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. (CHAUSS-THERA)

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 Overview

• Status: Recruiting
• Conditions: Falls in the Elderly
• Intervention / Treatment: Device: "CHUT OTONOM®" shoes from Innothera Laboratories; Device: "CHUT OTONOM®" shoes from Innothera Laboratories

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: François PUISIEUX,, MD,PhD; Phone Number: 03.20.44.46.80; Email: francois.puisieux@chru-lille.fr

Study Locations

• France
  • Lille, France
    • Recruiting
    • CHU de Lille
    • Contact: François PUISIEUX,, MD,PhD; Phone Number: 03.20.44.46.80; Email: rancois.puisieux@chru-lille.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1: "CHUT OTONOM®" shoes from Innothera Laboratories; 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.	Device: "CHUT OTONOM®" shoes from Innothera Laboratories; 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.; Device: "CHUT OTONOM®" shoes from Innothera Laboratories; 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
Active Comparator: Sequence 2: Their usual shoes to perform the TUG; 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	Device: "CHUT OTONOM®" shoes from Innothera Laboratories; 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.; Device: "CHUT OTONOM®" shoes from Innothera Laboratories; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Duration of each subject's participation: 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Double support time (seconds)	Measuerd using GaitRite	Duration of each subject's participation: 7 days
Stride length (centimeters)	Measuerd using GaitRite	Duration of each subject's participation: 7 days
Stride length variability (percentage)	Measuerd using GaitRite	Duration of each subject's participation: 7 days
Cycle duration variability (percentage)	Measuerd using GaitRite	Duration of each subject's participation: 7 days
Gait asymmetry (percentage),	Measuerd using GaitRite	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	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	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	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	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	Duration of each subject's participation: 7 days

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: INNOTHERA Laboratories; SEED at Lille University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2026
• Primary Completion (Estimated): February 7, 2027
• Study Completion (Estimated): February 7, 2027

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Fall, elderly, balance, walking, therapeutic footwear, CHUT
• Other Study ID Numbers: 2024_0604

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No