- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06421623
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Beaulieu, France, 43800
- EHPAD "Foyer Notre-Dame"
-
Brives-Charensac, France, 43700
- EHPAD "Vert-Bocage"
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Le Puy En Velay, France, 43000
- Ssiad " Amadom43 "
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Le Puy-en-Velay, France, 43000
- EHPAD Nazareth
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Vals Pres Le Puy, France, 43750
- EHPAD Foyer " Saint-Dominique "
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Workshops aiming to preserve elderly's autonomy through foot health
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
Combination of minimalist footwear, foot massages, and workshops to re-learn walking and posture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At the end of the 12 weeks program
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Foot Length measurement
Time Frame: Before and immediately after the intervention
|
In centimeters (cm)
|
Before and immediately after the intervention
|
|
The distance of the center of gravity from the center
Time Frame: Before and immediately after the intervention
|
Thanks to the stabilometry platform
|
Before and immediately after the intervention
|
|
Measurement of bearing surface and force distribution in static position
Time Frame: Before and immediately after the intervention
|
Thanks to the stabilometry platform
|
Before and immediately after the intervention
|
|
Joint capacity for ankle flexion and extension
Time Frame: Before and immediately after the intervention
|
Measured by the Weight-Bearing Lunge Test
|
Before and immediately after the intervention
|
|
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)
|
Before and immediately after the intervention
|
|
The risk of falling
Time Frame: Before and immediately after the intervention
|
Timed up and go test
|
Before and immediately after the intervention
|
|
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)
|
Before and immediately after the intervention
|
|
Number and type of foot disorders
Time Frame: Before and immediately after the intervention
|
Before and immediately after the intervention
|
|
|
Number of hours shoes used
Time Frame: Immediately after the intervention
|
Immediately after the intervention
|
|
|
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)
|
Immediately after the intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RIPH2-FUNDENBERGER-MINIPAS
- 2024-A00086-41 (Other Identifier: ID-RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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