Barefoot Walking VS Standardised Conservative Care for Plantar Fasciopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorElisabetta Brigo
About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Barefoot Walking Programme
BehavioralA 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 Care
BehavioralA 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
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: Barefoot WalkingExperimental treatment 1 intervention
Group B: Standardised Conservative CareActive comparator 1 intervention
Trial outcomes
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Elisabetta Brigo
Lead sponsor
South East Technological University
Sponsor institution
Source ClinicalTrials.gov