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

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.

Study Overview

• Status: Completed
• Conditions: Neuromuscular Diseases; Charcot-Marie-Tooth Disease; Hemiparesis
• Intervention / Treatment: Other: Posturological examination on KPlates and AMTI platforms; Other: Berg Balance Scale (BBS)

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 Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

"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"

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy subjects	Other: Posturological examination on KPlates and AMTI platforms; By an unique evaluator
Neuromuscular disease (MNM) subjects (Charcot Marie Tooth disease, CMT)	Other: Posturological examination on KPlates and AMTI platforms; By an unique evaluator; Other: Berg Balance Scale (BBS); Falls and fera of falling, motor and sensory impairments
Hemiparetic subjects	Other: Posturological examination on KPlates and AMTI platforms; By an unique evaluator; Other: Berg Balance Scale (BBS); Falls and fera of falling, motor and sensory impairments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	Day 0

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Motion analysis laboratory, Garches; Fondation de Garches
• Investigators: Principal Investigator: Celine Bonnyaud, PhD, Laboratoire d'analyse du mouvement, Hopital Raymond Poincaré, APHP

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): February 9, 2024
• Study Completion (Actual): February 9, 2024

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 30, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Neuromuscular Diseases; Hemiparesis; Charcot-Marie-Tooth Disease
• Additional Relevant MeSH Terms: Neurologic Manifestations; Stomatognathic Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Peripheral Nervous System Diseases; Neurodegenerative Diseases; Congenital Abnormalities; Heredodegenerative Disorders, Nervous System; Nervous System Malformations; Polyneuropathies; Paresis; Tooth Diseases; Charcot-Marie-Tooth Disease; Nerve Compression Syndromes; Hereditary Sensory and Motor Neuropathy; Neuromuscular Diseases
• Other Study ID Numbers: APHP19974; 2019-A02392-55 (Registry Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No