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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06996444
Acronym
GRAND'PAS
Enrollment
50
Registered
2025-05-30
Start date
2025-04-07
Completion date
2026-07-01
Last updated
2025-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fall 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, 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

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

Sponsors

Centre Hospitalier Emile Roux
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
the evolution of mobilityBefore and immediatly after the programTimed up and go test

Secondary

MeasureTime frameDescription
Strength of the toesBefore the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the interventionBy dynamometer
Ankle joint amplitudes in dorsal flexion and plantar extensionBefore the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the interventionWith a goniometer
Fear of fallingBefore the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the interventionNumerical scale from 0 to 10
The distance of the center of gravity from the centerBefore the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the interventionThe stabilometry platform
Participants' satisfaction with the minimalist shoesBefore the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the interventionQuestionnaire
Number of hours shoes usedImmediately after intervention and 12 weeks after the end of the interventionQuestionnaire
FallImmediately after intervention and 12 weeks after the end of the interventionQuestionnaire
Pain felt in the feet during ambulationBefore the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the interventionNumerical scale from 0 to 10

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026