Immersive Virtual Reality in Functional Motor Disorders (FMD)
October 11, 2022 updated by: Marialuisa Gandolfi
Effectiveness of Immersive Virtual Reality Rehabilitation Program to Reduce Symptoms Severity and Improve Quality of Life in Patients With Functional Motor Disorders
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marialuisa Gandolfi, PhD
- Phone Number: +39 3491656108
- Email: marialuisa.gandolfi@univr.it
Study Contact Backup
- Name: Michele Tinazzi, PhD
- Phone Number: +39 3480172554
- Email: michele.tinazzi@univr.it
Study Locations
-
-
-
Verona, Italy, 37131
- Recruiting
- Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona
-
Contact:
- Marialuisa Gandolfi, PhD
- Phone Number: +39 3491656108
- Email: marialuisa.gandolfi@univr.it
-
Contact:
- Michele Tinazzi, PhD
- Phone Number: +39 3480172554
- Email: michele.tinazzi@univr.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 (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.
|
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score
Time Frame: 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).
|
Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Multidimensional Fatigue Inventory Scale (MFI-20) score
Time Frame: 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).
|
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
Time Frame: 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).
|
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
Time Frame: Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).
|
It evaluates depression (range: 0-63; higher = worse).
|
Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).
|
|
Change in the Beck Anxiety Inventory (BAI) score
Time Frame: Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).
|
It evaluates anxiety (range: 0-63; higher = worse).
|
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
Time Frame: 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)
|
Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).
|
|
Change in the Clinical Global Impression (CGI) score
Time Frame: 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).
|
Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).
|
|
Change in gait speed (cm/sec)
Time Frame: 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).
|
Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
|
|
Change in Swing time (%)
Time Frame: 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 (%).
|
Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
|
|
Change in Stride time (s)
Time Frame: 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).
|
Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
|
|
Change in Stride length (cm)
Time Frame: 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).
|
Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
|
|
Change in sway area (mm2)
Time Frame: 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).
|
Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
|
|
Change in total excursion path (mm)
Time Frame: 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).
|
Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
|
|
Change in velocity of Cop displacement in the anteroposterior directions (mm/s)
Time Frame: 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.
|
Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
|
|
Change in velocity of Cop displacement in the mediolateral directions (mm/s)
Time Frame: 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.
|
Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
|
|
Change in the Toronto Alexithymia Scale (TAS-20) score
Time Frame: Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).
|
It evaluates the level of alexithymia (range: 20-100; higher = worse)
|
Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of drop-out
Time Frame: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1)
|
The number of dropouts before the end of treatment will be collected.
The experimental group will report adverse events on the use of VR.
|
Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1)
|
|
number of patients who refuse the treatment
Time Frame: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1)
|
Recruitment rate
|
Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1)
|
|
number of falls or event near falling
Time Frame: after the intensive 5-day rehabilitation program (T1)
|
Falls or event near falling occurred during the rehabilitation in both groups
|
after the intensive 5-day rehabilitation program (T1)
|
|
Score on the Simulation Sickness Questionnaire (SSQ)
Time Frame: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1)
|
It will be used to evaluate the level of symptoms associated with simulator sickness (subscale range: 0-48; higher=worse)
|
Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marialuisa Gandolfi, PhD, Universita di Verona
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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, Menaspà 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 29, 2022
Primary Completion (Anticipated)
August 30, 2023
Study Completion (Anticipated)
September 29, 2023
Study Registration Dates
First Submitted
October 1, 2022
First Submitted That Met QC Criteria
October 11, 2022
First Posted (Actual)
October 14, 2022
Study Record Updates
Last Update Posted (Actual)
October 14, 2022
Last Update Submitted That Met QC Criteria
October 11, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JP-VR-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.