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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Barefoot Walking Programme | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the baseline assessment (Week 0) until end of intervention (Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Function | 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) |
| Adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South East Technological University | Recruiting | Carlow | Carlow County | R93 V960 | Ireland |
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| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
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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.
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| Standardised Conservative Care | Behavioral | 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 |
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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) | 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 | 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. |