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RecruitingNCT07600229Updated May 22, 2026

Barefoot Walking VS Standardised Conservative Care for Plantar Fasciopathy

An interventional study of Barefoot Walking Programme and Standardised Conservative Care in Plantar Fasciopathy, Plantar Fasciitis and Plantar Fasciitis, Chronic, sponsored by Elisabetta Brigo. Recruiting at 1 site in Ireland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Elisabetta Brigo · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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
02

Conditions studied

  • Plantar Fasciopathy
  • Plantar Fasciitis
  • Plantar Fasciitis, Chronic
  • Heel Pain

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Keywords

  • Plantar fasciopathy
  • Plantar fasciitis
  • Heel pain
  • Barefoot walking
  • Foot pain
  • Musculoskeletal
  • Physical therapy
03

In context

Fasciitis, Plantar

267 studies on the registry are indexed under Fasciitis, Plantar; 70 are open to participants now.

This study's planned enrollment of 74 is above the median of 56 across 233 interventional studies indexed under Fasciitis, Plantar.

Browse Fasciitis, Plantar studies →

Lead sponsor

This is the only study on the registry with Elisabetta Brigo as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
74 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Barefoot Walking Programme

  • Active comparator
    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.

    Behavioral: Standardised Conservative Care

Interventions

  • BehavioralBarefoot 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.

    Also known as: Barefoot walking, Barefoot locomotion

  • BehavioralStandardised 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

    Also known as: Plantar fascia stretching, Calf stretching, Foot strengthening exercises, Instrinsic Foot Muscle Strengthening

06

What researchers measure

Primary outcomes

  1. First-Step Pain

    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.

    Time frame: From the baseline assessment (Week 0) until end of intervention (Week 12)

Secondary outcomes

  1. Function

    Changes in foot function measured with the Foot Function Index (FFI). Higher scores indicate worse function.

    Time frame: From baseline (Week 0) until the end of intervention (Week 12)

  2. Adherence

    Percentage of prescribed home exercise sessions completed, recorded via participant self-report log throughout the 12-week intervention period.

    Time frame: Weekly during the 12-week intervention period.

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

    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.

    Time frame: At week 12 and at 6 months post-intervention (week 36).

  4. Adverse Events

    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.

    Time frame: Throughout the 12-week intervention and at 2, 4, and 6 months post-intervention.

07

Study locations

1 of 1 sites recruiting
  • South East Technological University
    Carlow, Carlow County R93 V960, Ireland
    • Elisabetta Brigo, PhD Researcher, MSc, BSc · Contact · c00315626@setu.ie · +39 3450498301
    • Elisabetta Brigo, PhD Researcher, MSc, Bsc · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07600229
Lead sponsor
Elisabetta Brigo
Responsible party
Elisabetta Brigo (PhD Student, South East Technological University) — Sponsor-investigator
First posted
May 20, 2026
Start date
May 7, 2026
Primary completion
Oct 31, 2027 (estimated)
Completion
Oct 31, 2027 (estimated)
Last update
May 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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