Thinking of joining a study?

Register your interest

NCT06884735 | NOT YET RECRUITING | Psychomotor Disadaptation Syndrome


Virtual Reality Exposure Therapy (VRET) in Psychomotor Disadaptation Syndrome
Sponsor:

Northern Hospital Franche-Comte

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.

Condition or disease

Psychomotor Disadaptation Syndrome

Intervention/treatment

exposure to virtual reality

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 24 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : Virtual Reality Exposure Therapy (VRET) for Balance in Patients Suffering from Psychomotor Disadaptation Syndrome
Actual Study Start Date : 2025-09-01
Estimated Primary Completion Date : 2028-09-03
Estimated Study Completion Date : 2028-09-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

Virtual Reality Exposure Therapy (VRET) in Psychomotor Disadaptation Syndrome

Location Details

NCT06884735


Please Choose a site



How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

France,

North Franche-Comté Hospital

Trevenans, France, 90400

Loading...