NCT07600229

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
May 2026Oct 2027

Study Start

First participant enrolled

May 7, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

1.5 years

First QC Date

May 14, 2026

Last Update Submit

May 14, 2026

Conditions

Plantar FasciopathyPlantar FasciitisPlantar Fasciitis, ChronicHeel Pain

Keywords

Plantar fasciopathyPlantar fasciitisHeel painBarefoot walkingFoot painMusculoskeletalPhysical therapy

Outcome Measures

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)

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

Secondary Outcomes (4)

  • Function

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

  • Adherence

    Weekly during the 12-week intervention period.

  • Cost-Effectiveness (Incremental Cost-Effectiveness Ratio)

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

  • Adverse Events

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

Study Arms (2)

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.

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.

Behavioral: Standardised Conservative Care

Interventions

Barefoot Walking ProgrammeBEHAVIORAL

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
Barefoot Walking
Standardised Conservative CareBEHAVIORAL

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
Standardised Conservative Care

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South East Technological University

Carlow, Carlow County, R93 V960, Ireland

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the interventions (home-based exercise programmes), blinding of participants and the care provider was not feasible. The investigator analysing the outcome data will be blinded to group allocation during data analysis.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

May 14, 2026

First Posted

May 20, 2026

Study Start

May 7, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)