Immersive Virtual Reality in Functional Motor Disorders

Not Applicable

Recruiting

• Conditions: Functional Motor Disorders

• 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.

Study Timeline

• Study Start: 2022-09-29
• Status Verified: 2022-10
• Study First Submitted: 2022-10-01
• Study First Submitted QC: 2022-10-11
• Last Update Submitted: 2022-10-11
• Study First Posted: 2022-10-14
• Last Update Posted: 2022-10-14
• Primary Completion: 2023-08-30
• Study Completion: 2023-09-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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