Neuromuscular DiseasesKPLATESNCT04283175
Validation Study of Posturology Platforms for Evaluating Postural Control of Hemiparetic and Neuro-muscular Patients
An observational study of Neuromuscular Diseases and Hemiparesis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Diseases, Hemiparesis, Charcot-Marie-Tooth Disease
- What is being tested?
- Posturological examination on KPlates and AMTI platforms and Berg Balance Scale (BBS)
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2021to 9 Feb 2024
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Single stroke hemiparetic patient, or patient with neuro-muscular disease, or healthy subject free of neurological disorder and other disease.
"Eligible couples must present all the following criteria :
- Signing of the informed consent 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"
Trial locations and contacts
1 site in 1 country.
France1 site
Laboratoire d'analyse du mouvement, Hopital Raymond Poincaré, APHP
Garches, 92380
About this study
Official title: Validation Study of Posturology Platforms and Exploratory Study for Evaluating Postural Control of Hemiparetic and Neuro-muscular Patients
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.
- Being tested
- Posturological examination on KPlates and AMTI platforms, Berg Balance Scale (BBS)
- Keywords
- Neuromuscular Diseases, Charcot-Marie-Tooth Disease, Hemiparesis
- Medical subject headings
- Neuromuscular Diseases, Paresis, Charcot-Marie-Tooth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posturological examination on KPlates and AMTI platformsOther
By an unique evaluator
Berg Balance Scale (BBS)Other
Falls and fera of falling, motor and sensory impairments
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular disease (MNM) subjects (Charcot Marie Tooth disease, CMT) | Not described Receives: Other: Posturological examination on KPlates and AMTI platforms; Other: Berg Balance Scale (BBS) | |
| Hemiparetic subjects | Not described Receives: Other: Posturological examination on KPlates and AMTI platforms; Other: Berg Balance Scale (BBS) | |
| Healthy subjects | Not described Receives: Other: Posturological examination on KPlates and AMTI platforms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
Secondary outcomes (2)
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)
Measured: Day 0
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.
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 posted25 Feb 2020
- Study start1 Apr 2021
- Primary completion9 Feb 2024
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Motion analysis laboratory, Garches, Fondation de Garches
- Responsible party
- Sponsor
- Investigators
- Celine Bonnyaud, PhD, Principal investigator, Laboratoire d'analyse du mouvement, Hopital Raymond Poincaré, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283175
- Sponsor's protocol ID
- APHP19974
- Other IDs
- 2019-A02392-55
- Acronym
- KPLATES
- Status last verified
- May 2025
- First submitted
- 20 Feb 2020
- Last updated
- 4 Jun 2025
- 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 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of Posturology Platforms and Exploratory Study for Evaluating Postural Control of Hemiparetic and Neuro-muscular Patients
- ClinicalTrials.gov ID
- NCT04283175
- Acronym / sponsor ID
- KPLATES / APHP19974
- Keywords
- Neuromuscular Diseases, Charcot-Marie-Tooth Disease, Hemiparesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Motion analysis laboratory, Garches, Fondation de Garches
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 25 Feb 2020 (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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Single stroke hemiparetic patient, or patient with neuro-muscular disease, or healthy subject free of neurological disorder and other disease.
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 |
|---|---|---|
| Posturological examination on KPlates and AMTI platformsBy an unique evaluator | Other | Healthy subjects, Hemiparetic subjects, Neuromuscular disease (MNM) subjects (Charcot Marie Tooth disease, CMT) |
| Berg Balance Scale (BBS)Falls and fera of falling, motor and sensory impairments | Other | Hemiparetic subjects, Neuromuscular disease (MNM) subjects (Charcot Marie Tooth disease, CMT) |
Primary outcome
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.
Time frame: Day 0
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
2 secondary outcomes
Evaluate convergent validity with the reference scale for the assessment of equilibrium disorders
Time frame: Day 0
Compare the posturology and kinematics between stroke and healthy subjects and between NM and healthy subjects
Time frame: Day 0
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 4 Jun 2025.
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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.
Celine Bonnyaud, PhD principal investigator
Laboratoire d'analyse du mouvement, Hopital Raymond Poincaré, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Diseases and Hemiparesis, run by Assistance Publique - Hôpitaux de Paris 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?
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 4 Jun 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?
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. (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 4 Jun 2025.