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NCT Number: NCT06884735

Virtual Reality Exposure Therapy (VRET) in Psychomotor Disadaptation Syndrome

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

exposure to virtual reality

Other

exposure to virtual reality

Primary outcomes

  1. Balance

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hopital Nord Franche-Comte

Other

Registry information

Official study title

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

Acronym: TERV-SDPM

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 19, 2025
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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