Clinical trial NCT07004543: Evaluation of Toe Separators in Foot Health
Official title: Evaluation of Toe Separators in Foot Health: A Pilot Observational Study (STEP-IN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health-Related Behavior
Keywords: Toe separators
Gait analysis
Plantar pressure
Lead sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plantar Pressure Distribution
timeFrame: Baseline and immediately post-intervention
Secondary outcomes:
measure: Intermetatarsal Angles (2nd-3rd, 3rd-4th, 4th-5th)
timeFrame: Baseline and immediately post-intervention
measure: Intermetatarsal Spaces
timeFrame: Baseline and immediately post-intervention
measure: Gait Parameters
timeFrame: Baseline and immediately post-intervention
measure: Foot Posture Index
timeFrame: Baseline and immediately post-intervention
measure: Perceived Comfort
timeFrame: Baseline and immediately post-intervention
measure: Digital Circulation
timeFrame: Baseline and immediately post-intervention
measure: Digital Circulation
timeFrame: Baseline and immediately post-intervention
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Clinicas UCV
state: València
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.