Skip to main content
OpenTrials
Recruiting

NCT Number: 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.

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ehpad les Cèdres, Beaux, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. the evolution of mobility

    Time frame: Before and immediatly after the program

    Timed up and go test

Secondary outcomes

  1. 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

    The stabilometry platform

  2. Strength of the toes

    Time frame: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention

    By dynamometer

  3. 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

    With a goniometer

  4. Fear of falling

    Time frame: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention

    Numerical scale from 0 to 10

  5. 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

    Numerical scale from 0 to 10

  6. 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

    Questionnaire

  7. Number of hours shoes used

    Time frame: Immediately after intervention and 12 weeks after the end of the intervention

    Questionnaire

  8. Fall

    Time frame: Immediately after intervention and 12 weeks after the end of the intervention

    Questionnaire

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Emile Roux

Other

Registry information

Official study 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

Acronym: GRAND'PAS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 30, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.