Textured Insoles to Restore Sensorimotor Function in Patients With Plantar Fasciopathy (TIRE)
12. august 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
26
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jennifer Xu, PhD
- Telefonnummer: 8593239850
- E-mail: jen.xu@uky.edu
Studiesteder
-
-
Kentucky
-
Lexington, Kentucky, Forenede Stater, 40506
- University of Kentucky - Sports Medicine Research Institute
-
Kontakt:
- Jennifer Xu, PhD
- Telefonnummer: 8593239850
- E-mail: jxu231@uky.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
A textured shoe insole designed to provide plantar sensory stimulation by increasing cutaneous input to the foot during standing and walking.
A smooth shoe insole without surface texture used as a control device for comparison with the textured insole.
|
|
Sham-komparator: 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.
|
A textured shoe insole designed to provide plantar sensory stimulation by increasing cutaneous input to the foot during standing and walking.
A smooth shoe insole without surface texture used as a control device for comparison with the textured insole.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Postural Control
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Gait Characteristics
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. juli 2027
Studieafslutning (Anslået)
1. juli 2027
Datoer for studieregistrering
Først indsendt
30. juli 2026
Først indsendt, der opfyldte QC-kriterier
12. august 2026
Først opslået (Faktiske)
14. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 118998
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .