Clinical trial NCT05492604: Comparison of FEETME® Soles and GAITRITE® Walkway for the Evaluation of Gait Disorders in CIDP.
Official title: Study of Connected Soles With Pressure Sensors in the Evaluation of Gait Disorders in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Keywords: Chronic Inflammatory Demyelinating Polyneuropathy
FEETME® connected soles
Gait disorders evaluation
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Validy of gait velocity
timeFrame: Day 0
Secondary outcomes:
measure: Step length
timeFrame: Day 0
measure: Pitch attack ratio (heel/toe)
timeFrame: Day 0
measure: Heel pressure measurements
timeFrame: Day 0
measure: Walking pace
timeFrame: Day 0
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Pellegrin Hospital
Study officials:
affiliation: Université Hospital, Bordeaux
name: Louise DEBERGE, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: INCIA - Unité CNRS UMR5287_University of Bordeaux
name: Jean René CAZALETS
role: PRINCIPAL_INVESTIGATOR
References: