Textured Insoles to Restore Sensorimotor Function in Patients With Plantar Fasciopathy (TIRE)

August 12, 2026 updated by: Jennifer Xu
This study will evaluate the immediate effects of wearing textured insoles on gait, postural control, and sensorimotor function in adults with plantar fasciopathy. Researchers will compare functional performance while participants wear textured insoles to determine whether this intervention may improve stability, movement and future studies of longer-term treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Plantar fasciopathy is a common condition that causes heel pain and is associated with impaired sensorimotor function, altered gait, reduced balance and decreased physical function. Current treatments primarily target symptom relief and do not directly address sensorimotor impairments. Textured insoles provide sensory stimulation to the plantar surface of the foot and may improve balance, gait mechanics and functional performance by enhancing plantar cutaneous input. This study will investigate the acute effects of textured insoles on gait, postural control and sensorimotor function in adults with plantar fasciopathy. Results will provide preliminary evidence regarding the feasibility and potential effectiveness of textured insoles as a treatment strategy and inform future studies evaluating longer-term outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jennifer Xu, PhD
  • Phone Number: 8593239850
  • Email: jen.xu@uky.edu

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University of Kentucky - Sports Medicine Research Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of plantar fasciopathy for at least 3 months
  • Able to walk continuously at a self-selected pace for at least 20 minutes
  • Able and willing to provide informed consent

Exclusion Criteria:

  • Concomitant lower extremity injury (example fracture)
  • History of lower extremity injury within the previous 6 months
  • History of hip, knee, or ankle surgery involving bones, joints, ligaments, tendons, or cartilage.
  • Any condition other than plantar fasciopathy that affects balance or plantar cutaneous sensation.
  • Neurological deficits, vestibular disorders, visual disturbances, or other conditions that impair movement or sensory function.
  • Pregnancy
  • Unable to speak or understand English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Textured Insole
Participants will wear textured insoles while completing gait, postural control, and sensorimotor function assessments to evaluate the acute effects of the intervention on plantar fasciopathy.
Other: Textured Insole
A textured shoe insole designed to provide plantar sensory stimulation by increasing cutaneous input to the foot during standing and walking.
Other: Smooth Insole
A smooth shoe insole without surface texture used as a control device for comparison with the textured insole.
Sham Comparator: Smooth Insole
Participants will wear a smooth (non-textured) insole while completing the same assessments to serve as the comparison condition in the crossover study.
Other: Textured Insole
A textured shoe insole designed to provide plantar sensory stimulation by increasing cutaneous input to the foot during standing and walking.
Other: Smooth Insole
A smooth shoe insole without surface texture used as a control device for comparison with the textured insole.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Postural Control
Time Frame: Baseline and immediately following completion of each intervention condition during the study visit
Postural control will be assessed while participants complete standardized balance testing under each study condition. Performance will be compared between the textured insole and smooth insole conditions to evaluate the acute effects of textured insoles on postural control.
Baseline and immediately following completion of each intervention condition during the study visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Gait Characteristics
Time Frame: Baseline and immediately following completion of each intervention condition during the study visit.
Gait characteristics will be assessed during walking trials under each study condition and compared between the textured and smooth insole conditions.
Baseline and immediately following completion of each intervention condition during the study visit.
Change in Plantar Sensation
Time Frame: Baseline and immediately following completion of each intervention condition during the study visit.
Plantar sensation will be assessed with the Semmes-Weinstein monofilaments. The detection threshold will be the lightest weight monofilament (grams of force (gf)) that can be perceived by the participant. Lower values indicate better plantar sensation.
Baseline and immediately following completion of each intervention condition during the study visit.
Change in Pressure-Pain Threshold
Time Frame: Baseline and immediately following completion of each intervention condition during the study visit.
Pressure-pain threshold will be assessed with an algometer. The pressure-pain threshold will be measured in kg/cm2. Higher values indicate better pressure-pain threshold.
Baseline and immediately following completion of each intervention condition during the study visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jennifer Xu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 118998

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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