Immersive Virtual Reality in Functional Motor Disorders
NCT ID: NCT05581134
Last Updated: 2022-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
36 participants
INTERVENTIONAL
2022-09-29
2023-09-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Virtual Reality Group
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.
Virtual Reality intervention
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.
Control Group Treatment
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.
Control Group intervention
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.
Interventions
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Virtual Reality intervention
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.
Control Group intervention
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.
Eligibility Criteria
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Inclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Marialuisa Gandolfi
OTHER
Responsible Party
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Marialuisa Gandolfi
MD, PhD
Principal Investigators
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Marialuisa Gandolfi, PhD
Role: PRINCIPAL_INVESTIGATOR
Università di Verona
Locations
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Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona
Verona, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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JP-VR-19
Identifier Type: -
Identifier Source: org_study_id
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