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

NCT06996444 | Recruiting

• 2 other identifiers: RIPH2-FUNDENBERGER-GRAND'PAS2025-A00124-45
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

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.

Conditions

Fall Prevention

Outcome Measures

Primary Outcomes (1)

• the evolution of mobility

  Timed up and go test

  Before and immediatly after the program

Secondary Outcomes (8)

• 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

• Strength of the toes

  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

• Fear of falling

  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

Study Arms (1)

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.

Other: Program Including Various Workshops aiming to preserve elderly's autonomy through foot health

Interventions

Program Including Various Workshops aiming to preserve elderly's autonomy through foot health OTHER

Combination of minimalist footwear, foot massages, and workshops to re-learn walking and posture

Workshops to improve the mobility of the older people through foot health

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Emile Roux: lead

Study Sites (5)

Ehpad les Cèdres

Beaux, 43200, France

RECRUITING

Ehpad Paradis

Espaly-Saint-Marcel, 43000, France

ACTIVE NOT RECRUITING

Ehpad Le Vergé de Léa

Le Puy-en-Velay, 43000, France

ACTIVE NOT RECRUITING

Ehpad Nazareth

Le Puy-en-Velay, 43000, France

RECRUITING

Ehpad Saint Joseph

Le Puy-en-Velay, 43000, France

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 30, 2025
• Study Start: April 7, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

FR (5)