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

University Hospital of Bordeaux

Status: Completed

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Treatments: Other: Clinical examination; Diagnostic Test: Walking test; Other: Functional scales

Study type: Interventional

Funder types: Other

Identifiers

NCT05492604

CHUBX 2022/04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Connected soles

Experimental group

Description:

FEETME® connected tool

Treatment:

Other: Functional scales

Diagnostic Test: Walking test

Other: Clinical examination

Treadmill

Other group

Description:

Reference system the GAITRite® walkway

Treatment:

Other: Functional scales

Diagnostic Test: Walking test

Other: Clinical examination