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

Hemiparesis Clinical Trial

— KPLATES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04283175
• Other study ID #: APHP19974
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: August 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Celine Bonnyaud, PhD
• Phone: +331 71 14 49 21
• Email: celine.bonnyaud[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

"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"

Related Conditions & MeSH terms

• Charcot-Marie-Tooth Disease
• Hemiparesis
• Hereditary Sensory and Motor Neuropathy
• Nerve Compression Syndromes
• Neuromuscular Diseases
• Paresis
• Tooth Diseases

Intervention

Other:
• Posturological examination on KPlates and AMTI platforms
By an unique evaluator
• Berg Balance Scale (BBS)
Falls and fera of falling, motor and sensory impairments

Locations

Country	Name	City	State
France	Laboratoire d'analyse du mouvement, Hopital Raymond Poincaré, APHP	Garches

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Fondation de Garches, Motion analysis laboratory, Garches

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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