Textured Insoles to Restore Sensorimotor Function in Patients With Plantar Fasciopathy (TIRE)
12 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
26
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Jennifer Xu, PhD
- Telefonnummer: 8593239850
- E-post: jen.xu@uky.edu
Studieorter
-
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40506
- University of Kentucky - Sports Medicine Research Institute
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Kontakt:
- Jennifer Xu, PhD
- Telefonnummer: 8593239850
- E-post: jxu231@uky.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
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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.
|
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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.
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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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Postural Control
Tidsram: 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
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Gait Characteristics
Tidsram: 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.
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Baseline and immediately following completion of each intervention condition during the study visit.
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Change in Plantar Sensation
Tidsram: Baseline and immediately following completion of each intervention condition during the study visit.
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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.
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Baseline and immediately following completion of each intervention condition during the study visit.
|
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Change in Pressure-Pain Threshold
Tidsram: Baseline and immediately following completion of each intervention condition during the study visit.
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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.
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Baseline and immediately following completion of each intervention condition during the study visit.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 juli 2027
Avslutad studie (Beräknad)
1 juli 2027
Studieregistreringsdatum
Först inskickad
30 juli 2026
Först inskickad som uppfyllde QC-kriterierna
12 augusti 2026
Första postat (Faktisk)
14 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 118998
Läkemedels- och apparatinformation, studiedokument
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