Stabilometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke length
Length traveled by the pressure center (CoP), forming a line called oscillatory ball. In mm. The Podoprint pressure platform was used as a measuring device.
Quantitative variable
Measured: 30 seconds
Stroke surface
Area of the smallest ellipse able to encompass the oscillating ball. In mm. The Podoprint pressure platform was used as a measuring device.
Quantitative variable
Measured: 30 seconds
Relationship between Length / surface
Value resulting from the relationship between the two previous measures. The Podoprint pressure platform was used as a measuring device.
Quantitative variable
Measured: 30 seconds
Average swing speed
Average speed that reaches the displacement of the center of pressures. The Podoprint pressure platform was used as a measuring device.
Quantitative variable
Measured: 30 seconds
Lateral velocity
Average speed of oscillation in its axis of ordinates. The Podoprint pressure platform was used as a measuring device. Quantitative variable
Measured: 30 seconds
Forward speed
Average oscillation speed on its abscissa axis. The Podoprint pressure platform was used as a measuring device. Quantitative variable
Measured: 30 seconds
Average displacement in the X axis
Average of the displacements made by the center of pressures in the axis of ordinates. The Podoprint pressure platform was used as a measuring device.
Quantitative variable
Measured: 30 seconds
Average displacement on the Y axis
Average of the displacements made by the center of pressures on the abscissa axis. The Podoprint pressure platform was used as a measuring device.
Quantitative variable
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start7 Dec 2018
- Primary completion30 Dec 2018
- Study completion4 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postural; StrainStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- JOSE MANUEL SANCHEZ SAEZ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, JOSE MANUEL SANCHEZ SAEZ, Universidade da Coruña
- Investigators
- Jose Sanchez Saez, Podólogo, Principal investigator, Universidade da Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764332
- Sponsor's protocol ID
- 1402201803718
- Acronym
- EEECS
- Status last verified
- Jan 2019
- First submitted
- 27 Nov 2018
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanchez-Saez JM, Palomo-Lopez P, Becerro-de-Bengoa-Vallejo R, Calvo-Lobo C, Losa-Iglesias ME, Lopez-Del-Amo-Lorente A, Lopez-Lopez D. Stability of Three Different Sanitary Shoes on Healthcare Workers: A Cross-Sectional Study. Int J Environ Res Public Health. 2019 Jun 16;16(12):2126. doi: 10.3390/ijerph16122126.
PubMed 31208123
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Static Stability of Footwear: A Clinical Trial
- ClinicalTrials.gov ID
- NCT03764332
- Acronym / sponsor ID
- EEECS / 1402201803718
- Conditions
- Postural; Strain
- Keywords
- Footwear, Barefoot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- JOSE MANUEL SANCHEZ SAEZUniversity, hospital or other
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 4 Jan 2019 (actual)
- First posted
- 5 Dec 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.
Introduction: Postural control is a crucial factor for maintaining balance while standing and walking. The shoe has a role to play in postural stability.
Objectives: To evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open.
Material and methods:
Detailed description
Each participant was asked to focus on a white mark 2 cm in diameter, positioned on a screen 2 m in front of them at eye level. This was done to standardize the data collection and minimize any variation in postural stability caused by changes in the visual field. Each participant was asked to remain in this position for a period of 30 seconds, while the data was collected. Three repetitions were made for each condition to obtain an average value. The condition on footwear and open / closed eyes was randomized to reduce the learning effect. On the other hand to reduce fatigue, each participant was allowed to rest for 5 minutes between shoe changes.
The size of the sample was calculated with the software of the Clinical Epidemiology and Biostatistics Unit. Complexo Hospitalario Universitario de A Coruña. University of A Coruña (www.fisterra.com). The estimated sample size estimated was calculated to be at least 16 subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stabilometry | Other | Device: StabilometryThe Podoprint pressure platform was used as a measuring device. The Podoprint platform is a low profile floor platform consisting of 1.4 sensors / cm2 with a sampling frequency of 40Hz. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Acceptance and signature of informed consent.
- Persons aged between 25-35 years.
- People with a weight between 40 and 95kg.
- People with a height between 1.50 and 1.90m
Key exclusion criteria (5 listed)
- People with surgical history of lower limbs.
- People with systemic pathology / algia that can alter the physiological static pattern.
- Congenital deformities or acquired in childhood.
- If after a complete exploration in decubitus, sitting, static standing and gait dynamics, any anomaly that could negatively influence the acquisition of data for the study was detected.
- Patients who do not accept or sign the informed consent
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 |
|---|---|---|
| StabilometryAlso: Eyes open and eyes closedTo evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open. | Device | Stabilometry |
Primary outcome
Stroke length
Time frame: 30 seconds
Length traveled by the pressure center (CoP), forming a line called oscillatory ball. In mm. The Podoprint pressure platform was used as a measuring device. Quantitative variable
Stroke surface
Time frame: 30 seconds
Area of the smallest ellipse able to encompass the oscillating ball. In mm. The Podoprint pressure platform was used as a measuring device. Quantitative variable
Relationship between Length / surface
Time frame: 30 seconds
Value resulting from the relationship between the two previous measures. The Podoprint pressure platform was used as a measuring device. Quantitative variable
Average swing speed
Time frame: 30 seconds
Average speed that reaches the displacement of the center of pressures. The Podoprint pressure platform was used as a measuring device. Quantitative variable
Lateral velocity
Time frame: 30 seconds
Average speed of oscillation in its axis of ordinates. The Podoprint pressure platform was used as a measuring device. Quantitative variable
Forward speed
Time frame: 30 seconds
Average oscillation speed on its abscissa axis. The Podoprint pressure platform was used as a measuring device. Quantitative variable
Average displacement in the X axis
Time frame: 30 seconds
Average of the displacements made by the center of pressures in the axis of ordinates. The Podoprint pressure platform was used as a measuring device. Quantitative variable
Average displacement on the Y axis
Time frame: 30 seconds
Average of the displacements made by the center of pressures on the abscissa axis. The Podoprint pressure platform was used as a measuring device. Quantitative variable
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 7 Jan 2019.
- Derived from this study: PubMed 31208123Sanchez-Saez JM, Palomo-Lopez P, Becerro-de-Bengoa-Vallejo R, Calvo-Lobo C, Losa-Iglesias ME, Lopez-Del-Amo-Lorente A, Lopez-Lopez D. Stability of Three Different Sanitary Shoes on Healthcare Workers: A Cross-Sectional Study. Int J Environ Res Public Health. 2019 Jun 16;16(12):2126. doi: 10.3390/ijerph16122126.
- Individual participant dataSharing planned: No
Related trials for Postural; Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Recruiting
Ergonomic Protocol for Competitive E-Sport Athletes
No Disease or Condition is Being Studied
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.
Jose Sanchez Saez, Podólogo principal investigator
Universidade da Coruña
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stabilometry in people with Postural; Strain, run by JOSE MANUEL SANCHEZ SAEZ at 1 site in Spain.
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 4 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 7 Jan 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 Spain. 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?
Stroke length (time frame: 30 seconds). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03764332, which also lists 1 linked publication.
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 7 Jan 2019.