NCT07765082

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

10 months

First QC Date

July 30, 2026

Last Update Submit

August 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and immediately following completion of each intervention condition during the study visit

Secondary Outcomes (3)

  • Change in Gait Characteristics

    Baseline and immediately following completion of each intervention condition during the study visit.

  • Change in Plantar Sensation

    Baseline and immediately following completion of each intervention condition during the study visit.

  • Change in Pressure-Pain Threshold

    Baseline and immediately following completion of each intervention condition during the study visit.

Study Arms (2)

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.

Other: Textured InsoleOther: 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.

Other: Textured InsoleOther: Smooth Insole

Interventions

A textured shoe insole designed to provide plantar sensory stimulation by increasing cutaneous input to the foot during standing and walking.

Smooth InsoleTextured Insole

A smooth shoe insole without surface texture used as a control device for comparison with the textured insole.

Smooth InsoleTextured Insole

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky - Sports Medicine Research Institute

Lexington, Kentucky, 40506, United States

Location

Central Study Contacts

Jennifer Xu, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 14, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

August 14, 2026

Record last verified: 2026-08

Locations