Telemedicine in Functional Motor Disorder

NCT05345340 | Unknown DMC

• 1 other identifier: TeleFMD-BRFVr
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Functional motor disorders (FMDs) are a broad spectrum of functional neurological disorders, referring to abnormal movements like dystonia, tremor, and gait/balance disorders. Patients with FMDs experience high degrees of disability and distress equivalent to those suffering from degenerative neurological diseases. Rehabilitation is essential in managing FMDs. However, the current systems of rehabilitation delivery face two main challenges. Patients are not receiving the amount and kind of evidence-based rehabilitation they need due to the lack of rehabilitation professionals' experts in the field. The rehabilitation setting is not adequate for the long-term management and monitoring of these patients. To date, no randomized controlled trials are evaluating the effectiveness of Telemedicine in the management of patients with FMD. This is a single-blind randomized-controlled trial (RCT) with 2-parallel arms to demonstrate the effectiveness and superiority of a 5-day intensive rehabilitation treatment followed by a telemedicine program on the motor, non-motor symptoms (pain, fatigue, anxiety, and depression), the self-perception of clinical change and Health-Related Quality of Life, and health care costs in patients with FMDs.

Conditions

Functional Movement Disorder

Keywords

Telemedicine; Gait; Economic costs; Pain; Fatigue

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), the day after the intensive 5-day rehabilitation program (T1), after 12 weeks (at the end of the self-management plan, T2), and 24 weeks (follow-up, T3)

Secondary Outcomes (12)

• Change in the Multidimensional Fatigue Inventory Scale (MFI-20) score

  before the intensive 5-day rehabilitation program (T0), the day after the intensive 5-day rehabilitation program (T1), after 12 weeks (at the end of the self-management plan, T2), and 24 weeks (follow-up, T3)

• Change in the Brief Pain Inventory (BPI) score

  before the intensive 5-day rehabilitation program (T0), the day after the intensive 5-day rehabilitation program (T1), after 12 weeks (at the end of the self-management plan, T2), and 24 weeks (follow-up, T3)

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

  before the intensive 5-day rehabilitation program (T0), the day after the intensive 5-day rehabilitation program (T1), after 12 weeks (at the end of the self-management plan, T2), and 24 weeks (follow-up, T3)

• Change in the Beck Anxiety Inventory (BAI) score

  before the intensive 5-day rehabilitation program (T0), the day after the intensive 5-day rehabilitation program (T1), after 12 weeks (at the end of the self-management plan, T2), and 24 weeks (follow-up, T3)

• Change in the 12-item Short-Form Health Survey (SF-12) score

  before the intensive 5-day rehabilitation program (T0), after 12 weeks (at the end of the self-management plan, T2), and 24 weeks (follow-up, T3)

Other Outcomes (2)

• Number of drop-out

  before the intensive 5-day rehabilitation program (T0), the day after the intensive 5-day rehabilitation program (T1), after 12 weeks (at the end of the self-management plan, T2), and 24 weeks (follow-up, T3)

• Number of falls or events near falling.

  before the intensive 5-day rehabilitation program (T0), the day after the intensive 5-day rehabilitation program (T1), after 12 weeks (at the end of the self-management plan, T2), and 24 weeks (follow-up, T3)

Study Arms (2)

Telemedicine Group

EXPERIMENTAL

Patients will receive an individualized intensive 5-day rehabilitation program (2 hours/day, five days/week, one week) by a qualified physiotherapist at the USD Parkinson's Disease and Movement Disorders Unit of Verona (Italy) followed by an individualized self-management program implemented with the Digital Telemedicine platform support ((PHOEMA G.P.I PLATFORM, GPI spa, Trento, Italy). Telemedicine will consist of 24 tele-sessions (1 h/day, one day/week, 24 weeks) and two self-management sessions (1 h/day, two days/week, 24 weeks). For each patient, the duration of the activity, number of steps taken, distance traveled (km), Kcal consumed, duration of inactivity, total hours of sleep, and number of training sessions performed will be monitored through Polar Vantage M devices.

Other: Telemedicine

Control Group

ACTIVE COMPARATOR

Patients will receive the same individualized intensive 5-day rehabilitation program (2 hours/day, 5 days/week, 1 week) of the Telemedicine Group by a qualified physiotherapist at the USD Parkinson's Disease and Movement Disorders Unit of Verona (Italy) followed by a home-based self-management plan (Treatment, as usual, 1 h/day, 3 days/week, 24 weeks) without any Digital Telemedicine platform support.

Other: Usual care

Interventions

Telemedicine OTHER

The 5-day rehabilitation program will consist of exercises to re-establish standard movement patterns within a multidisciplinary etiological framework, according to a validated rehabilitation protocol for FMDs. Treatment will be tailored to the needs of each patient, following general treatment principles in physiotherapy for FMDs. Telemedicine sessions: the patient will perform specific exercises under the supervision of a qualified physiotherapist to provide feedback on the execution and adapt the treatment according to clinical changes/improvements. Polar Vantage M devices will collect the objective measurement after the 5-day rehabilitation program (for five consecutive days), week 12 (for five consecutive days), and week 24 (for five consecutive days).

Telemedicine Group

Usual care OTHER

The 5-day rehabilitation program will be the same as the telemedicine group. A self-management paper log will be given to the patient at the end of the 5-day rehabilitation program. It will include goals, activity plans, and strategies to be used for retraining movements and redirecting attention. Videos stored on the patients' digital device (i.e., tablet, mobile) will include exercises demonstration and execution and strategies to retrain movements. Patients will be encouraged to perform the self-management plan at home on their own (or with their caregivers' help) which will be reported in a paper log and video recorded. The subjective assessment of the patient's motor activity will be collected by clinical diaries focusing on gait and activity level.

Control Group

Eligibility Criteria

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

You may qualify if:

• a clinically definite diagnosis of FMDs based on Gupta and Lang diagnostic criteria with the presence of distractibility maneuvers and a demonstration of positive signs;
• the presence of 1 (isolated FMDs) or more clinical motor symptoms (combined FMDs), including weakness, tremor, jerks, dystonia, gait disorders, and parkinsonism;
• acceptable level of digital skills.

You may not qualify if:

• prominent dissociative seizures
• prominent cognitive and physical impairment that precludes signing the informed consent for participation in the study;
• unable or refuse to attend the consecutive 5-day rehabilitation treatment

Sponsors & Collaborators

• Universita di Verona: lead
• Marialuisa Gandolfi: collaborator

Study Sites (1)

USD Parkinson's Disease and Movement Disorders Unit

Verona, 37134, Italy

RECRUITING

Related Publications (7)

• 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

• Tinazzi M, Morgante F, Marcuzzo E, Erro R, Barone P, Ceravolo R, Mazzucchi S, Pilotto A, Padovani A, Romito LM, Eleopra R, Zappia M, Nicoletti A, Dallocchio C, Arbasino C, Bono F, Pascarella A, Demartini B, Gambini O, Modugno N, Olivola E, Di Stefano V, Albanese A, Ferrazzano G, Tessitore A, Zibetti M, Calandra-Buonaura G, Petracca M, Esposito M, Pisani A, Manganotti P, Stocchi F, Coletti Moja M, Antonini A, Defazio G, Geroin C. Clinical Correlates of Functional Motor Disorders: An Italian Multicenter Study. Mov Disord Clin Pract. 2020 Sep 22;7(8):920-929. doi: 10.1002/mdc3.13077. eCollection 2020 Nov.

  PMID: 33163563 BACKGROUND

• Espay AJ, Aybek S, Carson A, Edwards MJ, Goldstein LH, Hallett M, LaFaver K, LaFrance WC Jr, Lang AE, Nicholson T, Nielsen G, Reuber M, Voon V, Stone J, Morgante F. Current Concepts in Diagnosis and Treatment of Functional Neurological Disorders. JAMA Neurol. 2018 Sep 1;75(9):1132-1141. doi: 10.1001/jamaneurol.2018.1264.

  PMID: 29868890 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

• Gupta A, Lang AE. Psychogenic movement disorders. Curr Opin Neurol. 2009 Aug;22(4):430-6. doi: 10.1097/WCO.0b013e32832dc169.

  PMID: 19542886 BACKGROUND

• 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 BACKGROUND

• Gandolfi M, Landi S, Sandri A, Di Vico IA, Geroin C, Menaspa Z, Maistri G, Fasoli M, Schena F, Tinazzi M, Leardini C. Clinical outcomes and economic impact of a digital telemedicine intervention in patients with functional motor disorders: a single-blind, randomised controlled trial. J Neurol Neurosurg Psychiatry. 2025 Dec 12;97(1):81-90. doi: 10.1136/jnnp-2025-336437.

  PMID: 40912911 DERIVED

MeSH Terms

Conditions

Conversion Disorder; Pain; Fatigue

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Federico Schena, PhD

  Universita di Verona

  STUDY DIRECTOR

Central Study Contacts

Michele Tinazzi, PhD

CONTACT

+390458124285; michele.tinazzi@univr.it

Marialuisa Gandolfi, PhD

CONTACT

+390458124943; marialuisa.gandolfi@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to the type of intervention performed by the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: This is a single-blind randomized-controlled trial (RCT) with 2-parallel arms comparing the effects between the experimental group (EG) and control group (CG). After screening, a simple randomization list will be generated by a physician using an automated randomization system (www.randomization.com) (allocation ratio 1:1) to assign eligible patients to either the EG or the CG. Group allocation will be kept concealed.

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 25, 2022
• Study Start: April 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: March 1, 2024
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)