Health-Related Behavior
Conditions
Keywords
Toe separators, Gait analysis, Plantar pressure
Brief summary
This pilot observational study investigates the effects of standard toe separators on foot health in asymptomatic individuals. It aims to evaluate their impact on intermetatarsal spacing, plantar pressure distribution, digital circulation, and user comfort. Through pre- and post-intervention measurements using tools like thermography, gait analysis (Zebris), and the Foot Posture Index, the research seeks to determine whether these commonly used orthotic devices provide measurable benefits or pose risks. The study ultimately contributes to evidence-based podiatric care and public health education.
Detailed description
This research project titled Evaluation of Toe Separators in Foot Health: A Pilot Observational Study (STEP-IN) explores the biomechanical and physiological effects of standard, commercially available toe separators on healthy individuals without pre-existing podiatric conditions. 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.
Interventions
PROCEDUREStandard 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.
Sponsors
Fundación Universidad Católica de Valencia San Vicente Mártir
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Each data set (pre- and post-intervention) will be assigned a random code (e.g., M1 and M2) without indicating whether it corresponds to the before or after condition. 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.
Intervention model description
This research follows a single-group pre-post design, also classified as a pre-experimental model. It is a pilot observational study aimed at exploring the initial effects of standard toe separators on foot health in healthy individuals. 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult participants (without foot pathologies) * Age 18 or older * Voluntary participation with signed informed consent * Students or staff from UCV clinics
Exclusion criteria
* Systemic conditions affecting foot sensitivity or circulation (e.g., Raynaud's syndrome, * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plantar Pressure Distribution | Baseline and immediately post-intervention | Zebris treadmill analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intermetatarsal Spaces | Baseline and immediately post-intervention | Quantitative (millimeters)Imaging (X-ray) |
| Gait Parameters | Baseline and immediately post-intervention | Zebris gait analysis system |
| Intermetatarsal Angles (2nd-3rd, 3rd-4th, 4th-5th) | Baseline and immediately post-intervention | Imaging (X-ray) |
| Perceived Comfort | Baseline and immediately post-intervention | After the toe separators are applied, the participant will be shown a 10-point Likert-type scale, included in the data collection sheet. It will be explained that they should indicate the degree of comfort they feel while wearing the toe separators by choosing a number from 1 to 10, where: 1 means very uncomfortable 10 means very comfortable The participant should select the number that best reflects their subjective perception of comfort at that moment. |
| Digital Circulation | Baseline and immediately post-intervention | A visual inspection of the participant's feet will be performed to identify any noticeable changes in skin color, swelling, alignment or other external signs of alteration. |
| Foot Posture Index | Baseline and immediately post-intervention | Foot Posture Index (FPI-6).is a clinical tool used to evaluate foot posture in the standing position, taking into account six visual criteria. Each is scored between -2 and +2, giving a total score ranging from -12 (very supinated foot) to +12 (very pronated foot). Score range: -12 (maximum supination) to +12 (maximum pronation). Interpretation of scores: Lower scores indicate a more supinated (less pronated) foot posture. Higher scores indicate a more pronated (less supinated) foot posture. |
Countries
Spain
Outcome results
None listed