Posture Standards of a New Dynamic Platform (VESTINORM)

Determination of Standards on a New Static and Dynamic Posture Platform

The objective is the determination of norms on healthy subjects, by age groups (20-29/30-39/40-49/50-59/60-69/70-79/80-89 years) for the posturological evaluation of four posture tests: the sensory organization test, the motor coordination test, the adaptation test, the stability limit test.

Study Overview

• Status: Recruiting
• Conditions: Static and Dynamic Posture Standards
• Intervention / Treatment: Other: Posture standards

Detailed Description

The objective is the determination of norms by age groups (20-29/30-39/40-49/50-59/60-69/70-79/80-89) of four tests of posture: the test of sensory organization, the test of motor coordination, the test of adaptation, the test of stability limit, of a new platform of static and dynamic posturology.

When moving within an environment, sensory information from the environment and the body is registered within the sensory systems (Hilber et al., 2018). More specifically, it is the functions of balancing and spatial orientation that are brought into play to produce behavioral responses that are adapted to different situations and to anticipate events in one's environment. It is therefore essential to establish not only posturological norms but also norms for the function of spatial orientation in order to propose a complete assessment of the postural and spatial cognitive profile of healthy subjects that can serve as a reference population.

These standards will serve as a basis for determining the pathological values during the exploration of numerous pathologies, in particular vestibular pathology, pathologies inducing balance and posture disorders (neurology, rheumatology).

The measurement of posture and variations of the center of gravity represents an important output marker, little or never taken into account in medical practice, and linked to a large number of integration processes, in particular multisensory and sensory-motor. Its parameters vary according to the sensory information received and processed related to the maintenance of balance: visual system, vestibular system, somesthesic system, visceral sensory system. Posture is also modulated by the attentional level and cognitive load. Posturography is one of the most cost-effective instruments in terms of clinical utility, particularly in the diagnosis of vestibular pathology (Stewart et al., 1999). Thus, the development of such an instrument represents an innovative and advantageous development in terms of diagnostic improvement.

the investigators will perform the standard setting according to a precise statistical approach (analysis of variance ANOVA with correlation coefficients and 95% confidence intervals to establish test-retest reliability).

• Study Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • Recruiting
    • Caen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• No symptoms of vertigo, dizziness, balance disorders, motion sickness;
• No history of neurological or musculoskeletal pathology;
• No history of neurological or musculoskeletal pathology; -No known medication or medication likely to modify balance;
• No history of two or more falls in the six months preceding the study;
• No psychiatric disorder;
• Normal vision with or without correction;
• Be able to stand for more than 20 minutes and walk independently

Exclusion Criteria:

• Subjects under 20 years of age
• Pregnant or breastfeeding women,
• Persons in an emergency situation or unable to give their consent, including adults under guardianship
• Persons under legal protection
• Persons deprived of liberty, minors, protected adults,
• Inclusion of the subject in another interventional research protocol with pharmacological objectives during the present study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: postural group; one healthy group of different age	Other: Posture standards; Dynamic and static Postural measurements according to four types of tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory Organization Test (SOT)	Standards (arbitrary unit)	day 1 after inclusion
Sensory Organization Test (SOT)	Standards (arbitrary unit)	day 15 after inclusion
Motor Coordination Test (MCT)	Standards (arbitrary unit)	day 1 after inclusion
Motor Coordination Test (MCT)	Standards (arbitrary unit)	day 15 after inclusion
Adaptation Test (ADT)	Standards (arbitrary unit)	day 1 after inclusion
Adaptation Test (ADT)	Standards (arbitrary unit)	day 15 after inclusion
Limits of Stability Test (LOS)	Standards (arbitrary unit)	day 1 after inclusion
Limits of Stability Test (LOS)	Standards (arbitrary unit)	day 15 after inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 3, 2022
• Primary Completion (ANTICIPATED): May 31, 2025
• Study Completion (ANTICIPATED): June 30, 2025

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: September 5, 2022
• First Posted (ACTUAL): September 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 5, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: vertigo; algorithm; diagnostic; balance; posture; physiotherapist; standards; platform
• Other Study ID Numbers: 2022-A00856-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No