Virtual Reality Exposure Therapy (VRET) in Psychomotor Disadaptation Syndrome

NCT ID: NCT06884735

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-09-03

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.

Conditions

Psychomotor Disadaptation Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

exposure to a previous vacuum

exposure to a previous vacuum

Group Type: EXPERIMENTAL

exposure to virtual reality

Intervention Type: OTHER

exposure to virtual reality

museum exposure

museum exposure

Group Type: SHAM_COMPARATOR

exposure to virtual reality

Intervention Type: OTHER

exposure to virtual reality

Interventions

exposure to virtual reality

exposure to virtual reality

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Nord Franche-Comte

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Nord Franche-Comté

Trévenans, , France

Countries

France

Facility Contacts

Elodie Bouvier

Role: primary

elodie.bouvier@hnfc.fr

+33384983570

Other Identifiers

2024-03-TERV-SDPM

Identifier Type: -

Identifier Source: org_study_id