## Protocol Section
### Identification Module
**NCT ID:** NCT06421623

**Acronym:** MINIPAS

**Brief Title:** Preserving Autonomy Through Foot Health: a Study on the Acceptability of a Program Including Various Workshops for the Elderly

**Official Title:** Préserver Son Autonomie Par la santé du Pied : Etude d'acceptabilité d'un Programme Incluant différents Ateliers Chez Les Personnes âgées

#### Organization Study ID Info
**ID:** RIPH2-FUNDENBERGER-MINIPAS
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Emile Roux
#### Secondary ID Infos
**Domain:** ID-RCB
**ID:** 2024-A00086-41
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-12
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre Hospitalier Emile Roux

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 investigators will combine minimalist footwear, plantar massage, and workshops to re-learn walking and posture. The main objective of this study is to verify the acceptability and feasibility of this program among the elderly.

**Detailed Description:** Study participants will benefit from a plantar massage session (5-10 min massage performed by a podiatrist) and one posture and walking workshop per week, also supervised by the podiatrist. Minimalist shoes have been purchased by the centers and used during the workshops. They will also be available to participants outside the workshops for the duration of the study.

### Conditions Module

**Conditions:**

- Falling

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 59

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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. They will also be available to participants outside the workshops for the duration of the study.

**Intervention Names:**

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

**Label:** Workshops aiming to preserve elderly's autonomy through foot health

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Workshops aiming to preserve elderly's autonomy through foot health

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

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

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Participant acceptability will be assessed by workshop attendance rates.

**Measure:** The acceptability of foot health workshops conducted by a podiatrist with elderly people

**Time Frame:** At the end of the 12 weeks program

#### Secondary Outcomes

**Description:** In centimeters (cm)

**Measure:** Foot Length measurement

**Time Frame:** Before and immediately after the intervention

**Description:** Thanks to the stabilometry platform

**Measure:** The distance of the center of gravity from the center

**Time Frame:** Before and immediately after the intervention

**Description:** Thanks to the stabilometry platform

**Measure:** Measurement of bearing surface and force distribution in static position

**Time Frame:** Before and immediately after the intervention

**Description:** Measured by the Weight-Bearing Lunge Test

**Measure:** Joint capacity for ankle flexion and extension

**Time Frame:** Before and immediately after the intervention

**Description:** Numerical scale from 0 to 10 (0 meaning no fear and 10 the worst fear imaginable)

**Measure:** Fear of falling scale

**Time Frame:** Before and immediately after the intervention

**Description:** Timed up and go test

**Measure:** The risk of falling

**Time Frame:** Before and immediately after the intervention

**Description:** Numerical scale from 0 to 10 (0 meaning no pain and 10 the worst pain imaginable)

**Measure:** Foot pain scale

**Time Frame:** Before and immediately after the intervention

**Measure:** Number and type of foot disorders

**Time Frame:** Before and immediately after the intervention

**Description:** To evaluate participants' perception of the minimalist footwear and the various workshops (foot massage and walking)

**Measure:** A specifically made satisfaction questionnaire

**Time Frame:** Immediately after the intervention

**Measure:** Number of hours shoes used

**Time Frame:** Immediately after the intervention

### Eligibility Module

**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 with a contraindication to wearing minimalist shoes
* Persons unable to participate in the various workshops
* Refusal to participate in research
* Persons under court protection
* Persons unable to walk
* Persons with any other contraindication at the investigator's discretion

**Minimum Age:** 65 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Beaulieu

**Country:** France

**Facility:** EHPAD "Foyer Notre-Dame"

**Zip:** 43800

**Location 2:**

**City:** Brives-Charensac

**Country:** France

**Facility:** EHPAD "Vert-Bocage"

**Zip:** 43700

**Location 3:**

**City:** Le Puy En Velay

**Country:** France

**Facility:** Ssiad " Amadom43 "

**Zip:** 43000

**Location 4:**

**City:** Le Puy-en-Velay

**Country:** France

**Facility:** Ehpad Nazareth

**Zip:** 43000

**Location 5:**

**City:** Vals Pres Le Puy

**Country:** France

**Facility:** EHPAD Foyer " Saint-Dominique "

**Zip:** 43750

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
