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

Primary Purpose

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical examination
Functional scales
Walking test
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) focused on measuring Chronic Inflammatory Demyelinating Polyneuropathy, FEETME® connected soles, Gait disorders evaluation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 under guardianship or curatorship.

Sites / Locations

  • Pellegrin HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Connected soles

Treadmill

Arm Description

FEETME® connected tool

Reference system the GAITRite® walkway

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Step length
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)
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.
Heel pressure measurements
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.
Walking pace
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.

Full Information

First Posted
August 3, 2022
Last Updated
March 27, 2023
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT05492604
Brief Title
Comparison of FEETME® Soles and GAITRITE® Walkway for the Evaluation of Gait Disorders in CIDP.
Acronym
ESCAL-PIDC
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Keywords
Chronic Inflammatory Demyelinating Polyneuropathy, FEETME® connected soles, Gait disorders evaluation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Connected soles
Arm Type
Experimental
Arm Description
FEETME® connected tool
Arm Title
Treadmill
Arm Type
Other
Arm Description
Reference system the GAITRite® walkway
Intervention Type
Other
Intervention Name(s)
Clinical examination
Intervention Description
Cinical examination carried out during a consultation for the follow-up of the patient
Intervention Type
Other
Intervention Name(s)
Functional scales
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Walking test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Validy of gait velocity
Description
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.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Step length
Description
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.
Time Frame
Day 0
Title
Pitch attack ratio (heel/toe)
Description
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.
Time Frame
Day 0
Title
Heel pressure measurements
Description
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.
Time Frame
Day 0
Title
Walking pace
Description
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.
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Louise DEBERGE, Dr
Phone
05 57 82 13 80
Ext
033
Email
louise.deberge@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise DEBERGE, Dr
Organizational Affiliation
Université Hospital, Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean René CAZALETS
Organizational Affiliation
INCIA - Unité CNRS UMR5287_University of Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pellegrin Hospital
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise DEBERGE, Dr

12. IPD Sharing Statement

Learn more about this trial

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

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