Immersive Virtual Reality in Functional Motor Disorders

Study Overview
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Brief Summary
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The study aims to demonstrate the effectiveness and superiority of a 5-day immersive VR-rehabilitation treatment versus a 5-day conventional rehabilitation treatment in reducing FMDs symptoms severity, assessed by the Simplified Functional Movement Disorders Rating Scale (S- FMDRS).

Detailed Description
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This is a single-blind, randomized controlled trial to evaluate the superiority of immersive VR distractors combined with graded physical exercises over conventional rehabilitation (without any VR distractors) to reduce FMDs symptoms and improve gait and balance. Patients will be randomized to receive the experimental training (VRG) or the control training (CRG) (allocation ratio 1:1). The primary and secondary outcomes will be measured by the same examiner before (T0), at the end of the treatment (T1), and at three-month follow-up after the end of the treatment (T2). The test order will be the same across all evaluation sessions. The examiner will be blinded to group assignments.

Official Title
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Effectiveness of Immersive Virtual Reality Rehabilitation Program to Reduce Symptoms Severity and Improve Quality of Life in Patients With Functional Motor Disorders

Conditions
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Functional Motor Disorders

Intervention / Treatment
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* Device: Virtual Reality intervention
* Behavioral: Control Group intervention


Participation Criteria
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Eligibility Criteria
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Inclusion criteria were: established diagnosis of FMDs, age ≥ 18 years, and acceptance of the diagnosis. Exclusion criteria were: prominent dissociative seizures, prominent cognitive and/or physical impairment that precluded signing the informed consent form for study participation based on clinical judgment, incomplete assessment, and questionnaire because of language comprehension difficulties.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Group<br>Patients will attend the in-person 5-day rehabilitation program (2 h/day) to re-establish normal movement patterns in a dynamic and challenging VR environment. During each session, the patients will be supervised by the physiotherapist. The immersive VR system will simultaneously deliver visual and auditory distractors during the exercises. | Device: Virtual Reality intervention<br>* Virtual reality (VR) is a powerful tool to create an illusory state in which the user can feel that they have been transported to a new location (place illusion), that events happening are real (plausibility illusion), and even that bodies have been substituted by an avatar (embodiment illusion). VR illusions are driven by the same neurological mechanisms of everyday perception of the body in the world and induce realistic responses to VR.<br>|
| Active Comparator: Control Group Treatment<br>Patients will attend the in-person 5-day rehabilitation program (2 h/day) to re-establish normal movement patterns within a multidisciplinary etiological framework according to a validated rehabilitation protocol for FMDs.The conventional group will undergo the same dose, frequency, and intensity of rehabilitation treatment as the VR group consisting of rehabilitation without VR exercises. | Behavioral: Control Group intervention<br>* Treatment will follow general treatment principles in physiotherapy for FMDs: (1) education; (2) exploration of how symptoms affect movement and posture; (3) retraining movement using strategies based on redirection of attention; and (4) development of a self-management plan.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score | Objective-rated validated scale to rate the duration and severity of functional motor symptoms (range: 0-54; higher = worse). | Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Multidimensional Fatigue Inventory Scale (MFI-20) score | It evaluates fatigue differentiating general, physical, reduced-activity, reduced-motivation, and mental fatigue (subscale range: 4-20; higher = worse). | Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2). | 
| Change in the Brief Pain Inventory (BPI) score | It evaluates pain intensity (range: 0-40; higher = worse) and interference (range: 0-70; higher = worse). | Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2). | 
| Change in the Beck Depression Inventory (BDI-II) score | It evaluates depression (range: 0-63; higher = worse). | Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2). | 
| Change in the Beck Anxiety Inventory (BAI) score | It evaluates anxiety (range: 0-63; higher = worse). | Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2). | 
| Change in the 12-item Short-Form Health Survey (SF-12) score | The health-Related QoL will be evaluated by the Mental Health and Physical functioning of the 12-item Short-Form Health Survey (SF-12) (range: 0-100; higher = better) | Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2). | 
| Change in the Clinical Global Impression (CGI) score | Self-rated perception of change will be assessed with the 7-point Clinical Global Impression (CGI) scale with scores from 1 (very much improved) to 7 (very much worse). | Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2). | 
| Change in gait speed (cm/sec) | Gait analysis will be used to collect gait speed (cm/s). | Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2). | 
| Change in Swing time (%) | Gait analysis will be used to collect swing time (%). | Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2). | 
| Change in Stride time (s) | Gait analysis will be used to collect stride time (s). | Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2). | 
| Change in Stride length (cm) | Gait analysis will be used to collect stride length (cm). | Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2). | 
| Change in sway area (mm2) | An electronic monaxial stabilometric platform will be used to collect sway area (mm2). | Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2). | 
| Change in total excursion path (mm) | An electronic monaxial stabilometric platform will be used to collect total excursion path (mm). | Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2). | 
| Change in velocity of Cop displacement in the anteroposterior directions (mm/s) | An electronic monaxial stabilometric platform will be used to collect the velocity of Cop displacement in the anteroposterior directions. | Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2). | 
| Change in velocity of Cop displacement in the mediolateral directions (mm/s) | An electronic monaxial stabilometric platform will be used to collect the velocity of Cop displacement in the mediolateral directions. | Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2). | 
| Change in the Toronto Alexithymia Scale (TAS-20) score | It evaluates the level of alexithymia (range: 20-100; higher = worse) | Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality