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

Falling Clinical Trial

— MINIPAS  

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Falling

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