Clinical trial NCT03764332: Evaluation of the Static Stability of Footwear
Official title: Evaluation of the Static Stability of Footwear: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural; Strain
Keywords: Footwear
Barefoot
Lead sponsor: Universidade da Coruña
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 26
Sex: ALL
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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:

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Stroke length
timeFrame: 30 seconds
measure: Stroke surface
timeFrame: 30 seconds
measure: Relationship between Length / surface
timeFrame: 30 seconds
measure: Average swing speed
timeFrame: 30 seconds
measure: Lateral velocity
timeFrame: 30 seconds
measure: Forward speed
timeFrame: 30 seconds
measure: Average displacement in the X axis
timeFrame: 30 seconds
measure: Average displacement on the Y axis
timeFrame: 30 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Clínica López del Amo
Study officials:
affiliation: Universidade da Coruña
name: Jose Sanchez Saez, Podólogo
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.