Clinical trial NCT05345340: Telemedicine in Functional Motor Disorder
Official title: Effectiveness of Telemedicine on Health Outcomes (Clinical, Humanistic, Economic) in the Management of Patients With Functional Motor Disorder: Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Movement Disorder
Keywords: Telemedicine
Gait
Economic costs
Pain
Fatigue
Lead sponsor: Universita di Verona
Sponsor class: OTHER
Collaborators: name: Marialuisa Gandolfi
First posted: 2022-04-25
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Functional movement disorders (FMDs) are part of a broad spectrum of functional neurological disorders characterized by abnormal movements (gait, dystonia, and tremor), which are clinically incongruent with movement disorders caused by neurological disease and are significantly altered distraction or nonphysiologically maneuvers. FMDs have an incidence ranging from 4 to 12 per 100.000 population per year and a high prevalence (15-20%) in patients accessing neurological clinics. They are high disabling conditions characterized by long-term disability, poor quality of life, and economic impact on health and social care systems. Indeed, these patients experience disability and distress equivalent to those suffering from degenerative neurological diseases, such as Parkinson's Disease. Despite this, FMDs have been widely misunderstood, receiving little public and academic attention. Motor deficits, gait and balance disorders, and sensory manifestations are the most frequent symptoms and the leading cause of disability in patients with FMDs. They may occur in an isolated or combined manner, increasing the clinical complexity of these patients. Motor FMDs include functional poverty of movements, weakness, and slowness. Pain and fatigue are invalidating non-motor symptoms (NMSs) associated with FMDs. The pathophysiology of FMDs and their management remain largely unknown. The old assumption of psychological factors as the primary cause (psychogenic illness) has been abandoned due to the lack of evidence about their causal role. They have been removed from the diagnostic criteria described in the DSM-V and are considered risk factors.

Recent research findings suggest three key processes involved in the neurobiology of FMD: abnormal attentional focus, abnormal beliefs/expectations, and abnormalities in the sense of agency. Rehabilitation is essential in managing FMDs to improve function and quality of life in the context of a multidisciplinary team. Of note, patients with functional motor disorder may have much greater potential for recovery than health professionals often consider. However, three unmet needs remain crucial. Firstly, rehabilitation approaches are few and limited because empirical approaches mainly refer to clinical practice without following evidence-based consensus recommendations. Secondly, most existing studies are uncontrolled case series or crossover studies. Finally, adjuncts and innovations to improve access to specialist rehabilitation treatment by qualified professionals (i.e., tele/remote health and wearable technology) and monitor patients in the long-term have seldom been explored in patients with FMDs. The literature shows how these patients generally feel misunderstood and neglected by health professionals, becoming progressively more vulnerable. The connectivity of mobile devices with the internet ushered in technology platforms like telemedicine and wearable sensors, endowing hand-held devices with the ability to acquire and track data on physiologic systems (i.e., cardiovascular, gait) in the ecological setting at home and during the Activities of Daily Living. This introduced a new path for generating a new form of healthcare through the medical data acquisition by the individual, in real-time, in a real-world environment. Telemedicine overcomes the barrier of distance and time and provides access to patients having temporary and permanent disabilities for accurate diagnosis and rehabilitation prescription and delivery. To the best of our knowledge, no studies have been performed on the effectiveness of digital telerehabilitation on motor and non-motor outcomes and quality of life in patients with FMDs. A range of factors supports the implementation of digital telerehabilitation treatments in managing patients with FMDs.

Aims of the project Primary aim: To compare the effects of a telemedicine program on motor symptoms severity and duration in patients with FMDs.

Secondary aim: to compare the training effects on non-motor symptoms (pain, fatigue, anxiety, and depression), the self-perception of clinical change and Health-Related Quality of Life, and health care costs.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in the Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score
timeFrame: 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:
measure: Change in the Multidimensional Fatigue Inventory Scale (MFI-20) score
timeFrame: 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)
measure: Change in the Brief Pain Inventory (BPI) score
timeFrame: 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)
measure: Change in the Beck Depression Inventory (BDI-II) score
timeFrame: 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)
measure: Change in the Beck Anxiety Inventory (BAI) score
timeFrame: 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)
measure: Change in the 12-item Short-Form Health Survey (SF-12) score
timeFrame: 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)
measure: Change in the Clinical Global Impression (CGI) score
timeFrame: 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)
measure: Change in the spatio-temporal gait parameters
timeFrame: 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)
measure: Change in the postural control assessment
timeFrame: 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)
measure: Healthcare Services Volume ad-hoc questionnaire
timeFrame: before the intensive 5-day rehabilitation program (T0), and at 24 weeks (follow-up, T3)
measure: Change in the Toronto Alexithymia Scale (TAS-20) score
timeFrame: 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)
measure: Number of direct Healthcare Costs consumption by an ad-hoc questionnaire
timeFrame: before the intensive 5-day rehabilitation program (T0), and 24 weeks (follow-up, T3)
measure: Number of days off.
timeFrame: before the intensive 5-day rehabilitation program (T0), after 12 weeks (at the end of the self-management plan, T2),and after 24 weeks (follow-up, T3)
Other outcomes:
measure: Number of drop-out
timeFrame: 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)
measure: Number of falls or events near falling.
timeFrame: 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)
Locations:
city: Verona
country: Italy
facility: USD Parkinson's Disease and Movement Disorders Unit
Study officials:
affiliation: Universita di Verona
name: Federico Schena, PhD
role: STUDY_DIRECTOR
References:
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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.
citation: Gupta A, Lang AE. Psychogenic movement disorders. Curr Opin Neurol. 2009 Aug;22(4):430-6. doi: 10.1097/WCO.0b013e32832dc169.
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.