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Completed

NCT Number: NCT06421623

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

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.

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Key information

Conditions

Falling

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EHPAD "Foyer Notre-Dame", Beaulieu, France

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About this study

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.

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 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

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 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.

Secondary outcomes

  1. Foot Length measurement

    Time frame: Before and immediately after the intervention

    In centimeters (cm)

  2. The distance of the center of gravity from the center

    Time frame: Before and immediately after the intervention

    Thanks to the stabilometry platform

  3. Measurement of bearing surface and force distribution in static position

    Time frame: Before and immediately after the intervention

    Thanks to the stabilometry platform

  4. Joint capacity for ankle flexion and extension

    Time frame: Before and immediately after the intervention

    Measured by the Weight-Bearing Lunge Test

  5. 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)

  6. The risk of falling

    Time frame: Before and immediately after the intervention

    Timed up and go test

  7. 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)

  8. Number and type of foot disorders

    Time frame: Before and immediately after the intervention

  9. 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)

  10. Number of hours shoes used

    Time frame: Immediately after the intervention

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Emile Roux

Other

Registry information

Official study title

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

Acronym: MINIPAS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 20, 2024
Registry last updated
Aug 22, 2024

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.

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