Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)ESCAL-PIDCNCT05492604
Comparison of FEETME® Soles and GAITRITE® Walkway for the Evaluation of Gait Disorders in CIDP.
A study testing Clinical examination, Functional scales and Walking test in people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), run by University Hospital, Bordeaux at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- What is being tested?
- Clinical examination, Functional scales and Walking test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2023to 18 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant or breastfeeding women.
- Patients placed under guardianship, curatorship or safeguard of justice.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Connected Soles With Pressure Sensors in the Evaluation of Gait Disorders in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
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.
Read the 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.
- Being tested
- Clinical examination, Functional scales, Walking test
- Keywords
- Chronic Inflammatory Demyelinating Polyneuropathy, FEETME® connected soles, Gait disorders evaluation
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examinationOther
Cinical examination carried out during a consultation for the follow-up of the patient
Functional scalesOther
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
Walking testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Connected soles | Experimental | FEETME® connected tool Receives: Other: Clinical examination; Other: Functional scales; Diagnostic Test: Walking test |
| Treadmill | Other | Reference system the GAITRite® walkway Receives: Other: Clinical examination; Other: Functional scales; Diagnostic Test: Walking test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (4)
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start23 Mar 2023
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
Why it stopped: Target number of inclusion not reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Studies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louise DEBERGE, Dr, Principal investigator, Université Hospital, BordeauxJean René CAZALETS, Principal investigator, INCIA - Unité CNRS UMR5287_University of Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492604
- Sponsor's protocol ID
- CHUBX 2022/04
- Acronym
- ESCAL-PIDC
- Status last verified
- Jun 2025
- First submitted
- 3 Aug 2022
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Connected Soles With Pressure Sensors in the Evaluation of Gait Disorders in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
- ClinicalTrials.gov ID
- NCT05492604
- Acronym / sponsor ID
- ESCAL-PIDC / CHUBX 2022/04
- Keywords
- Chronic Inflammatory Demyelinating Polyneuropathy, FEETME® connected soles, Gait disorders evaluation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Target number of inclusion not reached
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connected soles | Experimental | Other: Clinical examination, Other: Functional scales, Diagnostic Test: Walking testFEETME® connected tool |
| Treadmill | Other | Other: Clinical examination, Other: Functional scales, Diagnostic Test: Walking testReference system the GAITRite® walkway |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding women.
- Patients placed under guardianship, curatorship or safeguard of justice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical examinationCinical examination carried out during a consultation for the follow-up of the patient | Other | Connected soles, Treadmill |
| Functional scalesThe 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 | Other | Connected soles, Treadmill |
| Walking testWalking 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. | Diagnostic test | Connected soles, Treadmill |
Primary outcome
Validy of gait velocity
Time frame: 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.
4 secondary outcomes
Step length
Time frame: Day 0
Pitch attack ratio (heel/toe)
Time frame: Day 0
Heel pressure measurements
Time frame: Day 0
Walking pace
Time frame: Day 0
Results and safety
The study was stopped early (reason given: Target number of inclusion not reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise DEBERGE, Dr principal investigator
Université Hospital, Bordeaux
Jean René CAZALETS principal investigator
INCIA - Unité CNRS UMR5287_University of Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical examination, Functional scales and Walking test in people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Target number of inclusion not reached). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validy of gait velocity (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.