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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT04283175

Collaborator

Motion analysis laboratory, Garches (Other), Fondation de Garches (Other)

Enrollment

Location

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuromuscular Diseases Hemiparesis Charcot-Marie-Tooth Disease	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 Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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
Healthy subjects	Other: Posturological examination on KPlates and AMTI platforms By an unique evaluator

Arm

Intervention/Treatment

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

Healthy subjects

Other: Posturological examination on KPlates and AMTI platforms

By an unique evaluator

Outcome Measures

Primary Outcome Measures

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. [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 Outcome Measures

Evaluate convergent validity with the reference scale for the assessment of equilibrium disorders [Day 0]
Berg's equilibrium rating scale (0-56) ( score at 0: worse outcome)
Compare the posturology and kinematics between stroke and healthy subjects and between NM and healthy subjects [Day 0]
Explore the relations between the posturology, kinematics and clinical parameters in stroke population and in NM population.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

"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"