跳至主要内容
临床试验/NCT05532176
NCT05532176进行中(未招募)不适用

Determination of Standards on a New Static and Dynamic Posture Platform

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2023年6月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
260
试验地点
1
主要终点
Sensory Organization Test (SOT)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

postural group

Other

one healthy group of different age

干预措施: Posture standards (Other)

结局指标

主要结局

Sensory Organization Test (SOT)

时间窗: day 15 after inclusion

Standards (arbitrary unit)

Adaptation Test (ADT)

时间窗: day 15 after inclusion

Standards (arbitrary unit)

Motor Coordination Test (MCT)

时间窗: day 15 after inclusion

Standards (arbitrary unit)

Limits of Stability Test (LOS)

时间窗: day 15 after inclusion

Standards (arbitrary unit)

Sensory Organization Test (SOT)

时间窗: day 1 after inclusion

Standards (arbitrary unit)

Motor Coordination Test (MCT)

时间窗: day 1 after inclusion

Standards (arbitrary unit)

Adaptation Test (ADT)

时间窗: day 1 after inclusion

Standards (arbitrary unit)

Limits of Stability Test (LOS)

时间窗: day 1 after inclusion

Standards (arbitrary unit)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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