Plantar FasciopathyTIRENCT07765082
Textured Insoles to Restore Sensorimotor Function in Patients With Plantar Fasciopathy
A study testing Textured Insole and Smooth Insole in people with Plantar Fasciopathy, run by Jennifer Xu at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Plantar Fasciopathy
- What is being tested?
- Textured Insole and Smooth Insole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky - Sports Medicine Research Institute
Lexington, Kentucky, 40506
Jennifer Xu, PhD, 8593239850, jxu231@uky.edu
About this study
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.
Read the 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.
- Conditions
- Plantar Fasciopathy
- Being tested
- Textured Insole, Smooth Insole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Textured InsoleOther
A textured shoe insole designed to provide plantar sensory stimulation by increasing cutaneous input to the foot during standing and walking.
Smooth InsoleOther
A smooth shoe insole without surface texture used as a control device for comparison with the textured insole.
| Study group | Role | What they receive |
|---|---|---|
| Textured Insole | Experimental | 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. Receives: Other: Textured Insole; Other: Smooth Insole |
| Smooth Insole | Sham comparator | Participants will wear a smooth (non-textured) insole while completing the same assessments to serve as the comparison condition in the crossover study. Receives: Other: Textured Insole; Other: Smooth Insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Postural Control
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.
Measured: Baseline and immediately following completion of each intervention condition during the study visit
Secondary outcomes (3)
Change in Gait Characteristics
Gait characteristics will be assessed during walking trials under each study condition and compared between the textured and smooth insole conditions.
Measured: Baseline and immediately following completion of each intervention condition during the study visit.
Change in Plantar Sensation
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.
Measured: Baseline and immediately following completion of each intervention condition during the study visit.
Change in Pressure-Pain Threshold
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.
Measured: Baseline and immediately following completion of each intervention condition during the study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start14 Sep 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jennifer Xu
- Sponsor type
- University, hospital or other
- Collaborators
- National Athletic Trainers' Association
- Responsible party
- Sponsor-investigator, Jennifer Xu, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765082
- Sponsor's protocol ID
- 118998
- Acronym
- TIRE
- Status last verified
- Sep 2026
- First submitted
- 30 Jul 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Textured Insoles to Restore Sensorimotor Function in Patients With Plantar Fasciopathy
- ClinicalTrials.gov ID
- NCT07765082
- Acronym / sponsor ID
- TIRE / 118998
- Conditions
- Plantar Fasciopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Jennifer XuUniversity, hospital or other
- Collaborators
- National Athletic Trainers' Association
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Textured Insole | Experimental | Other: Textured Insole, Other: Smooth InsoleParticipants will wear textured insoles while completing gait, postural control, and sensorimotor function assessments to evaluate the acute effects of the intervention on plantar fasciopathy. |
| Smooth Insole | Sham comparator | Other: Textured Insole, Other: Smooth InsoleParticipants will wear a smooth (non-textured) insole while completing the same assessments to serve as the comparison condition in the crossover study. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Textured InsoleA textured shoe insole designed to provide plantar sensory stimulation by increasing cutaneous input to the foot during standing and walking. | Other | Smooth Insole, Textured Insole |
| Smooth InsoleA smooth shoe insole without surface texture used as a control device for comparison with the textured insole. | Other | Smooth Insole, Textured Insole |
Primary outcome
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.
3 secondary outcomes
Change in Gait Characteristics
Time frame: 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.
Change in Pressure-Pain Threshold
Time frame: Baseline and immediately following completion of each intervention condition during the study visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Textured Insole and Smooth Insole in people with Plantar Fasciopathy, run by Jennifer Xu at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Xu, PhD (8593239850, jen.xu@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Postural Control (time frame: Baseline and immediately following completion of each intervention condition during the study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.