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Идёт набор NCT07600229

Barefoot Walking VS Standardised Conservative Care for Plantar Fasciopathy

Без фазы С лечением Plantar Fasciopathy Plantar Fasciitis Plantar Fasciitis, Chronic Heel Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Barefoot Walking Programme, Standardised Conservative Care.
Кому может быть актуально
Состояния в реестре: Plantar Fasciopathy, Plantar Fasciitis, Plantar Fasciitis, Chronic, Heel Pain. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Ирландия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Clinical and Economic Effectiveness of Barefoot Walking Compared to Standardised Conservative Care for the Treatment of Plantar Fasciopathy: a Pragmatic Randomised Controlled Trial

Обзор

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

Вмешательства

  • Поведенческое Barefoot Walking Programme
    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.
  • Поведенческое Standardised Conservative Care
    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

Первичные конечные точки

  • First-Step Pain [Срок оценки: From the baseline assessment (Week 0) until end of intervention (Week 12)]
Вторичные конечные точки (4)
  • Function [Срок оценки: From baseline (Week 0) until the end of intervention (Week 12)]
  • Adherence [Срок оценки: Weekly during the 12-week intervention period.]
  • Cost-Effectiveness (Incremental Cost-Effectiveness Ratio) [Срок оценки: At week 12 and at 6 months post-intervention (week 36).]
  • Adverse Events [Срок оценки: Throughout the 12-week intervention and at 2, 4, and 6 months post-intervention.]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Ирландия · 1 центр
  • South East Technological University — Carlow

Идентификаторы

NCT: NCT07600229 · SETU/REC/25/26/050

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗