FallingMINIPASNCT06421623
Preserving Autonomy Through Foot Health: a Study on the Acceptability of a Program Including Various Workshops for the Elderly
A study testing Program Including Various Workshops aiming to preserve elderly's autonomy through foot health in people with Falling, run by Centre Hospitalier Emile Roux at 5 sites in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Falling
- What is being tested?
- Program Including Various Workshops aiming to preserve elderly's autonomy through foot health
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Apr 2024to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
EHPAD "Foyer Notre-Dame"
Beaulieu, 43800
EHPAD "Vert-Bocage"
Brives-Charensac, 43700
Ehpad Nazareth
Le Puy-en-Velay, 43000
Ssiad " Amadom43 "
Le Puy-en-Velay, 43000
EHPAD Foyer " Saint-Dominique "
Vals-près-le-Puy, 43750
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Falling
- Being tested
- Program Including Various Workshops aiming to preserve elderly's autonomy through foot health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program Including Various Workshops aiming to preserve elderly's autonomy through foot healthOther
Combination of minimalist footwear, foot massages, and workshops to re-learn walking and posture
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Program Including Various Workshops aiming to preserve elderly's autonomy through foot health |
What is being measured
The primary outcome is the main question the study is designed to answer.
The acceptability of foot health workshops conducted by a nurse with elderly people
Participant acceptability will be assessed by workshop attendance rates.
Measured: At the end of the 12 weeks program
Secondary outcomes (10)
Foot Length measurement
In centimeters (cm)
Measured: Before and immediately after the intervention
The distance of the center of gravity from the center
Thanks to the stabilometry platform
Measured: Before and immediately after the intervention
Measurement of bearing surface and force distribution in static position
Thanks to the stabilometry platform
Measured: Before and immediately after the intervention
Joint capacity for ankle flexion and extension
Measured by the Weight-Bearing Lunge Test
Measured: Before and immediately after the intervention
Fear of falling scale
Numerical scale from 0 to 10 (0 meaning no fear and 10 the worst fear imaginable)
Measured: Before and immediately after the intervention
The risk of falling
Timed up and go test
Measured: Before and immediately after the intervention
Foot pain scale
Numerical scale from 0 to 10 (0 meaning no pain and 10 the worst pain imaginable)
Measured: Before and immediately after the intervention
Number and type of foot disorders
Measured: Before and immediately after the intervention
A specifically made satisfaction questionnaire
To evaluate participants' perception of the minimalist footwear and the various workshops (foot massage and walking)
Measured: Immediately after the intervention
Number of hours shoes used
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Apr 2024
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FallingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Emile Roux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421623
- Sponsor's protocol ID
- RIPH2-FUNDENBERGER-MINIPAS
- Other IDs
- 2024-A00086-41
- Acronym
- MINIPAS
- Status last verified
- Nov 2026
- First submitted
- 12 Mar 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fundenberger H, Mathieu M, Lengagne S, Gadea E. Feasibility and preliminary efficacy of a foot health program including minimalist footwear for older adults. Geriatr Nurs. 2026 Oct;73:104215. doi: 10.1016/j.gerinurse.2026.104215. Epub 2026 Aug 6.
PubMed 42561826
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Préserver Son Autonomie Par la santé du Pied : Etude d'acceptabilité d'un Programme Incluant différents Ateliers Chez Les Personnes âgées
- ClinicalTrials.gov ID
- NCT06421623
- Acronym / sponsor ID
- MINIPAS / RIPH2-FUNDENBERGER-MINIPAS
- Conditions
- Falling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Centre Hospitalier Emile RouxUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Workshops aiming to preserve elderly's autonomy through foot health | Experimental | Other: Program Including Various Workshops aiming to preserve elderly's autonomy through foot healthStudy 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Program Including Various Workshops aiming to preserve elderly's autonomy through foot healthCombination of minimalist footwear, foot massages, and workshops to re-learn walking and posture | Other | Workshops aiming to preserve elderly's autonomy through foot health |
Primary outcome
The acceptability of foot health workshops conducted by a nurse with elderly people
Time frame: At the end of the 12 weeks program
Participant acceptability will be assessed by workshop attendance rates.
10 secondary outcomes
Foot Length measurement
Time frame: Before and immediately after the intervention
The distance of the center of gravity from the center
Time frame: Before and immediately after the intervention
Measurement of bearing surface and force distribution in static position
Time frame: Before and immediately after the intervention
Joint capacity for ankle flexion and extension
Time frame: Before and immediately after the intervention
Fear of falling scale
Time frame: Before and immediately after the intervention
The risk of falling
Time frame: Before and immediately after the intervention
Foot pain scale
Time frame: Before and immediately after the intervention
Number and type of foot disorders
Time frame: Before and immediately after the intervention
A specifically made satisfaction questionnaire
Time frame: Immediately after the intervention
Number of hours shoes used
Time frame: Immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Results publication: PubMed 42561826Fundenberger H, Mathieu M, Lengagne S, Gadea E. Feasibility and preliminary efficacy of a foot health program including minimalist footwear for older adults. Geriatr Nurs. 2026 Oct;73:104215. doi: 10.1016/j.gerinurse.2026.104215. Epub 2026 Aug 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program Including Various Workshops aiming to preserve elderly's autonomy through foot health in people with Falling, run by Centre Hospitalier Emile Roux at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The acceptability of foot health workshops conducted by a nurse with elderly people (time frame: At the end of the 12 weeks program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06421623, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.