Clinical trial NCT05581134: Immersive Virtual Reality in Functional Motor Disorders
Official title: Effectiveness of Immersive Virtual Reality Rehabilitation Program to Reduce Symptoms Severity and Improve Quality of Life in Patients With Functional Motor Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Motor Disorders
Keywords: Virtual Reality
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score
timeFrame: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
Secondary outcomes:
measure: Change in the Multidimensional Fatigue Inventory Scale (MFI-20) score
timeFrame: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
measure: Change in the Brief Pain Inventory (BPI) score
timeFrame: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
measure: Change in the Beck Depression Inventory (BDI-II) score
timeFrame: Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).
measure: Change in the Beck Anxiety Inventory (BAI) score
timeFrame: Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).
measure: Change in the 12-item Short-Form Health Survey (SF-12) score
timeFrame: Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).
measure: Change in the Clinical Global Impression (CGI) score
timeFrame: Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).
measure: Change in gait speed (cm/sec)
timeFrame: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
measure: Change in Swing time (%)
timeFrame: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
measure: Change in Stride time (s)
timeFrame: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
measure: Change in Stride length (cm)
timeFrame: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
measure: Change in sway area (mm2)
timeFrame: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
measure: Change in total excursion path (mm)
timeFrame: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
measure: Change in velocity of Cop displacement in the anteroposterior directions (mm/s)
timeFrame: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
measure: Change in velocity of Cop displacement in the mediolateral directions (mm/s)
timeFrame: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
measure: Change in the Toronto Alexithymia Scale (TAS-20) score
timeFrame: Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).
Other outcomes:
measure: Number of drop-out
timeFrame: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1)
measure: number of patients who refuse the treatment
timeFrame: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1)
measure: number of falls or event near falling
timeFrame: after the intensive 5-day rehabilitation program (T1)
measure: Score on the Simulation Sickness Questionnaire (SSQ)
timeFrame: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1)
Locations:
city: Verona
country: Italy
facility: Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona
Study officials:
affiliation: Università di Verona
name: Marialuisa Gandolfi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Gandolfi M, Sandri A, Geroin C, Bombieri F, Riello M, Menaspa Z, Bonetto C, Smania N, Tinazzi M. Improvement in motor symptoms, physical fatigue, and self-rated change perception in functional motor disorders: a prospective cohort study of a 12-week telemedicine program. J Neurol. 2022 Nov;269(11):5940-5953. doi: 10.1007/s00415-022-11230-8. Epub 2022 Jul 9.
citation: Gandolfi M, Riello M, Bellamoli V, Bombieri F, Geroin C, Di Vico IA, Tinazzi M. Motor and non-motor outcomes after a rehabilitation program for patients with Functional Motor Disorders: A prospective, observational cohort study. NeuroRehabilitation. 2021;48(3):305-314. doi: 10.3233/NRE-201617.