Evaluation of Toe Separators in Foot Health: A Pilot Observational Study (STEP-IN)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Plantar Pressure Distribution
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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.
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Standard Toe Separator Intervention
Participants in this arm will undergo assessments before and after using standard, non-custom silicone toe separators.
Intervention: Standard Silicone Toe Separator Application (Procedure)
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.
Outcomes
Primary Outcomes
Plantar Pressure Distribution
Time Frame: Baseline and immediately post-intervention
Zebris treadmill analysis
Secondary Outcomes
- Intermetatarsal Spaces(Baseline and immediately post-intervention)
- Digital Circulation(Baseline and immediately post-intervention)
- Intermetatarsal Angles (2nd-3rd, 3rd-4th, 4th-5th)(Baseline and immediately post-intervention)
- Gait Parameters(Baseline and immediately post-intervention)
- Foot Posture Index(Baseline and immediately post-intervention)
- Perceived Comfort(Baseline and immediately post-intervention)