Preserving Autonomy Through Foot Health: a Study on the Acceptability of a Program Including Various Workshops for the Elderly
MINIPAS
Préserver Son Autonomie Par la santé du Pied : Etude d'acceptabilité d'un Programme Incluant différents Ateliers Chez Les Personnes âgées
2 other identifiers
interventional
59
1 country
5
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2024
Shorter than P25 for not_applicable
5 active sites
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
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedFirst Posted
Study publicly available on registry
May 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedAugust 22, 2024
August 1, 2024
4 months
March 12, 2024
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
EXPERIMENTALStudy 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.
Interventions
Combination of minimalist footwear, foot massages, and workshops to re-learn walking and posture
Eligibility Criteria
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
EHPAD "Vert-Bocage"
Brives-Charensac, 43700, France
Ehpad Nazareth
Le Puy-en-Velay, 43000, France
Ssiad " Amadom43 "
Le Puy-en-Velay, 43000, France
EHPAD Foyer " Saint-Dominique "
Vals-près-le-Puy, 43750, France
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