Fall PreventionGRAND'PASNCT06996444
Evaluation of a Foot Health Program Incorporating Minimalist Footwear on Fall Risk Factors in Older People Living in Senior Nursing Homes: a Pilot Study.
A study testing Program Including Various Workshops aiming to preserve elderly's autonomy through foot health in people with Fall Prevention, 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 main objective of this study is to evaluate the evolution of mobility in older people living in nursing homes, following 12 foot health… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fall Prevention
- 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
- 50 participants
- Where
- 5 sitesFrance
- Study dates
- 7 Apr 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 who already wear minimalist shoes.
- People with a contraindication to wearing minimalist shoes
- People wearing orthopedic shoes prescribed by a health professional.
- People taking part in a falls prevention program.
- Persons unable to walk
- Persons with any other contraindication at the investigator's discretion
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 3 recruiting
- Recruiting
Ehpad les Cèdres
Beaux, 43200
Fundenberger Hervé, 04 71 04 35 38, hervefundenberger@ch-lepuy.fr
- Active, not recruiting
Ehpad Paradis
Espaly-Saint-Marcel, 43000
- Active, not recruiting
Ehpad Le Vergé de Léa
Le Puy-en-Velay, 43000
- Recruiting
Ehpad Nazareth
Le Puy-en-Velay, 43000
Fundenberger Herve, 04 71 04 35 38, hervefundenberger@ch-lepuy.fr
- Recruiting
Ehpad Saint Joseph
Le Puy-en-Velay, 43000
Fundenberger Hervé, 04 71 04 35 38, hervefundenberger@ch-lepuy.fr
About this study
Official title: Évaluation d'un Programme de santé du Pied Incorporant Des Chaussures Minimalistes Sur Les Facteurs de Risque de Chute Chez Des Personnes âgées Vivant en EHPAD : Une étude Pilote
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 main objective of this study is to evaluate the evolution of mobility in older people living in nursing homes, following 12 foot health workshops, carried out by a health professional, including the wearing of minimalist shoes.
Read the detailed description
The program is divided into 3 parts :
- Foot preparation phase (1st to 3rd week): Study participants will receive one individual session per week of plantar massage (approximately 10 min massage), combined with foot stimulation exercises.
- Transition phase (weeks 4 to 6): Study participants will benefit from a workshop of around 1 hr per week focusing on foot mobility, posture and walking. Minimalist shoes will be introduced and certain exercises will be performed with them. The shoes will be given to participants free of charge.
- Stabilization phase (weeks 7 to 12): Study participants will benefit from the same foot health workshops with minimalist shoes. The shoes will also be left with the participants outside the workshops, so that they can use them independently.
- Conditions
- Fall Prevention
- 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 to improve the mobility of the older people 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. 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 evolution of mobility
Timed up and go test
Measured: Before and immediatly after the program
Secondary outcomes (8)
The distance of the center of gravity from the center
The stabilometry platform
Measured: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention
Strength of the toes
By dynamometer
Measured: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention
Ankle joint amplitudes in dorsal flexion and plantar extension
With a goniometer
Measured: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention
Fear of falling
Numerical scale from 0 to 10
Measured: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention
Pain felt in the feet during ambulation
Numerical scale from 0 to 10
Measured: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention
Participants' satisfaction with the minimalist shoes
Questionnaire
Measured: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention
Number of hours shoes used
Questionnaire
Measured: Immediately after intervention and 12 weeks after the end of the intervention
Fall
Questionnaire
Measured: Immediately after intervention and 12 weeks after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start7 Apr 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall PreventionStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
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
- NCT06996444
- Sponsor's protocol ID
- RIPH2-FUNDENBERGER-GRAND'PAS
- Other IDs
- 2025-A00124-45
- Acronym
- GRAND'PAS
- Status last verified
- Jul 2025
- First submitted
- 5 May 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Primary and secondary outcomes, demographic data
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Évaluation d'un Programme de santé du Pied Incorporant Des Chaussures Minimalistes Sur Les Facteurs de Risque de Chute Chez Des Personnes âgées Vivant en EHPAD : Une étude Pilote
- ClinicalTrials.gov ID
- NCT06996444
- Acronym / sponsor ID
- GRAND'PAS / RIPH2-FUNDENBERGER-GRAND'PAS
- Conditions
- Fall Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Emile RouxUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 30 May 2025 (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 main objective of this study is to evaluate the evolution of mobility in older people living in nursing homes, following 12 foot health workshops, carried out by a health professional, including the wearing of minimalist shoes.
Detailed description
The program is divided into 3 parts :
- Foot preparation phase (1st to 3rd week): Study participants will receive one individual session per week of plantar massage (approximately 10 min massage), combined with foot stimulation exercises.
- Transition phase (weeks 4 to 6): Study participants will benefit from a workshop of around 1 hr per week focusing on foot mobility, posture and walking. Minimalist shoes will be introduced and certain exercises will be performed with them. The shoes will be given to participants free of charge.
- Stabilization phase (weeks 7 to 12): Study participants will benefit from the same foot health workshops with minimalist shoes. The shoes will also be left with the participants outside the workshops, so that they can use them independently.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Workshops to improve the mobility of the older people 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. |
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 who already wear minimalist shoes.
- People with a contraindication to wearing minimalist shoes
- People wearing orthopedic shoes prescribed by a health professional.
- People taking part in a falls prevention program.
- 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 to improve the mobility of the older people through foot health |
Primary outcome
the evolution of mobility
Time frame: Before and immediatly after the program
Timed up and go test
8 secondary outcomes
The distance of the center of gravity from the center
Time frame: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention
Strength of the toes
Time frame: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention
Ankle joint amplitudes in dorsal flexion and plantar extension
Time frame: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention
Fear of falling
Time frame: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention
Pain felt in the feet during ambulation
Time frame: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention
Participants' satisfaction with the minimalist shoes
Time frame: Before the intervention (baseline) , immediatly after the intervention, and 12 weeks following the end of the intervention
Number of hours shoes used
Time frame: Immediately after intervention and 12 weeks after the end of the intervention
Fall
Time frame: Immediately after intervention and 12 weeks after the end of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: Yes. Primary and secondary outcomes, demographic data
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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.
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 Fall Prevention, 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: looking for participants now, as of the sponsor's last update on 3 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the evolution of mobility (time frame: Before and immediatly after the program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2025.