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NCT Number: NCT07600229

Barefoot Walking VS Standardised Conservative Care for Plantar Fasciopathy

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South East Technological University

Carlow, Carlow County, R93 V960, Ireland

Location status: Recruiting

Location contact

Elisabetta Brigo, PhD Researcher, MSc, BSc

CONTACT

[email protected]

+39 3450498301

Elisabetta Brigo, PhD Researcher, MSc, Bsc

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Barefoot Walking Programme

Behavioral

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.

Other names: Barefoot walking, Barefoot locomotion

Standardised Conservative Care

Behavioral

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

Other names: Plantar fascia stretching, Calf stretching, Foot strengthening exercises, Instrinsic Foot Muscle Strengthening

Primary outcomes

  1. First-Step Pain

    Time frame: 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.

Secondary outcomes

  1. Function

    Time frame: 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.

  2. Adherence

    Time frame: 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.

  3. Cost-Effectiveness (Incremental Cost-Effectiveness Ratio)

    Time frame: 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.

  4. Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Elisabetta Brigo

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 20, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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