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Immersive Virtual Reality in Functional Motor Disorders (FMD)

Primary Purpose

Functional Motor Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Virtual Reality intervention
Control Group intervention
Sponsored by
Marialuisa Gandolfi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Motor Disorders focused on measuring Virtual Reality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Neurosciences, Biomedicine and Movement Sciences, University of VeronaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Reality Group

Control Group Treatment

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change in the Multidimensional Fatigue Inventory Scale (MFI-20) score
It evaluates fatigue differentiating general, physical, reduced-activity, reduced-motivation, and mental fatigue (subscale range: 4-20; higher = worse).
Change in the Brief Pain Inventory (BPI) score
It evaluates pain intensity (range: 0-40; higher = worse) and interference (range: 0-70; higher = worse).
Change in the Beck Depression Inventory (BDI-II) score
It evaluates depression (range: 0-63; higher = worse).
Change in the Beck Anxiety Inventory (BAI) score
It evaluates anxiety (range: 0-63; higher = worse).
Change in the 12-item Short-Form Health Survey (SF-12) score
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)
Change in the Clinical Global Impression (CGI) score
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).
Change in gait speed (cm/sec)
Gait analysis will be used to collect gait speed (cm/s).
Change in Swing time (%)
Gait analysis will be used to collect swing time (%).
Change in Stride time (s)
Gait analysis will be used to collect stride time (s).
Change in Stride length (cm)
Gait analysis will be used to collect stride length (cm).
Change in sway area (mm2)
An electronic monaxial stabilometric platform will be used to collect sway area (mm2).
Change in total excursion path (mm)
An electronic monaxial stabilometric platform will be used to collect total excursion path (mm).
Change in velocity of Cop displacement in the anteroposterior directions (mm/s)
An electronic monaxial stabilometric platform will be used to collect the velocity of Cop displacement in the anteroposterior directions.
Change in velocity of Cop displacement in the mediolateral directions (mm/s)
An electronic monaxial stabilometric platform will be used to collect the velocity of Cop displacement in the mediolateral directions.
Change in the Toronto Alexithymia Scale (TAS-20) score
It evaluates the level of alexithymia (range: 20-100; higher = worse)

Full Information

First Posted
October 1, 2022
Last Updated
October 11, 2022
Sponsor
Marialuisa Gandolfi
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1. Study Identification

Unique Protocol Identification Number
NCT05581134
Brief Title
Immersive Virtual Reality in Functional Motor Disorders
Acronym
FMD
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2022 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
September 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marialuisa Gandolfi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Motor Disorders
Keywords
Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group Treatment
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Virtual Reality intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Group intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score
Description
Objective-rated validated scale to rate the duration and severity of functional motor symptoms (range: 0-54; higher = worse).
Time Frame
Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
Secondary Outcome Measure Information:
Title
Change in the Multidimensional Fatigue Inventory Scale (MFI-20) score
Description
It evaluates fatigue differentiating general, physical, reduced-activity, reduced-motivation, and mental fatigue (subscale range: 4-20; higher = worse).
Time Frame
Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
Title
Change in the Brief Pain Inventory (BPI) score
Description
It evaluates pain intensity (range: 0-40; higher = worse) and interference (range: 0-70; higher = worse).
Time Frame
Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
Title
Change in the Beck Depression Inventory (BDI-II) score
Description
It evaluates depression (range: 0-63; higher = worse).
Time Frame
Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).
Title
Change in the Beck Anxiety Inventory (BAI) score
Description
It evaluates anxiety (range: 0-63; higher = worse).
Time Frame
Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).
Title
Change in the 12-item Short-Form Health Survey (SF-12) score
Description
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)
Time Frame
Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).
Title
Change in the Clinical Global Impression (CGI) score
Description
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).
Time Frame
Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).
Title
Change in gait speed (cm/sec)
Description
Gait analysis will be used to collect gait speed (cm/s).
Time Frame
Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
Title
Change in Swing time (%)
Description
Gait analysis will be used to collect 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).
Title
Change in Stride time (s)
Description
Gait analysis will be used to collect 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).
Title
Change in Stride length (cm)
Description
Gait analysis will be used to collect 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).
Title
Change in sway area (mm2)
Description
An electronic monaxial stabilometric platform will be used to collect 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).
Title
Change in total excursion path (mm)
Description
An electronic monaxial stabilometric platform will be used to collect 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).
Title
Change in velocity of Cop displacement in the anteroposterior directions (mm/s)
Description
An electronic monaxial stabilometric platform will be used to collect the velocity of Cop displacement in the anteroposterior directions.
Time Frame
Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
Title
Change in velocity of Cop displacement in the mediolateral directions (mm/s)
Description
An electronic monaxial stabilometric platform will be used to collect the velocity of Cop displacement in the mediolateral directions.
Time Frame
Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).
Title
Change in the Toronto Alexithymia Scale (TAS-20) score
Description
It evaluates the level of alexithymia (range: 20-100; higher = worse)
Time Frame
Before the intensive 5-day rehabilitation program (T0) and after 12 weeks (T2).
Other Pre-specified Outcome Measures:
Title
Number of drop-out
Description
The number of dropouts before the end of treatment will be collected. The experimental group will report adverse events on the use of VR.
Time Frame
Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1)
Title
number of patients who refuse the treatment
Description
Recruitment rate
Time Frame
Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1)
Title
number of falls or event near falling
Description
Falls or event near falling occurred during the rehabilitation in both groups
Time Frame
after the intensive 5-day rehabilitation program (T1)
Title
Score on the Simulation Sickness Questionnaire (SSQ)
Description
It will be used to evaluate the level of symptoms associated with simulator sickness (subscale range: 0-48; higher=worse)
Time Frame
Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marialuisa Gandolfi, PhD
Phone
3491656108
Ext
+39
Email
marialuisa.gandolfi@univr.it
First Name & Middle Initial & Last Name or Official Title & Degree
Michele Tinazzi, PhD
Phone
3480172554
Ext
+39
Email
michele.tinazzi@univr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marialuisa Gandolfi, PhD
Organizational Affiliation
Università di Verona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona
City
Verona
ZIP/Postal Code
37131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marialuisa Gandolfi, PhD
Phone
3491656108
Ext
+39
Email
marialuisa.gandolfi@univr.it
First Name & Middle Initial & Last Name & Degree
Michele Tinazzi, PhD
Phone
3480172554
Ext
+39
Email
michele.tinazzi@univr.it

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27694498
Citation
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.
Results Reference
background
PubMed Identifier
29364733
Citation
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.
Results Reference
background
PubMed Identifier
28222783
Citation
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.
Results Reference
background
PubMed Identifier
25433033
Citation
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.
Results Reference
background
PubMed Identifier
33722822
Citation
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.
Results Reference
background
PubMed Identifier
35809125
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.
Results Reference
result
PubMed Identifier
33780378
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.
Results Reference
result

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Immersive Virtual Reality in Functional Motor Disorders

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