NCT06996444RecruitingNot Applicable
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 Roux10 sites in 1 country50 target enrollmentStarted: April 7, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 10
- Primary Endpoint
- the evolution of mobility
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
the evolution of mobility
Time Frame: Before and immediatly after the program
Timed up and go test
Secondary Outcomes
- 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)
Investigators
Study Sites (10)
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