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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04283175
Acronym
KPLATES
Enrollment
77
Registered
2020-02-25
Start date
2021-04-01
Completion date
2024-02-09
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Diseases, Hemiparesis, Charcot-Marie-Tooth Disease

Keywords

Neuromuscular Diseases, Charcot-Marie-Tooth Disease, Hemiparesis

Brief 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.

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.

Interventions

OTHERPosturological examination on KPlates and AMTI platforms

By an unique evaluator

Falls and fera of falling, motor and sensory impairments

Sponsors

Motion analysis laboratory, Garches
CollaboratorUNKNOWN
Fondation de Garches
CollaboratorUNKNOWN
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
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.Day 0Intraclass 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

Secondary

MeasureTime frameDescription
Evaluate convergent validity with the reference scale for the assessment of equilibrium disordersDay 0Berg's equilibrium rating scale (0-56) ( score at 0: worse outcome)
Compare the posturology and kinematics between stroke and healthy subjects and between NM and healthy subjectsDay 0Explore the relations between the posturology, kinematics and clinical parameters in stroke population and in NM population.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026