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Functional Motor DisordersFMDNCT05581134

Immersive Virtual Reality in Functional Motor Disorders

A study testing Virtual Reality intervention in people with Functional Motor Disorders, run by Marialuisa Gandolfi at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Functional Motor Disorders
What is being tested?
Virtual Reality intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteItaly
Study dates
29 Sep 2022to 29 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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 locations and contacts

1 site in 1 country.

Marialuisa Gandolfi, PhD contact

3491656108 ext. +39

marialuisa.gandolfi@univr.it

Italy1 site, 1 recruiting
  • Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona

    Verona, 37131

    Marialuisa Gandolfi, PhD, 3491656108 ext. +39, marialuisa.gandolfi@univr.it

    Michele Tinazzi, PhD, 3480172554 ext. +39, michele.tinazzi@univr.it

    Recruiting

Other trials in Italy

About this study

Official title: 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).

Read the 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.

Being tested
Virtual Reality intervention, Control Group intervention
Keywords
Virtual Reality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality interventionDevice

    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 interventionBehavioural

    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.

Study groups in NCT05581134
Study groupRoleWhat they receive
Virtual Reality GroupExperimentalPatients 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.
Receives: Device: Virtual Reality intervention
Control Group TreatmentActive comparatorPatients 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.
Receives: Behavioral: Control Group intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).

Secondary outcomes (15)
  1. 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).

    Measured: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).

  2. Change in the Brief Pain Inventory (BPI) score

    It evaluates pain intensity (range: 0-40; higher = worse) and interference (range: 0-70; higher = worse).

    Measured: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).

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

    It evaluates depression (range: 0-63; higher = worse).

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

  4. Change in the Beck Anxiety Inventory (BAI) score

    It evaluates anxiety (range: 0-63; higher = worse).

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

  5. 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)

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

  6. 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).

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

  7. Change in gait speed (cm/sec)

    Gait analysis will be used to collect gait speed (cm/s).

    Measured: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).

  8. Change in Swing time (%)

    Gait analysis will be used to collect swing time (%).

    Measured: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).

  9. Change in Stride time (s)

    Gait analysis will be used to collect stride time (s).

    Measured: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).

  10. Change in Stride length (cm)

    Gait analysis will be used to collect stride length (cm).

    Measured: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).

  11. Change in sway area (mm2)

    An electronic monaxial stabilometric platform will be used to collect sway area (mm2).

    Measured: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).

  12. Change in total excursion path (mm)

    An electronic monaxial stabilometric platform will be used to collect total excursion path (mm).

    Measured: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).

  13. 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.

    Measured: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).

  14. 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.

    Measured: Before the intensive 5-day rehabilitation program (T0), after the intensive 5-day rehabilitation program (T1), and after 12 weeks (T2).

  15. Change in the Toronto Alexithymia Scale (TAS-20) score

    It evaluates the level of alexithymia (range: 20-100; higher = worse)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2022
  2. Study start29 Sep 2022
  3. Primary completion30 Aug 2023 (estimated)
  4. Study completion29 Sep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05581134
Sponsor's protocol ID
JP-VR-19
Acronym
FMD
Status last verified
Oct 2022
First submitted
1 Oct 2022
Last updated
14 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 27694498
  • 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.

    PubMed 29364733
  • 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.

    PubMed 28222783
  • 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.

    PubMed 25433033
  • 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.

    PubMed 33722822
  • 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.

    PubMed 35809125
  • 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.

    PubMed 33780378

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality intervention in people with Functional Motor Disorders, run by Marialuisa Gandolfi at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marialuisa Gandolfi, PhD (3491656108 ext. +39, marialuisa.gandolfi@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05581134, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.

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