Preserving Autonomy Through Foot Health: a Study on the Acceptability of a Program Including Various Workshops for the Elderly (MINIPAS)

August 21, 2024 updated by: Centre Hospitalier Emile Roux

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beaulieu, France, 43800
        • EHPAD "Foyer Notre-Dame"
      • Brives-Charensac, France, 43700
        • EHPAD "Vert-Bocage"
      • Le Puy En Velay, France, 43000
        • Ssiad " Amadom43 "
      • Le Puy-en-Velay, France, 43000
        • EHPAD Nazareth
      • Vals Pres Le Puy, France, 43750
        • EHPAD Foyer " Saint-Dominique "

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Workshops aiming to preserve elderly's autonomy 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. They will also be available to participants outside the workshops for the duration of the study.
Combination of minimalist footwear, foot massages, and workshops to re-learn walking and posture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The acceptability of foot health workshops conducted by a podiatrist with elderly people
Time Frame: At the end of the 12 weeks program
Participant acceptability will be assessed by workshop attendance rates.
At the end of the 12 weeks program

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot Length measurement
Time Frame: Before and immediately after the intervention
In centimeters (cm)
Before and immediately after the intervention
The distance of the center of gravity from the center
Time Frame: Before and immediately after the intervention
Thanks to the stabilometry platform
Before and immediately after the intervention
Measurement of bearing surface and force distribution in static position
Time Frame: Before and immediately after the intervention
Thanks to the stabilometry platform
Before and immediately after the intervention
Joint capacity for ankle flexion and extension
Time Frame: Before and immediately after the intervention
Measured by the Weight-Bearing Lunge Test
Before and immediately after the intervention
Fear of falling scale
Time Frame: Before and immediately after the intervention
Numerical scale from 0 to 10 (0 meaning no fear and 10 the worst fear imaginable)
Before and immediately after the intervention
The risk of falling
Time Frame: Before and immediately after the intervention
Timed up and go test
Before and immediately after the intervention
Foot pain scale
Time Frame: Before and immediately after the intervention
Numerical scale from 0 to 10 (0 meaning no pain and 10 the worst pain imaginable)
Before and immediately after the intervention
Number and type of foot disorders
Time Frame: Before and immediately after the intervention
Before and immediately after the intervention
Number of hours shoes used
Time Frame: Immediately after the intervention
Immediately after the intervention
A specifically made satisfaction questionnaire
Time Frame: Immediately after the intervention
To evaluate participants' perception of the minimalist footwear and the various workshops (foot massage and walking)
Immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

May 14, 2024

First Posted (Actual)

May 20, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • RIPH2-FUNDENBERGER-MINIPAS
  • 2024-A00086-41 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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