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Textured Insoles to Restore Sensorimotor Function in Patients With Plantar Fasciopathy

NCT07765082 — Not applicable, Recruiting, 26 participants, Jennifer Xu

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RegistryNCT07765082, acronym TIRE
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: none, treatment
Enrollment26 (Estimated)
SponsorJennifer Xu (Other); collaborators: National Athletic Trainers' Association
ConditionsPlantar Fasciopathy
InterventionsTextured Insole, Smooth Insole (Other)
Datesstart 2026-09-14, primary completion 2027-07-01 (estimated), completion 2027-07-01 (estimated), first posted 2026-08-14, last updated 2026-09-24
Locations1 site in United States

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-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, movement and future studies of longer-term treatment.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Textured InsoleExperimentalOther: 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 InsoleSham comparatorOther: 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.
  • Textured Insole (Other): A textured shoe insole designed to provide plantar sensory stimulation by increasing cutaneous input to the foot during standing and walking.
  • Smooth Insole (Other): A smooth shoe insole without surface texture used as a control device for comparison with the textured insole.

+Outcome measures

Primary outcomes

  • Change in Postural Control [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.

Secondary outcomes

  • Change in Gait Characteristics [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.
  • Change in Plantar Sensation [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.
  • Change in Pressure-Pain Threshold [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.

+Eligibility

Sex: All, ages: 18 Years to 55 Years

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.

+Locations (1)

FacilityCityCountryStatus
University of Kentucky - Sports Medicine Research InstituteLexington, KentuckyUnited StatesRecruiting

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