Evaluation of a Foot Health Program Incorporating Minimalist Footwear on Fall Risk Factors in Older People Living in Senior Nursing Homes: a Pilot Study.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Program Including Various Workshops aiming to preserve elderly's autonomy through foot health.
- Who it may be relevant to
- Registry conditions: Fall Prevention. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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 :
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.
Interventions
- Other 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
Primary outcome measures
- the evolution of mobility [Time frame: Before and immediatly after the program]
Secondary outcome measures (8)
- The distance of the center of gravity from the center [Time frame: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention]
- Strength of the toes [Time frame: 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 [Time frame: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention]
- Fear of falling [Time frame: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention]
- Pain felt in the feet during ambulation [Time frame: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention]
- Participants' satisfaction with the minimalist shoes [Time frame: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention]
- Number of hours shoes used [Time frame: Immediately after intervention and 12 weeks after the end of the intervention]
- Fall [Time frame: Immediately after intervention and 12 weeks after the end of the intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 5 centers
- 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
Identifiers
NCT: NCT06996444 · RIPH2-FUNDENBERGER-GRAND'PAS · 2025-A00124-45