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

NCT04283175 | Completed

• 2 other identifiers: APHP199742019-A02392-55
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Diseases; Hemiparesis; Charcot-Marie-Tooth Disease

Keywords

Neuromuscular Diseases; Charcot-Marie-Tooth Disease; Hemiparesis

Outcome Measures

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.

  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 Outcomes (2)

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

  Day 0

• Compare the posturology and kinematics between stroke and healthy subjects and between NM and healthy subjects

  Day 0

Study Arms (3)

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

Interventions

Posturological examination on KPlates and AMTI platforms OTHER

By an unique evaluator

Healthy subjects; Hemiparetic subjects; Neuromuscular disease (MNM) subjects (Charcot Marie Tooth disease, CMT)

Berg Balance Scale (BBS) OTHER

Falls and fera of falling, motor and sensory impairments

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

"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"

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Motion analysis laboratory, Garches: collaborator
• Fondation de Garches: collaborator

Study Sites (1)

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

Garches, 92380, France

Location

MeSH Terms

Conditions

Neuromuscular Diseases; Paresis; Charcot-Marie-Tooth Disease

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Celine Bonnyaud, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 25, 2020
• Study Start: April 1, 2021
• Primary Completion: February 9, 2024
• Study Completion: February 9, 2024
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

FR (1)