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

Recruiting

• Conditions: Neuromuscular Diseases; Hemiparesis; Charcot-Marie-Tooth Disease
• Interventions: Other: Posturological examination on KPlates and AMTI platforms; Other: Berg Balance Scale (BBS)

• Registration Number: NCT04283175
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

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 Timeline

• Study First Submitted: 2020-02-20
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-25
• Study Start: 2021-04-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-08-31
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neuromuscular disease (MNM) subjects (Charcot Marie Tooth disease, CMT)	Posturological examination on KPlates and AMTI platforms	-
Healthy subjects	Posturological examination on KPlates and AMTI platforms	-
Hemiparetic subjects	Berg Balance Scale (BBS)	-
Neuromuscular disease (MNM) subjects (Charcot Marie Tooth disease, CMT)	Berg Balance Scale (BBS)	-
Hemiparetic subjects	Posturological examination on KPlates and AMTI platforms	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Laboratoire d'analyse du mouvement, Hopital Raymond Poincaré, APHP; 🇫🇷 Garches, France