Comparison of FEETME® Soles and GAITRITE® Walkway for the Evaluation of Gait Disorders in CIDP. (ESCAL-PIDC)

Study of Connected Soles With Pressure Sensors in the Evaluation of Gait Disorders in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

Chronic Inflammatory Demyelinating Polyneuropathies (CIDP) are acquired, autoimmune and inflammatory neuropathies leading mainly to gait disorders in patients. Assessment of gait disorders is a major component of therapeutic management, but evaluation is sometimes difficult due to the fluctuating nature of the symptoms. The principal objective of this study is to compare the walking speed of patients with a reference method (GAITRITE® walkway) and an innovative one (FEETME® connected soles) with the aim of validating the use of theses connected soles in CIDP gait disorders evaluation.

Study Overview

• Status: Recruiting
• Conditions: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
• Intervention / Treatment: Other: Clinical examination; Other: Functional scales; Diagnostic test: Walking test

Detailed Description

Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) present multifactorial gait disorders (motor deficit, fatigability, sensory and proprioceptive disorders with ataxia). Gait disorders are the main cause of disability in these patients. Assessment of gait disorders is a major component of therapeutic management, but evaluation is sometimes difficult due to the fluctuating nature of the symptoms. For many patients, there is indeed a fluctuating nature of gait disorders depending on the administration of treatments (reappearance of symptoms between two immunoglobulin -IgIV- infusions) conditioning the interval of two infusions. In the context of a shortage of IgIV and given the high cost of this treatment, it is of major importance to adapt the treatment as closely as possible to the needs of the patients.

Objective evaluation methods of gait disorders used in current practice have several drawbacks: chronophagy, operator-dependency, heterogeneity of data, implementation in hospital. Moreover, these methods often lack sensitivity to detect some changes. Portable evaluation methods with pressure sensors (including FEETME® connected soles) have been developed and studied in several neurological pathologies. These systems allow one-off evaluations with standardised tests but also continuous monitoring in an ecological environmentBy comparing several walk parameters with a reference method (GAITRITE® walkway) and an innovative one (FEETME® connected soles) , we want to validate the use of the connected soles in gait dirorders evaluation for CIDP patients.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Louise DEBERGE, Dr; Phone Number: 033 05 57 82 13 80; Email: louise.deberge@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France, 33000
    • Recruiting
    • Pellegrin Hospital
    • Contact: Louise DEBERGE, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients of both sexes, aged 18 to 75 years old.
• Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) defined or probable according to the EFNS/PNS (European Federation of Neurological Societies/Peripheral Nerve Society) diagnostic criteria proposed in 2010.
• Patients treated with intravenous polyvalent immunoglobulins.
• Patients with gait impairment related to CIDP, not requiring technical assistance, with an ONLS (Overall Neuropathy Limitations Scale) score of 1 or 2/7 on the lower limbs at inclusion.
• Patients affiliated to or benefiting from a social security scheme.
• Patients giving their free and informed consent to participate after information about the research.

Exclusion Criteria:

• Pregnant or breastfeeding women.
• Patients placed under guardianship, curatorship or safeguard of justice.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Connected soles; FEETME® connected tool	Other: Clinical examination; Cinical examination carried out during a consultation for the follow-up of the patient; Other: Functional scales; The Clinical scales are as follows : MRC (Medical Research Scale), ONLS (Overall Neuropathy Limitations Scale), R-ODS (Rasch-built Overall Disability Scale) , INCAT (Inflammatory Neuropathy Cause and Treatment) The functional scales are used as part of the usual care of the patient in the neurology department; Diagnostic test: Walking test; Walking test over 10 metres at a comfortable speed on the GAITRITE® walkway, fitted with FEETME® soles at the same time. The 10-metre test will be repeated 5 times, with a 2-minute break between each test.
Other: Treadmill; Reference system the GAITRite® walkway	Other: Clinical examination; Cinical examination carried out during a consultation for the follow-up of the patient; Other: Functional scales; The Clinical scales are as follows : MRC (Medical Research Scale), ONLS (Overall Neuropathy Limitations Scale), R-ODS (Rasch-built Overall Disability Scale) , INCAT (Inflammatory Neuropathy Cause and Treatment) The functional scales are used as part of the usual care of the patient in the neurology department; Diagnostic test: Walking test; Walking test over 10 metres at a comfortable speed on the GAITRITE® walkway, fitted with FEETME® soles at the same time. The 10-metre test will be repeated 5 times, with a 2-minute break between each test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validy of gait velocity	To determine the validy of gait velocity in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) patients, measured by FEETME® connected soles vs reference system the GAITRite® walkway.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step length	To compare the step length,in the 10 meters walking test obtained by the FEETME® tool and the GAITRITE® walkway in patients with CIDP in a series of 5 tests.	Day 0
Pitch attack ratio (heel/toe)	To compare the pitch attack ratio (heel/toe) in the 10 meters walking test obtained by the FEETME® tool and the GAITRITE® walkway in patients with CIDP in a series of 5 tests.	Day 0
Heel pressure measurements	To compare the heel pressure measurements in the 10 meters walking test obtained by the FEETME® tool and the GAITRITE® walkway in patients with CIDP in a series of 5 tests.	Day 0
Walking pace	To compare the he walking pace in the 10 meters walking test obtained by the FEETME® tool and the GAITRITE® walkway in patients with CIDP in a series of 5 tests.	Day 0

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Louise DEBERGE, Dr, Université Hospital, Bordeaux; Principal Investigator: Jean René CAZALETS, INCIA - Unité CNRS UMR5287_University of Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2023
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: August 5, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Inflammatory Demyelinating Polyneuropathy; FEETME® connected soles; Gait disorders evaluation
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyradiculoneuropathy; Polyneuropathies; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
• Other Study ID Numbers: CHUBX 2022/04

Drug and device information, study documents

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