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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06421623
Other study ID # RIPH2-FUNDENBERGER-MINIPAS
Secondary ID 2024-A00086-41
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date July 1, 2024

Study information

Verified date May 2024
Source Centre Hospitalier Emile Roux
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 59
Est. completion date July 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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

Locations

Country Name City State
France EHPAD "Foyer Notre-Dame" Beaulieu
France EHPAD "Vert-Bocage" Brives-Charensac
France Ssiad " Amadom43 " Le Puy En Velay
France Ehpad Nazareth Le Puy-en-Velay
France EHPAD Foyer " Saint-Dominique " Vals Pres Le Puy

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Emile Roux

Country where clinical trial is conducted

France, 

Outcome

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