Plantar FasciopathyNCT07600229
Barefoot Walking VS Standardised Conservative Care for Plantar Fasciopathy
A study testing Barefoot Walking Programme and Standardised Conservative Care in people with Plantar Fasciopathy and Plantar Fasciitis, run by Elisabetta Brigo at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plantar Fasciopathy, Plantar Fasciitis, Plantar Fasciitis, Chronic
- What is being tested?
- Barefoot Walking Programme and Standardised Conservative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteIreland
- Study dates
- 7 May 2026to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
South East Technological University
Carlow, Carlow County, R93 V960
Elisabetta Brigo, PhD Researcher, MSc, BSc, +39 3450498301, c00315626@setu.ie
Elisabetta Brigo, PhD Researcher, MSc, Bsc
About this study
Official title: 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?
Read more
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
- Being tested
- Barefoot Walking Programme, Standardised Conservative Care
- Keywords
- Plantar fasciopathy, Plantar fasciitis, Heel pain, Barefoot walking, Foot pain, Musculoskeletal, Physical therapy
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barefoot Walking ProgrammeBehavioural
Also called Barefoot walking, Barefoot locomotion
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.
Standardised Conservative CareBehavioural
Also called Plantar fascia stretching, Calf stretching, Foot strengthening exercises, Instrinsic Foot Muscle Strengthening
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
| Study group | Role | What they receive |
|---|---|---|
| Barefoot Walking | Experimental | 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. Receives: Behavioral: Barefoot Walking Programme |
| Standardised Conservative Care | Active comparator | 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. Receives: Behavioral: Standardised Conservative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the baseline assessment (Week 0) until end of intervention (Week 12)
Secondary outcomes (4)
Function
Changes in foot function measured with the Foot Function Index (FFI). Higher scores indicate worse function.
Measured: From baseline (Week 0) until the end of intervention (Week 12)
Adherence
Percentage of prescribed home exercise sessions completed, recorded via participant self-report log throughout the 12-week intervention period.
Measured: Weekly during the 12-week intervention period.
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.
Measured: At week 12 and at 6 months post-intervention (week 36).
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.
Measured: Throughout the 12-week intervention and at 2, 4, and 6 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start7 May 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elisabetta Brigo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elisabetta Brigo, South East Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600229
- Sponsor's protocol ID
- SETU/REC/25/26/050
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Economic Effectiveness of Barefoot Walking Compared to Standardised Conservative Care for the Treatment of Plantar Fasciopathy: a Pragmatic Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07600229
- Acronym / sponsor ID
- SETU/REC/25/26/050
- Keywords
- Plantar fasciopathy, Plantar fasciitis, Heel pain, Barefoot walking, Foot pain, Musculoskeletal, Physical therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Elisabetta BrigoUniversity, hospital or other
- Study start
- 7 May 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Barefoot Walking | Experimental | Behavioral: Barefoot Walking ProgrammeParticipants 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. |
| Standardised Conservative Care | Active comparator | Behavioral: Standardised Conservative CareParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barefoot Walking ProgrammeAlso: Barefoot walking, Barefoot locomotionA 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. | Behavioural | Barefoot Walking |
| Standardised Conservative CareAlso: Plantar fascia stretching, Calf stretching, Foot strengthening exercises, Instrinsic Foot Muscle StrengtheningA 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 | Behavioural | Standardised Conservative Care |
Primary outcome
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.
4 secondary outcomes
Function
Time frame: From baseline (Week 0) until the end of intervention (Week 12)
Adherence
Time frame: 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).
Adverse Events
Time frame: Throughout the 12-week intervention and at 2, 4, and 6 months post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
Related trials for Plantar Fasciopathy
Recruiting
Textured Insoles to Restore Sensorimotor Function in Patients With Plantar Fasciopathy
Plantar Fasciopathy
Not yet recruitingPhase 2
NAC-REPAIR for Post-surgical Pain
Carpal Tunnel Surgery, Trigger Finger Disorder
Not yet recruiting
Comparative Effectiveness of Different Neural Mobilization Techniques in Plantar Fasciitis
Plantar Fasciitis, Chronic
Not yet recruiting
Multimodal Conservative Intervention Versus Surgery for Chronic Refractory Plantar Fasciopathy
Chronic Refractory Plantar Fasciopathy
Not yet recruiting
Focused Shockwave Therapy for Plantar Fasciopathy
Plantar Fascitis, Chronic Plantar Fasciitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barefoot Walking Programme and Standardised Conservative Care in people with Plantar Fasciopathy and Plantar Fasciitis, run by Elisabetta Brigo at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-Step Pain (time frame: From the baseline assessment (Week 0) until end of intervention (Week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.