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Completed

NCT Number: NCT04283175

Validation Study of Posturology Platforms 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.

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Key information

Conditions

Neuromuscular Diseases Charcot-Marie-Tooth Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hemiparesis Hereditary Sensory and Motor Neuropathy Heredodegenerative Disorders, Nervous System Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Laboratoire d'analyse du mouvement, Hopital Raymond Poincaré, APHP

Garches, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

"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"

Treatment and study plan

Posturological examination on KPlates and AMTI platforms

Other

By an unique evaluator

Berg Balance Scale (BBS)

Other

Falls and fera of falling, motor and sensory impairments

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.

    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

Secondary outcomes

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

    Time frame: Day 0

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

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

    Time frame: Day 0

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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Fondation de Garches
  • Motion analysis laboratory, Garches

Registry information

Official study title

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

Acronym: KPLATES

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 25, 2020
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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