NCT06996444招募中不适用
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
Centre Hospitalier Emile Roux5 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年4月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- the evolution of mobility
研究概览
简要总结
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.
详细描述
The program is divided into 3 parts :
- 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.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Workshops to improve the mobility of the older people through foot health
Experimental
Study participants will benefit from a plantar massage session (5-10 min foot massage) and one posture and walking workshop per week, supervised by a trained health professional. Minimalist shoes have been purchased by the centers and used during the workshops.
干预措施: Program Including Various Workshops aiming to preserve elderly's autonomy through foot health (Other)
结局指标
主要结局
the evolution of mobility
时间窗: Before and immediatly after the program
Timed up and go test
次要结局
- Strength of the toes(Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention)
- Pain felt in the feet during ambulation(Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention)
- Fear of falling(Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention)
- Number of hours shoes used(Immediately after intervention and 12 weeks after the end of the intervention)
- Fall(Immediately after intervention and 12 weeks after the end of the intervention)
- The distance of the center of gravity from the center(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(Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention)
- Participants' satisfaction with the minimalist shoes(Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention)
研究者
研究点 (5)
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