Virtual Reality Exposure Therapy (VRET) in Psychomotor Disadaptation Syndrome

NCT06884735 | Not Yet Recruiting

• 1 other identifier: 2024-03-TERV-SDPM
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Virtual Reality Exposure Therapy

Outcome Measures

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

  Day 1

Study Arms (2)

exposure to a previous vacuum

EXPERIMENTAL

exposure to a previous vacuum

Other: exposure to virtual reality

museum exposure

SHAM COMPARATOR

museum exposure

Other: exposure to virtual reality

Interventions

exposure to virtual reality OTHER

exposure to virtual reality

exposure to a previous vacuum; museum exposure

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Nord Franche-Comte: lead

Study Sites (1)

Hôpital Nord Franche-Comté

Trévenans, 90400, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 19, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)