South East Technological University
Carlow, Carlow County, R93 V960, Ireland
Location status: Recruiting
Location contact
Elisabetta Brigo, PhD Researcher, MSc, BSc
CONTACT
Elisabetta Brigo, PhD Researcher, MSc, Bsc
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07600229
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
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Carlow, Carlow County, R93 V960, Ireland
Location status: Recruiting
Elisabetta Brigo, PhD Researcher, MSc, BSc
CONTACT
Elisabetta Brigo, PhD Researcher, MSc, Bsc
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: Barefoot walking, Barefoot locomotion
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: Plantar fascia stretching, Calf stretching, Foot strengthening exercises, Instrinsic Foot Muscle Strengthening
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.
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.
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.
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.
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.
Elisabetta Brigo
Other
Clinical and Economic Effectiveness of Barefoot Walking Compared to Standardised Conservative Care for the Treatment of Plantar Fasciopathy: a Pragmatic Randomised Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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