Immersive Virtual Reality in Functional Motor Disorders (FMD)

Marialuisa Gandolfi

Status: Enrolling

Conditions: Functional Motor Disorders

Treatments: Device: Virtual Reality intervention; Behavioral: Control Group intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05581134

JP-VR-19

Details and patient eligibility

About

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).

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Virtual Reality Group

Experimental group

Description:

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.

Treatment:

Device: Virtual Reality intervention

Control Group Treatment

Active Comparator group

Description:

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.

Treatment:

Behavioral: Control Group intervention