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Clinical Trials/NCT06884735
NCT06884735Not yet recruitingNot Applicable

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

Hopital Nord Franche-Comte1 site in 1 country24 target enrollmentStarted: April 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
24
Locations
1
Primary Endpoint
Balance

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

exposure to a previous vacuum

Experimental

exposure to a previous vacuum

Intervention: exposure to virtual reality (Other)

museum exposure

Sham Comparator

museum exposure

Intervention: exposure to virtual reality (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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