NCT06421623

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2024

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

March 12, 2024

Last Update Submit

August 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The acceptability of foot health workshops conducted by a podiatrist with elderly people

    Participant acceptability will be assessed by workshop attendance rates.

    At the end of the 12 weeks program

Secondary Outcomes (10)

  • Foot Length measurement

    Before and immediately after the intervention

  • The distance of the center of gravity from the center

    Before and immediately after the intervention

  • Measurement of bearing surface and force distribution in static position

    Before and immediately after the intervention

  • Joint capacity for ankle flexion and extension

    Before and immediately after the intervention

  • Fear of falling scale

    Before and immediately after the intervention

  • +5 more secondary outcomes

Study Arms (1)

Workshops aiming to preserve elderly's autonomy through foot health

EXPERIMENTAL

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.

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

Interventions

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

Workshops aiming to preserve elderly's autonomy through foot health

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

EHPAD "Foyer Notre-Dame"

Beaulieu, 43800, France

Location

EHPAD "Vert-Bocage"

Brives-Charensac, 43700, France

Location

Ehpad Nazareth

Le Puy-en-Velay, 43000, France

Location

Ssiad " Amadom43 "

Le Puy-en-Velay, 43000, France

Location

EHPAD Foyer " Saint-Dominique "

Vals-près-le-Puy, 43750, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2024

First Posted

May 20, 2024

Study Start

April 1, 2024

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

August 22, 2024

Record last verified: 2024-08

Locations