Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2025-05-01
2025-05-26
Brief Summary
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Detailed Description
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Given the growing popularity of these devices on social media and among the general public-often promoted as tools for correcting deformities, relieving plantar pain, or improving foot posture-this study aims to objectively assess their actual benefits and limitations using scientific methods.
The study employs a pre-post observational design involving 40 adult volunteers. A comprehensive analysis is conducted before and after the application of toe separators, focusing on several key variables:
Intermetatarsal angles and spacing measured through imaging (ultrasound or X-ray).
Gait and plantar pressure distribution assessed with the Zebris system.
Digital circulation evaluated visually and via thermographic imaging.
Foot posture assessed using the validated Foot Posture Index (FPI-6).
Comfort perception measured through a Visual Analog Scale (VAS).
Participants are evaluated during static stance and dynamic walking conditions to determine how the devices affect natural biomechanics. Data is analyzed statistically using SPSS and JASP to compare pre- and post-intervention results, applying appropriate tests based on normality assumptions.
Ethical approval was obtained from the Ethics Committee of the Universidad Católica de Valencia, and all participants provided informed consent.
This project aims not only to inform podiatric practice but also to serve as a foundation for future, larger-scale clinical trials. Additionally, it seeks to counteract misinformation by offering evidence-based insights into a widely used but poorly studied orthotic product.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
No control group is included, as the main objective is to conduct an early investigation of the biomechanical and physiological impact of these orthotic devices. This design allows the detection of potential trends or preliminary effects, serving as a basis for future, more rigorous studies such as randomized controlled trials.
Measurements are taken at two time points:
Pre-intervention: Baseline evaluation without the toe separators.
Post-intervention: Evaluation after applying the toe separators.
This model is appropriate for exploratory phases, especially when the phenomenon under investigation-such as the widespread use of standard toe separators-has limited scientific literature and lacks empirical validation.
TREATMENT
SINGLE
The evaluator responsible for analyzing the results-such as plantar pressures, imaging, or comfort scores-will not have access to the timing or condition of the data. This approach ensures objective interpretation and minimizes potential bias related to expectations.
Study Groups
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Standard Toe Separator Intervention
Participants in this arm will undergo assessments before and after using standard, non-custom silicone toe separators.
Standard Silicone Toe Separator Application
Participants will be instructed to wear standard, commercially available silicone toe separators during a single evaluation session. The intervention consists of applying the separators between the toes while the participant is barefoot, both in static standing and while walking on a treadmill equipped with a Zebris pressure analysis system. Measurements will be taken immediately before and after the application, including plantar pressure distribution, intermetatarsal spacing (via imaging), digital circulation (via thermography and visual assessment), foot posture (using the Foot Posture Index - FPI-6), and subjective comfort levels (via Visual Analog Scale). The toe separators are not customized and reflect common consumer-grade devices marketed for podiatric or wellness purposes.
No-Intervention Control Group
Participants in the control arm will undergo the same evaluation procedures as the intervention group but without the application of toe separators.
No interventions assigned to this group
Interventions
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Standard Silicone Toe Separator Application
Participants will be instructed to wear standard, commercially available silicone toe separators during a single evaluation session. The intervention consists of applying the separators between the toes while the participant is barefoot, both in static standing and while walking on a treadmill equipped with a Zebris pressure analysis system. Measurements will be taken immediately before and after the application, including plantar pressure distribution, intermetatarsal spacing (via imaging), digital circulation (via thermography and visual assessment), foot posture (using the Foot Posture Index - FPI-6), and subjective comfort levels (via Visual Analog Scale). The toe separators are not customized and reflect common consumer-grade devices marketed for podiatric or wellness purposes.
Eligibility Criteria
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Inclusion Criteria
* Age 18 or older
* Voluntary participation with signed informed consent
* Students or staff from UCV clinics
Exclusion Criteria
* Diabetes Type I or II, post-surgical neuralgias, cerebral palsy, acquired hemiplegia, herniated discs with neural involvement, fibromyalgia)
* Presence of any diagnosed podiatric pathology
* Under 18 years of age
* Pregnant individuals
* Inability to understand or sign the informed consent form
18 Years
99 Years
ALL
Yes
Sponsors
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Fundación Universidad Católica de Valencia San Vicente Mártir
OTHER
Responsible Party
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Locations
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Clinicas UCV
Valencia, València, Spain
Countries
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References
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Abdalbary SA. Foot Mobilization and Exercise Program Combined with Toe Separator Improves Outcomes in Women with Moderate Hallux Valgus at 1-Year Follow-up A Randomized Clinical Trial. J Am Podiatr Med Assoc. 2018 Nov;108(6):478-486. doi: 10.7547/17-026. Epub 2018 Apr 23.
Dissaneewate T, Na Rungsri T, Cheunchokasan P, Leelasamran W. Comparison between the plantar pressure effects of toe separators and insoles in patients with hallux valgus at a one-month follow-up. Foot Ankle Surg. 2022 Jan;28(1):93-99. doi: 10.1016/j.fas.2021.02.005. Epub 2021 Feb 12.
Krzesniak H, Truszczynska-Baszak A. Toe Separators as a Therapeutic Tool in Physiotherapy-A Systematic Review. J Clin Med. 2024 Dec 19;13(24):7771. doi: 10.3390/jcm13247771.
Other Identifiers
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UCV/2023.2024/027.
Identifier Type: -
Identifier Source: org_study_id
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