ClinicalTrials.gg
CompletedNCT04283175KPLATESUpdated Jun 4, 2025

Validation Study of Posturology Platforms for Evaluating Postural Control of Hemiparetic and Neuro-muscular Patients

An observational study in Neuromuscular Diseases, Hemiparesis and Charcot-Marie-Tooth Disease, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-04.

Primary conditionCharcot-Marie-Tooth DiseaseRegistry: Neuromuscular DiseasesReclassifiedWhy we changed it
Registry
Neuromuscular Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Charcot-Marie-Tooth Disease
Why
  1. The study's listed conditions name Charcot-Marie-Tooth Disease, a narrower term within Neuromuscular Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
77
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 23 studies in Charcot-Marie-Tooth Disease with a site in France — 6 open to participants now, 10 under way, 2 of them phase 3. Charcot-Marie-Tooth Disease · France.

Started
2021
with 2 others
Observational
6 of 23
3 open now
Registered
11th of 23
by date
Lead sponsor
2 of 23
Assistance Publique - Hôpitaux de Paris

Among the 23 studies in Charcot-Marie-Tooth Disease with a site in France, this one is one of 3 that started in 2021, is one of 6 observational ones, and was the 11th registered.

Charcot-Marie-Tooth Disease

113 studies on the registry are indexed under Charcot-Marie-Tooth Disease; 38 are open to participants now.

This study's enrollment of 77 is below the median of 120 across 47 observational studies indexed under Charcot-Marie-Tooth Disease.

Browse Charcot-Marie-Tooth Disease studies →

Open to participants now

6 of the 23 studies in Charcot-Marie-Tooth Disease with a site in France are open now, in 1 country. Each count lists the studies.

All 6 open studies →

Who these studies take

Of the 32 Charcot-Marie-Tooth Disease studies recruiting now, 14 (44%) set no upper age limit and 14 (44%) stop at 75 or younger; 14 take children under 18; 13 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 23 studies in Charcot-Marie-Tooth Disease with a site in France, or all of them as a file.
02

Study summary

The instrumental evaluation of standing postural control by posturographic analysis supplements the clinical evaluation and, as such, is recommended by the French National Authority for Health (HAS 2007). The quantitative data obtained after a standardized postural examination appear relevant for the longitudinal follow-up of neuromuscular patients and hemiparetic patients. Neuro muscular (NM) diseases are progressive, these instrumental evaluations can highlight a deterioration or stabilization of postural control possibly not observable with the scores on clinical scales.

The K-Force Plates, recently developed appear to be an interesting alternative to the stabilometry platforms currently used. Static and dynamic conditions in upright position are tested. Moreover, posturologic, kinematics data and clinical scores are correlated to increase understanding of strategies during postural control tasks in patients with stroke and in patients with NM disorders.

Read the detailed description

To date, no clinical validation study of these K-Force Plates force platforms has been proposed. The investigator hypothesize that the data obtained by the Plates are comparable to the measurements made by the reference tool, the AMTI platforms during a static and dynamic posturographic examination in MNM, hemiparetic and healthy subjects. The strategies of the patients (stroke and NM) during the dynamic task are also explored with kinematic analysis in correlation with data from force platforms and clinical scores.

03

Conditions studied

  • Neuromuscular Diseases
  • Hemiparesis
  • Charcot-Marie-Tooth Disease

Browse trials for

Keywords

  • Neuromuscular Diseases
  • Charcot-Marie-Tooth Disease
  • Hemiparesis
04

In context

Charcot-Marie-Tooth Disease Reclassified

113 studies on the registry are indexed under Charcot-Marie-Tooth Disease; 38 are open to participants now.

This study's enrollment of 77 is below the median of 120 across 47 observational studies indexed under Charcot-Marie-Tooth Disease.

Browse Charcot-Marie-Tooth Disease studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Compared within Charcot-Marie-Tooth Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neuromuscular Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Single stroke hemiparetic patient, or patient with neuro-muscular disease, or healthy subject free of neurological disorder and other disease.

Eligibility criteria

"Eligible couples must present all the following criteria :

  • Signing of the form
  • Men and women aged from 18
  • Single stroke hemiparetic patient, or patient with neuro-muscular disease, or healthy subject free of neurological disorder and other disease
  • Patient able to stand alone at least 30 seconds without technical assistance (multiple repetitions)

To be included, patient should not present any of the following criteria :

  • Bilateral brain injury, cerebellar syndrome
  • Other disease or defect that may interfere with the study such as visual, vestibular or other related uncontrolled medical condition
  • Major cognitive impairment that does not allow evaluation
  • Pregnant women, breastfeeding
  • Non affiliated to a social security scheme"
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

06

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
77 participants (actual)
Patient registry
No

Groups and cohorts

  • Neuromuscular disease (MNM) subjects (Charcot Marie Tooth disease, CMT)

    Other: Posturological examination on KPlates and AMTI platforms · Other: Berg Balance Scale (BBS)

  • Hemiparetic subjects

    Other: Posturological examination on KPlates and AMTI platforms · Other: Berg Balance Scale (BBS)

  • Healthy subjects

    Other: Posturological examination on KPlates and AMTI platforms

Interventions

  • OtherPosturological examination on KPlates and AMTI platforms

    By an unique evaluator

  • OtherBerg Balance Scale (BBS)

    Falls and fera of falling, motor and sensory impairments

07

What researchers measure

Primary outcomes

  1. Evaluate the concurrent validity of K-Force Plates (K-Invent) force platforms in comparison with reference platforms (AMTI) for posturological examination in static and dynamic conditions of MNM subjects (CMT), hemiparetic subjects and healthy subjects.

    Intraclass correlation coefficient (ICC) of the mean velocity of the pressure center (CP) with the both platforms during the posturological examination. The average of 3 tests carried out will be taken

    Time frame: Day 0

Secondary outcomes

  1. Evaluate convergent validity with the reference scale for the assessment of equilibrium disorders

    Berg's equilibrium rating scale (0-56) ( score at 0: worse outcome)

    Time frame: Day 0

  2. Compare the posturology and kinematics between stroke and healthy subjects and between NM and healthy subjects

    Explore the relations between the posturology, kinematics and clinical parameters in stroke population and in NM population.

    Time frame: Day 0

08

Study locations

1 site
  • Laboratoire d'analyse du mouvement, Hopital Raymond Poincaré, APHP
    Garches, 92380, France
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2021 to primary completion in Feb 2024, 34 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 20, 2020
First posted
Feb 25, 2020
StartActual
Apr 1, 2021
Primary completionActual
Feb 9, 2024
CompletionActual
Feb 9, 2024
Last update
Jun 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04283175
Collaborators
Motion analysis laboratory, Garches, Fondation de Garches
Responsible party
Sponsor
First posted
Feb 25, 2020
Start date
Apr 1, 2021
Primary completion
Feb 9, 2024
Completion
Feb 9, 2024
Last update
Jun 4, 2025

Study contacts

Celine Bonnyaud, PhD
principal investigator · Laboratoire d'analyse du mouvement, Hopital Raymond Poincaré, APHP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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