Falls in the ElderlyCHAUSS-THERANCT07366424
Evaluating the Impact of "CHUT OTONOM®" Footwear on the Spatio-temporal Parameters of Walking and the Risk of Falls in Elderly People at High Risk of Falling.
A study testing "CHUT OTONOM®" shoes from Innothera Laboratories in people with Falls in the Elderly, run by University Hospital, Lille at 1 site in France.
Trial summary
Footwear is one of the extrinsic factors that can cause falls in older adults. Indeed, ill-fitting or worn shoes or slippers that do not support the foot properly, have slippery soles or high heels can contribute to falls. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Falls in the Elderly
- What is being tested?
- "CHUT OTONOM®" shoes from Innothera Laboratories
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2026to 7 Feb 2027
- 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
- Male or female, 65 years of age or older
- Having fallen at least once in the previous 6 months.
- Patients whose foot morphology corresponds to the sizes available in Innothera Laboratories' "CHUT OTONOM®" shoes (feet with increased volume).
- Patients able to walk 10 meters unaided, without technical or human assistance.
- Patients seen at the "Multidisciplinary Fall Assessment" day hospital at Calmette Hospital, Lille University Hospital.
- Patients who have given their consent to participate in the study (written consent form signed).
- Patients affiliated to a social health insurance scheme (beneficiaries or dependents).
Who cannot join
- Presence of a focal motor deficit in the lower limbs from neurological or orthopedic causes (e.g., hemiplegia resulting from a stroke, limb amputation, etc.).
- Inability to give informed consent
- Persons under legal protection (guardianship, curatorship, judicial protection)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Lille
Lille
François PUISIEUX,, MD,PhD, 03.20.44.46.80, rancois.puisieux@chru-lille.fr
About this study
Footwear is one of the extrinsic factors that can cause falls in older adults. Indeed, ill-fitting or worn shoes or slippers that do not support the foot properly, have slippery soles or high heels can contribute to falls. The quality of footwear is a modifiable risk factor that must be addressed to reduce the risk of falling. Therefore, examining the feet and assessing footwear are an integral part of the clinical evaluation of older adults at risk of falling, Older patients are advised to wear shoes and to limit the use of slippers or slipper socks, which do not provide adequate support for the feet and may increase the risk of falls.
In this regard, in November 2020, the French National Authority for Health (HAS) published best practice recommendations entitled "The feet of older people: medical approach and podiatric care." INNOTHERA Laboratories recently designed a new line of shoes, called CHUT OTONOM®, featuring a patented outsole whose effectiveness in terms of stability has been proven in healthy subjects.
- Conditions
- Falls in the Elderly
- Being tested
- "CHUT OTONOM®" shoes from Innothera Laboratories
- Keywords
- Fall, elderly, balance, walking, therapeutic footwear, CHUT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"CHUT OTONOM®" shoes from Innothera LaboratoriesDevice
The patient will be asked to put on, depending on the group to which they have been randomized, Sequence 1: "CHUT OTONOM®" shoes from Innothera Laboratories to perform the Timed Up and Go (TUG) test, the one-leg balance test, and the treadmill recording (GaitRite) for 5 minutes. After a 15-minute rest period, the same measurements will then be taken with their usual shoes.
"CHUT OTONOM®" shoes from Innothera LaboratoriesDevice
The patient will be asked to put on, depending on the group to which they have been randomized, Sequence 2: "Their usual shoes to perform the TUG, the one-leg stand test, and the treadmill recording (GaitRite) for 5 minutes. After a 15-minute rest period, the same measurements will then be taken with the "CHUT OTONOM®" shoes from Innothera Laboratories
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: "CHUT OTONOM®" shoes from Innothera Laboratories | Experimental | Once the patient has agreed to participate, they will be asked to put on, depending on their randomization arm (sequence):
Sequence 1: "CHUT OTONOM®" shoes from Innothera Laboratories to perform the TUG, the one-leg stand test, and the treadmill recording (GaitRite) for 5 minutes. After a 15-minute rest period, the measurements will then be taken with their usual shoes. Receives: Device: "CHUT OTONOM®" shoes from Innothera Laboratories |
| Sequence 2: Their usual shoes to perform the TUG | Active comparator | Once the patient has agreed to participate, they will be asked to put on, depending on their randomization arm (sequence):
Sequence 2: Their usual shoes to perform the TUG, the one-leg stand test, and the treadmill recording (GaitRite) for 5 minutes. After a 15-minute rest period, the measurements will then be taken with the "CHUT OTONOM®" shoes from Innothera Laboratories Receives: Device: "CHUT OTONOM®" shoes from Innothera Laboratories |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of walking speed (cm/s) using the GaitRite device under two conditions: with Innothera Laboratories' CHUT OTONOM® shoes and with the patient's usual shoes.
walking speed (centimeters/seconds)
Measured: Duration of each subject's participation: 7 days
Secondary outcomes (10)
Double support time (seconds)
Measuerd using GaitRite
Measured: Duration of each subject's participation: 7 days
Stride length (centimeters)
Measuerd using GaitRite
Measured: Duration of each subject's participation: 7 days
Stride length variability (percentage)
Measuerd using GaitRite
Measured: Duration of each subject's participation: 7 days
Cycle duration variability (percentage)
Measuerd using GaitRite
Measured: Duration of each subject's participation: 7 days
Gait asymmetry (percentage),
Measuerd using GaitRite
Measured: Duration of each subject's participation: 7 days
Timed Up and Go Test scores in single-task and dual-task conditions.
Higher scores mean a worse outcome
Measured: Duration of each subject's participation: 7 days
Shoe comfort will be evaluated using the following subjective ordinal scale: 1 very uncomfortable, 2 uncomfortable, 3 neutral, 4 comfortable, 5 very comfortable (according to Menant et al., 2008) on D1 and D7.
Shoe comfort assessed on a Likert scale from 1 to 5 on Day 1 and Day 7
Measured: Duration of each subject's participation: 7 days
The ease of putting on and taking off shoes will be evaluated using the following modified subjective ordinal scale (Menant et al., 2008): 1 very difficult, 2 difficult, 3 neutral, 4 easy, 5 very easy on D1 and D7.
Ease of putting on and taking off shoes assessed on a Likert scale from 1 to 5 on Day 1 and Day
Measured: Duration of each subject's participation: 7 days
The feeling of stability will be evaluated using the following subjective ordinal scale (Menant et al., 2008): 1 very unstable, 2 unstable, 3 neutral, 4 stable, 5 very stable on D1 and D7.
Feeling of stability assessed on a Likert scale from 1 to 5 on Day 1 and Day 7
Measured: Duration of each subject's participation: 7 days
The feeling of security will be evaluated using the following subjective ordinal scale (Menant et al., 2008): 1 always, 2 often, 3 sometimes, 4 rarely, 5 never on D1 and D7
Feeling of security assessed on a Likert scale from 1 to 5 on Day 1 and Day7
Measured: Duration of each subject's participation: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start3 Feb 2026
- Primary completion7 Feb 2027 (estimated)
- Study completion7 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Falls in the ElderlyStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- INNOTHERA Laboratories, SEED at Lille University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366424
- Sponsor's protocol ID
- 2024_0604
- Acronym
- CHAUSS-THERA
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of "CHUT OTONOM®" Footwear on the Spatio-temporal Parameters of Walking and the Risk of Falls in Elderly People at High Risk of Falling.
- ClinicalTrials.gov ID
- NCT07366424
- Acronym / sponsor ID
- CHAUSS-THERA / 2024_0604
- Conditions
- Falls in the Elderly
- Keywords
- Fall, elderly, balance, walking, therapeutic footwear, CHUT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- INNOTHERA Laboratories, SEED at Lille University Hospital
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 7 Feb 2027 (estimated)
- Study completion
- 7 Feb 2027 (estimated)
- First posted
- 26 Jan 2026 (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.
Footwear is one of the extrinsic factors that can cause falls in older adults. Indeed, ill-fitting or worn shoes or slippers that do not support the foot properly, have slippery soles or high heels can contribute to falls. The quality of footwear is a modifiable risk factor that must be addressed to reduce the risk of falling. Therefore, examining the feet and assessing footwear are an integral part of the clinical evaluation of older adults at risk of falling, Older patients are advised to wear shoes and to limit the use of slippers or slipper socks, which do not provide adequate support for the feet and may increase the risk of falls.
In this regard, in November 2020, the French National Authority for Health (HAS) published best practice recommendations entitled "The feet of older people: medical approach and podiatric care." INNOTHERA Laboratories recently designed a new line of shoes, called CHUT OTONOM®, featuring a patented outsole whose effectiveness in terms of stability has been proven in healthy subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: "CHUT OTONOM®" shoes from Innothera Laboratories | Experimental | Device: "CHUT OTONOM®" shoes from Innothera LaboratoriesOnce the patient has agreed to participate, they will be asked to put on, depending on their randomization arm (sequence): Sequence 1: "CHUT OTONOM®" shoes from Innothera Laboratories to perform the TUG, the one-leg stand test, and the treadmill recording (GaitRite) for 5 minutes. After a 15-minute rest period, the measurements will then be taken with their usual shoes. |
| Sequence 2: Their usual shoes to perform the TUG | Active comparator | Device: "CHUT OTONOM®" shoes from Innothera LaboratoriesOnce the patient has agreed to participate, they will be asked to put on, depending on their randomization arm (sequence): Sequence 2: Their usual shoes to perform the TUG, the one-leg stand test, and the treadmill recording (GaitRite) for 5 minutes. After a 15-minute rest period, the measurements will then be taken with the "CHUT OTONOM®" shoes from Innothera Laboratories |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Male or female, 65 years of age or older
- Having fallen at least once in the previous 6 months.
- Patients whose foot morphology corresponds to the sizes available in Innothera Laboratories' "CHUT OTONOM®" shoes (feet with increased volume).
- Patients able to walk 10 meters unaided, without technical or human assistance.
- Patients seen at the "Multidisciplinary Fall Assessment" day hospital at Calmette Hospital, Lille University Hospital.
Key exclusion criteria (3 listed)
- Presence of a focal motor deficit in the lower limbs from neurological or orthopedic causes (e.g., hemiplegia resulting from a stroke, limb amputation, etc.).
- Inability to give informed consent
- Persons under legal protection (guardianship, curatorship, judicial protection)
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 |
|---|---|---|
| "CHUT OTONOM®" shoes from Innothera LaboratoriesThe patient will be asked to put on, depending on the group to which they have been randomized, Sequence 1: "CHUT OTONOM®" shoes from Innothera Laboratories to perform the Timed Up and Go (TUG) test, the one-leg balance test, and the treadmill recording (GaitRite) for 5 minutes. After a 15-minute rest period, the same measurements will then be taken with their usual shoes. | Device | Sequence 1: "CHUT OTONOM®" shoes from Innothera Laboratories |
| "CHUT OTONOM®" shoes from Innothera LaboratoriesThe patient will be asked to put on, depending on the group to which they have been randomized, Sequence 2: "Their usual shoes to perform the TUG, the one-leg stand test, and the treadmill recording (GaitRite) for 5 minutes. After a 15-minute rest period, the same measurements will then be taken with the "CHUT OTONOM®" shoes from Innothera Laboratories | Device | Sequence 2: Their usual shoes to perform the TUG |
Primary outcome
Measurement of walking speed (cm/s) using the GaitRite device under two conditions: with Innothera Laboratories' CHUT OTONOM® shoes and with the patient's usual shoes.
Time frame: Duration of each subject's participation: 7 days
walking speed (centimeters/seconds)
10 secondary outcomes
Double support time (seconds)
Time frame: Duration of each subject's participation: 7 days
Stride length (centimeters)
Time frame: Duration of each subject's participation: 7 days
Stride length variability (percentage)
Time frame: Duration of each subject's participation: 7 days
Cycle duration variability (percentage)
Time frame: Duration of each subject's participation: 7 days
Gait asymmetry (percentage),
Time frame: Duration of each subject's participation: 7 days
Timed Up and Go Test scores in single-task and dual-task conditions.
Time frame: Duration of each subject's participation: 7 days
Shoe comfort will be evaluated using the following subjective ordinal scale: 1 very uncomfortable, 2 uncomfortable, 3 neutral, 4 comfortable, 5 very comfortable (according to Menant et al., 2008) on D1 and D7.
Time frame: Duration of each subject's participation: 7 days
The ease of putting on and taking off shoes will be evaluated using the following modified subjective ordinal scale (Menant et al., 2008): 1 very difficult, 2 difficult, 3 neutral, 4 easy, 5 very easy on D1 and D7.
Time frame: Duration of each subject's participation: 7 days
The feeling of stability will be evaluated using the following subjective ordinal scale (Menant et al., 2008): 1 very unstable, 2 unstable, 3 neutral, 4 stable, 5 very stable on D1 and D7.
Time frame: Duration of each subject's participation: 7 days
The feeling of security will be evaluated using the following subjective ordinal scale (Menant et al., 2008): 1 always, 2 often, 3 sometimes, 4 rarely, 5 never on D1 and D7
Time frame: Duration of each subject's participation: 7 days
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 14 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "CHUT OTONOM®" shoes from Innothera Laboratories in people with Falls in the Elderly, run by University Hospital, Lille at 1 site 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 7 inclusion and 3 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact François PUISIEUX,, MD,PhD (03.20.44.46.80, francois.puisieux@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of walking speed (cm/s) using the GaitRite device under two conditions: with Innothera Laboratories' CHUT OTONOM® shoes and with the patient's usual shoes. (time frame: Duration of each subject's participation: 7 days). 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 14 May 2026.