- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03764332
Evaluation of the Static Stability of Footwear (EEECS)
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:
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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-
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Murcia, Spanien, 30008
- Clínica López del Amo
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Övrig: 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.
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To evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Stroke length
Tidsram: 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 |
30 seconds
|
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Stroke surface
Tidsram: 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 |
30 seconds
|
|
Relationship between Length / surface
Tidsram: 30 seconds
|
Value resulting from the relationship between the two previous measures. The Podoprint pressure platform was used as a measuring device. Quantitative variable |
30 seconds
|
|
Average swing speed
Tidsram: 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 |
30 seconds
|
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Lateral velocity
Tidsram: 30 seconds
|
Average speed of oscillation in its axis of ordinates.
The Podoprint pressure platform was used as a measuring device.
Quantitative variable
|
30 seconds
|
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Forward speed
Tidsram: 30 seconds
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Average oscillation speed on its abscissa axis.
The Podoprint pressure platform was used as a measuring device.
Quantitative variable
|
30 seconds
|
|
Average displacement in the X axis
Tidsram: 30 seconds
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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 |
30 seconds
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Average displacement on the Y axis
Tidsram: 30 seconds
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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 |
30 seconds
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Jose Sanchez Saez, Podólogo, Universidade da Coruña
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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