Immersive Virtual Reality in Functional Motor Disorders

NCT05581134 | Unknown

• 1 other identifier: JP-VR-19
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Functional Motor Disorders

Keywords

Virtual Reality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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).

• 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).

• Change in the Beck Depression Inventory (BDI-II) score

  Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).

• Change in the Beck Anxiety Inventory (BAI) score

  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

  Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).

Other Outcomes (4)

• Number of drop-out

  Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1)

• number of patients who refuse the treatment

  Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1)

• number of falls or event near falling

  after the intensive 5-day rehabilitation program (T1)

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

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

Control Group Treatment

ACTIVE COMPARATOR

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

Interventions

Virtual Reality intervention DEVICE

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.

Virtual Reality Group

Control Group intervention BEHAVIORAL

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.

Control Group Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Marialuisa Gandolfi: lead

Study Sites (1)

Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona

Verona, 37131, Italy

RECRUITING

Related Publications (7)

• Nielsen G, Buszewicz M, Stevenson F, Hunter R, Holt K, Dudziec M, Ricciardi L, Marsden J, Joyce E, Edwards MJ. Randomised feasibility study of physiotherapy for patients with functional motor symptoms. J Neurol Neurosurg Psychiatry. 2017 Jun;88(6):484-490. doi: 10.1136/jnnp-2016-314408. Epub 2016 Sep 30.

  PMID: 27694498 BACKGROUND

• Lubetzky AV, Kary EE, Harel D, Hujsak B, Perlin K. Feasibility and reliability of a virtual reality oculus platform to measure sensory integration for postural control in young adults. Physiother Theory Pract. 2018 Dec;34(12):935-950. doi: 10.1080/09593985.2018.1431344. Epub 2018 Jan 24.

  PMID: 29364733 BACKGROUND

• Kim A, Darakjian N, Finley JM. Walking in fully immersive virtual environments: an evaluation of potential adverse effects in older adults and individuals with Parkinson's disease. J Neuroeng Rehabil. 2017 Feb 21;14(1):16. doi: 10.1186/s12984-017-0225-2.

  PMID: 28222783 BACKGROUND

• Nielsen G, Stone J, Matthews A, Brown M, Sparkes C, Farmer R, Masterton L, Duncan L, Winters A, Daniell L, Lumsden C, Carson A, David AS, Edwards M. Physiotherapy for functional motor disorders: a consensus recommendation. J Neurol Neurosurg Psychiatry. 2015 Oct;86(10):1113-9. doi: 10.1136/jnnp-2014-309255. Epub 2014 Nov 28.

  PMID: 25433033 BACKGROUND

• Perez DL, Edwards MJ, Nielsen G, Kozlowska K, Hallett M, LaFrance WC Jr. Decade of progress in motor functional neurological disorder: continuing the momentum. J Neurol Neurosurg Psychiatry. 2021 Mar 15:jnnp-2020-323953. doi: 10.1136/jnnp-2020-323953. Online ahead of print.

  PMID: 33722822 BACKGROUND

• 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.

  PMID: 35809125 RESULT

• 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.

  PMID: 33780378 RESULT

Study Officials

• Marialuisa Gandolfi, PhD

  Università di Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marialuisa Gandolfi, PhD

CONTACT

3491656108; marialuisa.gandolfi@univr.it

Michele Tinazzi, PhD

CONTACT

3480172554; michele.tinazzi@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An examiner blinded to group allocation will assess all patients. To keep blindness, the examiner will not ask for information about the treatment to the patients or the caregivers, and this last will be instructed not to give any extra information outside of the examiner's questions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 1, 2022
• First Posted: October 14, 2022
• Study Start: September 29, 2022
• Primary Completion: August 30, 2023
• Study Completion: September 29, 2023
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

IT (1)