EEECS: Evaluation of the Static Stability of Footwear

• Sponsor: JOSE MANUEL SANCHEZ SAEZ (Other)
• Overall Status: Completed
• CT.gov ID: NCT03764332
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arm: 1
• Actual Duration (Days): 28
• Patients Per Site Per Month: 28.3

Study Details

Study Description

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:

Condition or Disease	Intervention/Treatment	Phase
Postural; Strain	Device: Stabilometry	N/A

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

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Evaluation of the Static Stability of Footwear: A Clinical Trial
• Actual Study Start Date: Dec 7, 2018
• Actual Primary Completion Date: Dec 30, 2018
• Actual Study Completion Date: Jan 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Stabilometry 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.	Device: Stabilometry; To evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open.; Other Names: Eyes open and eyes closed

Outcome Measures

Primary Outcome Measures

1. Stroke length [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

2. Stroke surface [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

3. Relationship between Length / surface [30 seconds]

   Value resulting from the relationship between the two previous measures. The Podoprint pressure platform was used as a measuring device. Quantitative variable

4. Average swing speed [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

5. Lateral velocity [30 seconds]

   Average speed of oscillation in its axis of ordinates. The Podoprint pressure platform was used as a measuring device. Quantitative variable

6. Forward speed [30 seconds]

   Average oscillation speed on its abscissa axis. The Podoprint pressure platform was used as a measuring device. Quantitative variable

7. Average displacement in the X axis [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

8. Average displacement on the Y axis [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clínica López del Amo	Murcia		Spain	30008

Sponsors and Collaborators

• JOSE MANUEL SANCHEZ SAEZ

Investigators

• Principal Investigator: Jose Sanchez Saez, Podólogo, Universidade da Coruña

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: JOSE MANUEL SANCHEZ SAEZ, Principal investigator, Universidade da Coruña
• ClinicalTrials.gov Identifier: NCT03764332
• Other Study ID Numbers: 1402201803718
• First Posted: Dec 5, 2018
• Last Update Posted: Jan 7, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by JOSE MANUEL SANCHEZ SAEZ, Principal investigator, Universidade da Coruña: Footwear; Barefoot
• Additional relevant MeSH terms: Sprains and Strains

Study Results

No Results Posted as of Jan 7, 2019