Telemedicine in Functional Motor Disorder — TeleFMD  

Functional Movement Disorder Clinical Trial

Official title: Effectiveness of Telemedicine on Health Outcomes (Clinical, Humanistic, Economic) in the Management of Patients With Functional Motor Disorder: Randomised Controlled Clinical Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Functional Movement Disorder
• Motor Disorders
• Movement Disorders

• NCT number: NCT05345340
• Study type: Interventional
• Source: Universita di Verona
• Contact: Michele Tinazzi, PhD
• Phone: +390458124285
• Email: michele.tinazzi@univr.it
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Completion date: March 2024