CHU de Lille
Lille, France
Location status: Recruiting
Recruiting
NCT Number: NCT07366424
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.
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
65 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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).
Exclusion criteria
- 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)
Treatment and study plan
"CHUT OTONOM®" shoes from Innothera Laboratories
DeviceThe 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.
Primary outcomes
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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)
Secondary outcomes
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Double support time (seconds)
Time frame: Duration of each subject's participation: 7 days
Measuerd using GaitRite
-
Stride length (centimeters)
Time frame: Duration of each subject's participation: 7 days
Measuerd using GaitRite
-
Stride length variability (percentage)
Time frame: Duration of each subject's participation: 7 days
Measuerd using GaitRite
-
Cycle duration variability (percentage)
Time frame: Duration of each subject's participation: 7 days
Measuerd using GaitRite
-
Gait asymmetry (percentage),
Time frame: Duration of each subject's participation: 7 days
Measuerd using GaitRite
-
Timed Up and Go Test scores in single-task and dual-task conditions.
Time frame: Duration of each subject's participation: 7 days
Higher scores mean a worse outcome
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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
Shoe comfort assessed on a Likert scale from 1 to 5 on Day 1 and Day 7
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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
Ease of putting on and taking off shoes assessed on a Likert scale from 1 to 5 on Day 1 and Day
-
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
Feeling of stability assessed on a Likert scale from 1 to 5 on Day 1 and Day 7
-
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
Feeling of security assessed on a Likert scale from 1 to 5 on Day 1 and Day7
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University Hospital, Lille
Other
Collaborators
- INNOTHERA Laboratories
- SEED at Lille University Hospital
Registry information
Acronym: CHAUSS-THERA
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jan 26, 2026
- Registry last updated
- May 14, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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