ClinicalTrials.gg
Not yet recruitingNCT06884735TERV-SDPMUpdated Feb 25, 2026

Virtual Reality Exposure Therapy (VRET) in Psychomotor Disadaptation Syndrome

An interventional study of exposure to virtual reality in Psychomotor Disadaptation Syndrome, sponsored by Hopital Nord Franche-Comte. Not yet recruiting at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-02-25.

Sponsored by Hopital Nord Franche-Comte · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Psychomotor Disadaptation Syndrome

Keywords

  • Virtual Reality Exposure Therapy
03

In context

Lead sponsor

Hopital Nord Franche-Comte is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • (MMSE) score ≥ 20

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    exposure to a previous vacuum

    exposure to a previous vacuum

    Other: exposure to virtual reality

  • Sham comparator
    museum exposure

    museum exposure

    Other: exposure to virtual reality

Interventions

  • Otherexposure to virtual reality

    exposure to virtual reality

06

What researchers measure

Primary outcomes

  1. Balance

    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

    Time frame: Day 1

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06884735
Lead sponsor
Hopital Nord Franche-Comte
Responsible party
Sponsor
First posted
Mar 19, 2025
Start date
Apr 1, 2026 (estimated)
Primary completion
Apr 1, 2029 (estimated)
Completion
Apr 1, 2029 (estimated)
Last update
Feb 25, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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