Immersive Virtual Reality in Functional Motor Disorders
- Conditions
- Functional Motor Disorders
- Interventions
- Device: Virtual Reality interventionBehavioral: Control Group intervention
- Registration Number
- NCT05581134
- Lead Sponsor
- Marialuisa Gandolfi
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual Reality Group Virtual Reality intervention 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. Control Group Treatment Control Group intervention 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.
- Primary Outcome Measures
Name Time Method Change in the Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2). Objective-rated validated scale to rate the duration and severity of functional motor symptoms (range: 0-54; higher = worse).
- Secondary Outcome Measures
Name Time Method Change in the Multidimensional Fatigue Inventory Scale (MFI-20) score Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2). It evaluates fatigue differentiating general, physical, reduced-activity, reduced-motivation, and mental fatigue (subscale range: 4-20; higher = worse).
Change in the Beck Depression Inventory (BDI-II) score Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2). It evaluates depression (range: 0-63; higher = worse).
Change in the Clinical Global Impression (CGI) score Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2). 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).
Change in Swing time (%) Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2). Gait analysis will be used to collect swing time (%).
Change in Stride length (cm) Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2). Gait analysis will be used to collect stride length (cm).
Change in sway area (mm2) Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2). An electronic monaxial stabilometric platform will be used to collect sway area (mm2).
Change in the Brief Pain Inventory (BPI) score Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2). It evaluates pain intensity (range: 0-40; higher = worse) and interference (range: 0-70; higher = worse).
Change in gait speed (cm/sec) Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2). Gait analysis will be used to collect gait speed (cm/s).
Change in 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). An electronic monaxial stabilometric platform will be used to collect total excursion path (mm).
Change in the Beck Anxiety Inventory (BAI) score Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2). It evaluates anxiety (range: 0-63; higher = worse).
Change in the 12-item Short-Form Health Survey (SF-12) score Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2). 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)
Change in velocity of Cop displacement in the anteroposterior directions (mm/s) Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2). An electronic monaxial stabilometric platform will be used to collect the velocity of Cop displacement in the anteroposterior directions.
Change in Stride time (s) Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2). Gait analysis will be used to collect stride time (s).
Change in velocity of Cop displacement in the mediolateral directions (mm/s) Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2). An electronic monaxial stabilometric platform will be used to collect the velocity of Cop displacement in the mediolateral directions.
Change in the Toronto Alexithymia Scale (TAS-20) score Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2). It evaluates the level of alexithymia (range: 20-100; higher = worse)
Trial Locations
- Locations (1)
Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona
🇮🇹Verona, Italy