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临床试验/NCT06884735
NCT06884735尚未招募不适用

Virtual Reality Exposure Therapy (VRET) for Balance in Patients Suffering From Psychomotor Disadaptation Syndrome

Hopital Nord Franche-Comte1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
试验地点
1
主要终点
Balance

研究概览

简要总结

According to demographic projections, by 2040, a quarter of the French population will be over 65. In this age group, the quality and quantity of visual, somaesthetic and vestibular information decline. This weakening of the balancing and the recurrence of falls lead to a restriction of activities of daily living and give rise to a fear of falling.

Psychomotor maladjustment syndrome (PMDS) is a serious consequence of falls. A significant retropulsion when sitting or standing, as well as hypertonia characterize the posturobehavioral component of PMDS. It coexists with a psychological component, marked by a fear of the anterior emptiness. A series of studies inducing fear and experimentally manipulating its intensity demonstrated a greater displacement of the center of pressure when subjects were exposed to elevated platforms. In addition to the subjective evaluation of fear, this emotion can be assessed by heart rate variability.

Despite the existence of standards and metrics adapted to the clinical setting, only one study investigated the association between the number of falls and heart rate variability in patients with neurodegenerative disorders. In recent years, cognitive and behavioral therapies using virtual reality (TERV) have improved balance in patients with cardiovascular disease and Parkinson's disease. Virtual reality (VR) thus appears to be an interesting therapeutic approach to the treatment of psychological as well as postural-behavioral disorders of PDMS. Although the feasibility of a VR intervention has been tested in elderly people (APs) suffering from PMDS, its effect has never been evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients diagnosed with PMDS
  • •Ability to stand without human or technical assistance
  • •Falls Efficacy Scale International Short (FES-I short) > 13
  • •Functional Reach Test (FRT) score < 26 cm
  • •Mini-Mental State Examination (MMSE) score ≥ 20

排除标准

  • •Patients with disorders that may interfere with immersion in virtual reality (e.g. cerebellar syndromes, Parkinsonian syndromes, hallucinations, sensory or neurocognitive disorders)
  • •Cybermalaise or cyberkinetosis

研究组 & 干预措施

exposure to a previous vacuum

Experimental

exposure to a previous vacuum

干预措施: exposure to virtual reality (Other)

museum exposure

Sham Comparator

museum exposure

干预措施: exposure to virtual reality (Other)

结局指标

主要结局

Balance

时间窗: Day 1

Average velocity variance of the center of pressure (cm/s) measured by a stabilometric measurement platform before, immediately after, then post-24h exposure to VR

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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