Neuropathy DemyelinatingPONENCT04154540
Posturography-Neuropathy
A study testing Motion analysis in people with Neuropathy Demyelinating, run by University Hospital, Lille at 1 site in France.
Trial summary
If the classification between hereditary and acquired neuropathy is often easy, there is no completely specific marker allowing the distinction between the two etiologies. Clinical experience suggests that hereditary neuropathies have less impact on balance and gait than the acquired neuropathies at equivalent level… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathy Demyelinating
- What is being tested?
- Motion analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2021to 19 Jan 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
- CMT1A for molecular-proven Group 1 (PMP22 duplication)
- IPDC likely or defined for Group 2
- Able to walk 10 m unassisted
Who cannot join
- Neurological history other than neuropathy: epilepsy, stroke, dementia
- Pregnant women
- Person under guardianship or trusteeship
- Musculoskeletal conditions other than neuropathy impairing walking abilities
- Major comorbidity considered a contraindication by the investigator (cancer, unstable angor, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Gait and Posture in Subacute Acquired Neuropathies and in Hereditary Neuropathies
If the classification between hereditary and acquired neuropathy is often easy, there is no completely specific marker allowing the distinction between the two etiologies. Clinical experience suggests that hereditary neuropathies have less impact on balance and gait than the acquired neuropathies at equivalent level of impairment, but this has never been clearly demonstrated.
- Conditions
- Neuropathy Demyelinating
- Being tested
- Motion analysis
- Keywords
- Gait, Balance, Posture, Charcot-Marie-Tooth, Chronic inflammatory demyelinating polyneuropathy
- Medical subject headings
- Charcot-Marie-Tooth Disease, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motion analysisOther
Gait and posture recording
| Study group | Role | What they receive |
|---|---|---|
| demyelinating hereditary neuropathy | Experimental | adult patients with demyelinating hereditary neuropathy type CMT 1A. Receives: Other: Motion analysis |
| demyelinating inflammatory neuropathy | Experimental | adult patients with acquired demyelinating inflammatory neuropathy. Receives: Other: Motion analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posturography (Romberg's quotient)
Measured: Time 0 ; single session
Secondary outcomes (5)
The Timed Up and Go test (TUG)
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
the scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls
Measured: Time 0 ; single session
stride length (in millimeters) parameters
Kinematic and Kinetic parameters of the gait initiation and the stabilised gait using the optoelectronic system (VICON®)
Measured: Time 0 ; single session
stride time (in seconde) parameters
Kinematic and Kinetic parameters of the gait initiation and the stabilised gait using the optoelectronic system (VICON®)
Measured: Time 0 ; single session
velocity (meter/seconde) parameters
Kinematic and Kinetic parameters of the gait initiation and the stabilised gait using the optoelectronic system (VICON®)
Measured: Time 0 ; single session
cadence (step/min) parameters
Kinematic and Kinetic parameters of the gait initiation and the stabilised gait using the optoelectronic system (VICON®)
Measured: Time 0 ; single session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start19 May 2021
- Primary completion19 Jan 2024
- Study completion19 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathy DemyelinatingStudies of the same condition, open and under way.
- 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
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline TARD, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154540
- Sponsor's protocol ID
- 2017_17
- Other IDs
- 2017-A02861-52
- Acronym
- PONE
- Status last verified
- Dec 2025
- First submitted
- 14 Aug 2019
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dupont L, Defebvre L, Davion JB, Delval A, Tard C. Postural balance and visual dependence in patients with demyelinating neuropathies differ between acquired and hereditary etiologies. Rev Neurol (Paris). 2025 Jan-Feb;181(1-2):98-105. doi: 10.1016/j.neurol.2024.10.002. Epub 2024 Oct 28.
PubMed 39462724
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Gait and Posture in Subacute Acquired Neuropathies and in Hereditary Neuropathies
- ClinicalTrials.gov ID
- NCT04154540
- Acronym / sponsor ID
- PONE / 2017_17
- Conditions
- Neuropathy Demyelinating
- Keywords
- Gait, Balance, Posture, Charcot-Marie-Tooth, Chronic inflammatory demyelinating polyneuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 6 Nov 2019 (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.
If the classification between hereditary and acquired neuropathy is often easy, there is no completely specific marker allowing the distinction between the two etiologies. Clinical experience suggests that hereditary neuropathies have less impact on balance and gait than the acquired neuropathies at equivalent level of impairment, but this has never been clearly demonstrated.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| demyelinating hereditary neuropathy | Experimental | Other: Motion analysisadult patients with demyelinating hereditary neuropathy type CMT 1A. |
| demyelinating inflammatory neuropathy | Experimental | Other: Motion analysisadult patients with acquired demyelinating inflammatory neuropathy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CMT1A for molecular-proven Group 1 (PMP22 duplication)
- IPDC likely or defined for Group 2
- Able to walk 10 m unassisted
Key exclusion criteria (5 listed)
- Neurological history other than neuropathy: epilepsy, stroke, dementia
- Pregnant women
- Person under guardianship or trusteeship
- Musculoskeletal conditions other than neuropathy impairing walking abilities
- Major comorbidity considered a contraindication by the investigator (cancer, unstable angor, etc.)
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 |
|---|---|---|
| Motion analysisGait and posture recording | Other | demyelinating hereditary neuropathy, demyelinating inflammatory neuropathy |
Primary outcome
Posturography (Romberg's quotient)
Time frame: Time 0 ; single session
5 secondary outcomes
The Timed Up and Go test (TUG)
Time frame: Time 0 ; single session
stride length (in millimeters) parameters
Time frame: Time 0 ; single session
stride time (in seconde) parameters
Time frame: Time 0 ; single session
velocity (meter/seconde) parameters
Time frame: Time 0 ; single session
cadence (step/min) parameters
Time frame: Time 0 ; single session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Results publication: PubMed 39462724Dupont L, Defebvre L, Davion JB, Delval A, Tard C. Postural balance and visual dependence in patients with demyelinating neuropathies differ between acquired and hereditary etiologies. Rev Neurol (Paris). 2025 Jan-Feb;181(1-2):98-105. doi: 10.1016/j.neurol.2024.10.002. Epub 2024 Oct 28.
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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.
Céline TARD, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motion analysis in people with Neuropathy Demyelinating, run by University Hospital, Lille 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 11 Dec 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Posturography (Romberg's quotient) (time frame: Time 0 ; single session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04154540, which also lists 1 linked publication.
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 11 Dec 2025.