NCT05492604

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-23
• Primary completion: 2024-06-18
• Completion: 2024-06-18
• First posted: 2022-08-08
• Last updated: 2025-06-29

Locations

1 site across 1 country: France