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

NCT05492604 | Completed

• 1 other identifier: CHUBX 2022/04
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Keywords

Chronic Inflammatory Demyelinating Polyneuropathy; FEETME® connected soles; Gait disorders evaluation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Step length

  Day 0

• Pitch attack ratio (heel/toe)

  Day 0

• Heel pressure measurements

  Day 0

• Walking pace

  Day 0

Study Arms (2)

Connected soles

EXPERIMENTAL

FEETME® connected tool

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

Treadmill

OTHER

Reference system the GAITRite® walkway

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

Interventions

Clinical examination OTHER

Cinical examination carried out during a consultation for the follow-up of the patient

Connected soles; Treadmill

Functional scales OTHER

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

Connected soles; Treadmill

Walking test DIAGNOSTIC_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.

Connected soles; Treadmill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 affiliated to or benefiting from a social security scheme.
• Patients giving their free and informed consent to participate after information about the research.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Pellegrin Hospital

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Louise DEBERGE, Dr

  Université Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Jean René CAZALETS

  INCIA - Unité CNRS UMR5287_University of Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 8, 2022
• Study Start: March 23, 2023
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

FR (1)