Virtual Reality Exposure Therapy (VRET) in Psychomotor Disadaptation Syndrome

Not Applicable

Not yet recruiting

• Conditions: Psychomotor Disadaptation Syndrome

• Registration Number: NCT06884735
• Lead Sponsor: Hopital Nord 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19
• Study Start: 2025-09-01
• Primary Completion: 2028-09-03
• Study Completion: 2028-09-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Balance	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

Trial Locations

Locations (1)

Hôpital Nord Franche-Comté; 🇫🇷 Trevenans, France