Comparison of FEETME® Soles and GAITRITE® Walkway for the Evaluation of Gait Disorders in CIDP.

Not Applicable

Recruiting

• Conditions: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
• Interventions: Other: Clinical examination; Other: Functional scales; Diagnostic Test: Walking test

• Registration Number: NCT05492604
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-05
• Study First Posted: 2022-08-08
• Status Verified: 2023-01
• Study Start: 2023-03-23
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-30
• Primary Completion: 2024-08-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treadmill	Clinical examination	Reference system the GAITRite® walkway
Connected soles	Functional scales	FEETME® connected tool
Treadmill	Walking test	Reference system the GAITRite® walkway
Connected soles	Clinical examination	FEETME® connected tool
Connected soles	Walking test	FEETME® connected tool
Treadmill	Functional scales	Reference system the GAITRite® walkway

Primary Outcome Measures

Name	Time	Method
Validy of gait velocity	Day 0	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.

Secondary Outcome Measures

Name	Time	Method
Step length	Day 0	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.
Pitch attack ratio (heel/toe)	Day 0	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.
Walking pace	Day 0	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.
Heel pressure measurements	Day 0	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.

Trial Locations

Locations (1)

Pellegrin Hospital; 🇫🇷 Bordeaux, France