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Идёт набор NCT06996444

Evaluation of a Foot Health Program Incorporating Minimalist Footwear on Fall Risk Factors in Older People Living in Senior Nursing Homes: a Pilot Study.

Без фазы С лечением Fall Prevention

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: Program Including Various Workshops aiming to preserve elderly's autonomy through foot health.
Кому может быть актуально
Состояния в реестре: Fall Prevention. Базовые параметры: от 65 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Évaluation d'un Programme de santé du Pied Incorporant Des Chaussures Minimalistes Sur Les Facteurs de Risque de Chute Chez Des Personnes âgées Vivant en EHPAD : Une étude Pilote

Обзор

Every year in France, 2 million falls by people over 65 are responsible for 10,000 deaths, the leading cause of accidental death, and more than 130,000 hospitalizations. The main objective of this study is to evaluate the evolution of mobility in older people living in nursing homes, following 12 foot health workshops, carried out by a health professional, including the wearing of minimalist shoes.

Подробное описание

The program is divided into 3 parts :

1. Foot preparation phase (1st to 3rd week): Study participants will receive one individual session per week of plantar massage (approximately 10 min massage), combined with foot stimulation exercises. 2. Transition phase (weeks 4 to 6): Study participants will benefit from a workshop of around 1 hr per week focusing on foot mobility, posture and walking. Minimalist shoes will be introduced and certain exercises will be performed with them. The shoes will be given to participants free of charge. 3. Stabilization phase (weeks 7 to 12): Study participants will benefit from the same foot health workshops with minimalist shoes. The shoes will also be left with the participants outside the workshops, so that they can use them independently.

Вмешательства

  • Другое Program Including Various Workshops aiming to preserve elderly's autonomy through foot health
    Combination of minimalist footwear, foot massages, and workshops to re-learn walking and posture

Первичные конечные точки

  • the evolution of mobility [Срок оценки: Before and immediatly after the program]
Вторичные конечные точки (8)
  • The distance of the center of gravity from the center [Срок оценки: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention]
  • Strength of the toes [Срок оценки: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention]
  • Ankle joint amplitudes in dorsal flexion and plantar extension [Срок оценки: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention]
  • Fear of falling [Срок оценки: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention]
  • Pain felt in the feet during ambulation [Срок оценки: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention]
  • Participants' satisfaction with the minimalist shoes [Срок оценки: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention]
  • Number of hours shoes used [Срок оценки: Immediately after intervention and 12 weeks after the end of the intervention]
  • Fall [Срок оценки: Immediately after intervention and 12 weeks after the end of the intervention]

Критерии участия

Критерии включения

  • People over 65 years of age
  • Able to walk independently with or without a walking aid (cane, walker, etc.)
  • Persons affiliated with a social security system or assimilated
  • Persons (participants, guardians, or curators where applicable) who have been informed and have given their written consent to participate in the study.

Критерии исключения

  • People who already wear minimalist shoes.
  • People with a contraindication to wearing minimalist shoes
  • People wearing orthopedic shoes prescribed by a health professional.
  • People taking part in a falls prevention program.
  • Persons unable to walk
  • Persons with any other contraindication at the investigator's discretion

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Франция · 5 центров
  • Ehpad les Cèdres — Beaux
  • Ehpad Paradis — Espaly-Saint-Marcel
  • Ehpad Le Vergé de Léa — Le Puy-en-Velay
  • Ehpad Nazareth — Le Puy-en-Velay
  • Ehpad Saint Joseph — Le Puy-en-Velay

Идентификаторы

NCT: NCT06996444 · RIPH2-FUNDENBERGER-GRAND'PAS · 2025-A00124-45

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗