Barefoot Walking VS Standardised Conservative Care for Plantar Fasciopathy
May 20, 2026 updated by: 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
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Carlow County
-
Carlow, Carlow County, Ireland, R93 V960
- Recruiting
- South East Technological University
-
Contact:
- Elisabetta Brigo, PhD Researcher, MSc, BSc
- Phone Number: +39 3450498301
- Email: c00315626@setu.ie
-
Principal Investigator:
- Elisabetta Brigo, PhD Researcher, MSc, Bsc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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:
|
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From the baseline assessment (Week 0) until end of intervention (Week 12)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Weekly during the 12-week intervention period.
|
|
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.
|
At week 12 and at 6 months post-intervention (week 36).
|
|
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.
|
Throughout the 12-week intervention and at 2, 4, and 6 months post-intervention.
|
|
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.
|
From baseline (Week 0) until the end of intervention (Week 12)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 7, 2026
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
October 31, 2027
Study Registration Dates
First Submitted
May 14, 2026
First Submitted That Met QC Criteria
May 14, 2026
First Posted (Actual)
May 20, 2026
Study Record Updates
Last Update Posted (Actual)
May 22, 2026
Last Update Submitted That Met QC Criteria
May 20, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SETU/REC/25/26/050
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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