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Barefoot Walking VS Standardised Conservative Care for Plantar Fasciopathy

20. maj 2026 opdateret af: Elisabetta Brigo

Clinical and Economic Effectiveness of Barefoot Walking Compared to Standardised Conservative Care for the Treatment of Plantar Fasciopathy: a Pragmatic Randomised Controlled Trial

The goal of this clinical trial is to learn if a barefoot walking programme can treat plantar fasciopathy (heel pain) in adults aged 18-70. The main questions it aims to answer are:

  • Does a barefoot walking programme reduce heel pain compared to a standardised stretching and strengthening programme?
  • Does a barefoot walking programme improve foot function and quality of life in adults with plantar fasciopathy?

Researchers will compare a barefoot walking programme to a standardised stretching and strengthening programme to see if barefoot walking is an effective conservative management approach for plantar fasciopathy.

Participants will:

  • Be randomly assigned to either a barefoot walking programme or a stretching and strengthening programme
  • Complete a 12-week home-based exercise programme
  • Complete short weekly questionnaires throughout the 12 weeks
  • Complete 3 follow-up surveys over 6 months after the intervention ends
  • Receive education on load management and plantar fasciopathy

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

74

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Irland
    • Carlow County
      • Carlow, Carlow County, Irland, R93 V960
        • Rekruttering
        • South East Technological University
        • Kontakt:
          • Elisabetta Brigo, PhD Researcher, MSc, BSc
          • Telefonnummer: +39 3450498301
          • E-mail: c00315626@setu.ie
        • Ledende efterforsker:
          • Elisabetta Brigo, PhD Researcher, MSc, Bsc

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
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Aged 18-70 years;
  • Clinical diagnosis of Plantar Fasciopahty, defined by: a) Pain localised to the medial calcaneal tubercle of sharp or stabbing quality; b) Pain worst with the first few steps in the morning or after a period of rest (first-step pain); c) Pain reproduced with palpation of the medial calcaneal tubercle OR positive Windlass Test;
  • Symptom duration greater than 4 weeks;
  • Able to walk independently without a mobility aid
  • Able to provide informed consent and comply with study protocol

Exclusion Criteria:

  • Prior surgery on the affected foot
  • Diabetes with peripheral neuropathy or other neurological condition affecting lower limb sensation or motor control
  • Active inflammatory arthropathy, uncontrolled vascular disease, or inability to walk unaided
  • Current or recent (less than 6 months) bony stress fracture or other acute foot or ankle injury on the affected side
  • Pregnancy during the intervention period
  • BMI greater than 40 kg/m²
  • Corticosteroid injection to the affected foot within the previous 3 months
  • Night splints initiated less than 4 weeks prior to enrolment
  • Any condition that would make participation unsafe, including open foot wounds

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: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Barefoot Walking
Participants allocated to this arm will follow a structured 12-week progressive barefoot walking programme on grass completed at home. The programme involves gradually increasing the duration and frequency of barefoot walking on grass. Participants will receive education on plantar fasciopathy, load management principles, and guidance on how to progress the programme safely. Adherence and symptom response will be monitored through weekly short questionnaires.
Adfærdsmæssigt: Barefoot Walking Programme
A structured 12-week progressive home-based barefoot walking programme on grass for adults with plantar fasciopathy. Participants gradually increase the duration and frequency of barefoot walking over the 12-week period. Education on plantar fasciopathy and load management principles is provided. Adherence and symptom response are monitored via weekly questionnaires.
Andre navne:
  • Barefoot walking
  • Barefoot locomotion
Aktiv komparator: Standardised Conservative Care
Participants allocated to this arm will follow a structured 12-week standardised stretching and strengthening programme completed at home. The programme includes plantar fascia and calf stretching exercises alongside progressive foot and lower limb strengthening exercises. Participants will receive education on plantar fasciopathy and load management principles. Adherence and symptom response will be monitored through weekly short questionnaires.
Adfærdsmæssigt: Standardised Conservative Care
A structured 12-week standardised home-based stretching and strengthening programme for adults with plantar fasciopathy. The programme includes plantar fascia and calf stretching alongside progressive foot and lower limb strengthening exercises. Education on plantar fasciopathy and load management principles is provided. Adherence and symptom response are monitored via weekly questionnaires
Andre navne:
  • Plantar fascia stretching
  • Calf stretching
  • Foot strengthening exercises
  • Instrinsic Foot Muscle Strengthening

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
First-Step Pain
Tidsramme: From the baseline assessment (Week 0) until end of intervention (Week 12)
Changes in average first-step morning pain over the last 7 days measured with the Numeric Pain Rating Scale (NPRS), where 0 = no pain and 10 = worst imaginable pain.
From the baseline assessment (Week 0) until end of intervention (Week 12)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adherence
Tidsramme: Weekly during the 12-week intervention period.
Percentage of prescribed home exercise sessions completed, recorded via participant self-report log throughout the 12-week intervention period.
Weekly during the 12-week intervention period.
Cost-Effectiveness (Incremental Cost-Effectiveness Ratio)
Tidsramme: At week 12 and at 6 months post-intervention (week 36).
Incremental cost per unit of clinical improvement between groups, expressed as cost per 1-point improvement in pain (NPRS) and cost per 10% improvement in foot function (FFI). Total costs will include healthcare utilisation and participant out-of-pocket expenses. Two separate ICERs will be calculated.
At week 12 and at 6 months post-intervention (week 36).
Adverse Events
Tidsramme: Throughout the 12-week intervention and at 2, 4, and 6 months post-intervention.
Any training-related injuries, falls, skin injuries, or symptom exacerbations reported by participants throughout the study period, recorded via weekly questionnaires and follow-up surveys.
Throughout the 12-week intervention and at 2, 4, and 6 months post-intervention.
Function
Tidsramme: From baseline (Week 0) until the end of intervention (Week 12)
Changes in foot function measured with the Foot Function Index (FFI). Higher scores indicate worse function.
From baseline (Week 0) until the end of intervention (Week 12)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Elisabetta Brigo

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 (Faktiske)

7. maj 2026

Primær færdiggørelse (Anslået)

31. oktober 2027

Studieafslutning (Anslået)

31. oktober 2027

Datoer for studieregistrering

Først indsendt

14. maj 2026

Først indsendt, der opfyldte QC-kriterier

14. maj 2026

Først opslået (Faktiske)

20. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SETU/REC/25/26/050

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