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

NCT ID: NCT04283175

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2024-02-09

Brief Summary

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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

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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.

Conditions

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Neuromuscular Diseases Hemiparesis Charcot-Marie-Tooth Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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

Posturological examination on KPlates and AMTI platforms

Intervention Type OTHER

By an unique evaluator

Berg Balance Scale (BBS)

Intervention Type OTHER

Falls and fera of falling, motor and sensory impairments

Hemiparetic subjects

Posturological examination on KPlates and AMTI platforms

Intervention Type OTHER

By an unique evaluator

Berg Balance Scale (BBS)

Intervention Type OTHER

Falls and fera of falling, motor and sensory impairments

Healthy subjects

Posturological examination on KPlates and AMTI platforms

Intervention Type OTHER

By an unique evaluator

Interventions

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Posturological examination on KPlates and AMTI platforms

By an unique evaluator

Intervention Type OTHER

Berg Balance Scale (BBS)

Falls and fera of falling, motor and sensory impairments

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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"
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Motion analysis laboratory, Garches

UNKNOWN

Sponsor Role collaborator

Fondation de Garches

UNKNOWN

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Celine Bonnyaud, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Garches, , France

Site Status

Countries

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France

Other Identifiers

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2019-A02392-55

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP19974

Identifier Type: -

Identifier Source: org_study_id

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