Clinical trial 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.
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fall Prevention
Lead sponsor: Centre Hospitalier Emile Roux
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 (EHPAD), 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.

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

Primary outcomes:
measure: the evolution of mobility
timeFrame: Before and immediatly after the program
Secondary outcomes:
measure: The distance of the center of gravity from the center
timeFrame: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention
measure: Strength of the toes
timeFrame: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention
measure: Ankle joint amplitudes in dorsal flexion and plantar extension
timeFrame: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention
measure: Fear of falling
timeFrame: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention
measure: Pain felt in the feet during ambulation
timeFrame: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention
measure: Participants' satisfaction with the minimalist shoes
timeFrame: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention
measure: Number of hours shoes used
timeFrame: Immediately after intervention and 12 weeks after the end of the intervention
measure: Fall
timeFrame: Immediately after intervention and 12 weeks after the end of the intervention
Other outcomes:
Locations:
city: Beaux
country: France
facility: Ehpad les Cèdres
city: le Puy en Velay
country: France
facility: Ehpad Nazareth
city: Le Puy en Velay
country: France
facility: Ehpad Saint Joseph
Study officials:
References: