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Virtual Reality Exposure Therapy (VRET) in Psychomotor Disadaptation Syndrome (TERV-SDPM)

H

Hopital Nord Franche-Comte

Status

Not yet enrolling

Conditions

Psychomotor Disadaptation Syndrome

Treatments

Other: exposure to virtual reality

Study type

Interventional

Funder types

Other

Identifiers

NCT06884735
2024-03-TERV-SDPM

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

exposure to a previous vacuum
Experimental group
Description:
exposure to a previous vacuum
Treatment:
Other: exposure to virtual reality
museum exposure
Sham Comparator group
Description:
museum exposure
Treatment:
Other: exposure to virtual reality

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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