Evaluation of Toe Separators in Foot Health

NCT07004543 | Completed

• 1 other identifier: UCV/2023.2024/027.
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Health-Related Behavior

Keywords

Toe separators; Gait analysis; Plantar pressure

Outcome Measures

Primary Outcomes (1)

• Plantar Pressure Distribution

  Zebris treadmill analysis

  Baseline and immediately post-intervention

Secondary Outcomes (7)

• Intermetatarsal Angles (2nd-3rd, 3rd-4th, 4th-5th)

  Baseline and immediately post-intervention

• Intermetatarsal Spaces

  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

Study Arms (2)

Standard Toe Separator Intervention

EXPERIMENTAL

Participants in this arm will undergo assessments before and after using standard, non-custom silicone toe separators.

Procedure: Standard Silicone Toe Separator Application

No-Intervention Control Group

NO INTERVENTION

Participants in the control arm will undergo the same evaluation procedures as the intervention group but without the application of toe separators.

Interventions

Standard Silicone Toe Separator Application PROCEDURE

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.

Standard Toe Separator Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult participants (without foot pathologies)
• Age 18 or older
• Voluntary participation with signed informed consent
• Students or staff from UCV clinics

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Universidad Católica de Valencia San Vicente Mártir: lead

Study Sites (1)

Clinicas UCV

Valencia, València, 46001, Spain

Location

Related Publications (3)

• 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.

  PMID: 29683337 BACKGROUND

• 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.

  PMID: 33612377 BACKGROUND

• 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.

  PMID: 39768694 BACKGROUND

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: June 4, 2025
• Study Start: May 1, 2025
• Primary Completion: May 26, 2025
• Study Completion: May 26, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: All published results and associated materials will be accessible indefinitely through institutional repositories or journal archives,

Locations

ES (1)