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

NCT ID: NCT06996444

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-07

Study Completion Date

2026-07-01

Brief Summary

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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

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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.

Conditions

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Fall Prevention

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Emile Roux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ehpad les Cèdres

Beaux, , France

Site Status RECRUITING

Ehpad Paradis

Espaly-Saint-Marcel, , France

Site Status ACTIVE_NOT_RECRUITING

Ehpad Le Vergé de Léa

Le Puy-en-Velay, , France

Site Status ACTIVE_NOT_RECRUITING

Ehpad Nazareth

Le Puy-en-Velay, , France

Site Status RECRUITING

Ehpad Saint Joseph

Le Puy-en-Velay, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Fundenberger Hervé

Role: primary

04 71 04 35 38

Fundenberger Herve

Role: primary

04 71 04 35 38

Fundenberger Hervé

Role: primary

04 71 04 35 38

Other Identifiers

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2025-A00124-45

Identifier Type: OTHER

Identifier Source: secondary_id

RIPH2-FUNDENBERGER-GRAND'PAS

Identifier Type: -

Identifier Source: org_study_id

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