Clinical trial NCT06274281: Digital Telerehabilitation in Functional Motor Disorders
Official title: Implementing a Digital Telerehabilitation Protocol and Non-motor Outcomes, and Quality of Life in Patients With Functional Motor Disorders: a Feasibility 2-arm Parallel Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Functional Movement Disorder
Keywords: Gait
Wearable devices
Digital telerehabilitation
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 30
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 an experimental 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 (alloca-tion 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, including abnormal gait/balance disorders. Patients experience high degrees of disability and distress, equivalent to those suffering from degenerative neurological diseases. Rehabilitation is essential in their management. 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 and experts in the field. The rehabilitation setting is not adequate for the long-term management and monitoring of these patients. Digital medicine is a new field that means "using digital tools to upgrade the practice of medicine to one that is high-definition and far more individualized." It can upgrade rehabilitation practice, addressing the existing critical components towards marked efficiency and productivity. Digital telerehabilitation will increase the accessibility to personalized rehabilitation by expert professionals placing tools to monitor the patient's health by themselves.

The increasing development and availability of portable and wearable technologies are rapidly expanding the field of technology-based objective measures (TOMs) in neurological disorders. However, substantial challenges remain in (1) recognizing TOMs relevant to patients and clinicians to provide accurate, objective, and real-time assessment of gait and activity in a real-world setting and (2) their integration into telerehabilitation systems towards a digital rehabilitation transition.

This feasibility study provides preliminary data on the integration of a real-time gait and activity analysis by wearable devices in the real world with a digital platform to improve the diagnosis, monitoring, and rehabilitation of patients with FMDs.

Detailed description: Functional movement disorders (FMDs) are part of a wide spectrum of functional neurological disorders characterized by abnormal movements (gait, dystonia, and tremor), which are clinical incongruent with movement disorders caused by neurological disease and are significantly altered by distraction or nonphysiologically manoeuvres. FMDs have an incidence ranging from 4 to 12 per 100.000 population per year and high prevalence (15-20%) in patients accessing neurological clinics. They are a high disabling condition 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 disease, such as Parkinson's Disease. Despite this, FMDs have been widely misunderstood, receiving little public and academic attention.

Diagnostic clinical criteria for FMDs are based on positive signs that support certain integrity of the pathway from an anatomical and physiological perspective: specific maneuvers can make apparent the function that seems to be lost or impaired. Despite the clinical burden, the exact pathophysiological mechanisms underlying FMDs have not been elucidated and so FMDs' management remain largely unknown. The hallmarks of FMDs patients distinguishing them from those with organic movement disorders is that their movements have features usually associated with voluntary movement. Still, patients report them as involuntary and not under their control. Why movements that appear voluntary because altered by distraction are experienced as involuntary (or outside the patient's control) is a matter of debate.

In addition to motor complaints, non-motor symptoms (NMSs) such as fatigue, pain, anxiety, depression have been increasingly recognized as important contributors producing levels of disability over and above those caused by the abnormal movement. Within this perspective should be considered the rehabilitation of patients with FMDs, to reduce disability and improve Health-related Quality of Life (QoL) in the context of a multidisciplinary team. To do that, there are limits that must be overcome: rehabilitation approaches are few and limited because of empirical approaches mainly referring to clinical practice without following evidence-based consensus recommendations, most existing studies are uncontrolled case series or crossover studies and innovations to improve access to specialist rehabilitation treatment by qualified professionals (i.e., tele/remote health an wearable technology) and to monitor patients in the long-term have been seldom explored in patients with FMDs.

Digital medicine, a new field based on "using digital tools to upgrade the practice of medicine to one that is high-definition and far more individualized", led the introduction of 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, enabling site-less, digital clinical trials where suitable participants are identified, consented, and enrolled remotely. The next phase of this will greatly impact clinicians across disciplines including rehabilitation. In fact, in the last few years, telerehabilitation (a telemedicine subfield consisting of a system to control rehabilitation at a distance) has been progressively developed allowing to overcome the barrier of distance and time (mainly in communities far from urban centers), to cut down the cost and labor of accessing healthcare, and to provide access to patients having temporary and permanent disabilities for accurate diagnosis and rehabilitation prescription and delivery.

Digital telerehabilitation combined the advantages of telerehabilitation with the possibility to use digital tools (i.e., wearable sensors, digital platform) in monitoring functions and activities in real-time and in the real-world environment. Digital Telemedicine platforms offer new opportunities for diagnosis, monitoring, treatment, and management of diseases allowing the acquisition, transmission, and storage of clinical information through electronic devices and communication technologies to provide and support remote health care, including rehabilitation. The use of digital technologies applied to rehabilitation through telemedicine systems (telerehabilitation) represents one of the main fronts of development in neurological rehabilitation as it offers the potential to extend specific rehabilitation paths from the hospital phase to the home phase allowing, thanks to the involvement of highly qualified personnel, better management of diseases and their clinical, social and economic outcomes.

The increasing development and availability of portable and wearable technologies are rapidly expanding the field of technology-based objective measures (TOMs) in neurological disorders. However, substantial challenges remain in (1) recognizing TOMs relevant to patients and clinicians to provide accurate, objective, and real-time assessment of gait and activity in a real-world setting and (2) their integration into telerehabilitation systems towards a digital rehabilitation transition. It is crucial in FMDs because of the clinical complexity of patients who require highly qualified personnel, adapting rehabilitation programs over time according to the patients' improvements, and long-term monitoring without impacting health care costs. Besides the pandemic caused by the SARS-CoV-2 virus, which has prevented patients from accessing rehabilitation in hospital settings, the restricted presence of qualified centers for the rehabilitation of patients with FMDs emphasizes the need to create specific digital telerehabilitation pathways by qualified staff that can reach patients who would not have access to such rehabilitative treatment. However, pilot studies for phase III trials - which are comparative randomized trials designed to provide preliminary evidence on the clinical efficacy of a drug or intervention (also commonly known as "feasibility" studies), must be designed to assess the safety of treatment or interventions; to assess recruitment potential; to assess the feasibility of international collaboration or coordination for multicenter trials; to increase clinical experience with the study medication or intervention for the phase III trials . They are the best way to assess feasibility of a large, expensive full-scale study, and in fact are an almost essential pre-requisite.

The primary aim of the study is to implement and assess the feasibility of the steps that need to take place as part of the main confirmatory study on comparing the effects of a digital telerehabilitation program including TOMs on motor symptoms severity and duration in patients with FMDs. The secondary aim is then 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
* acceptance of the diagnosis on the balance of probability
* severity and duration of motor impairment ≥1 scored with the Simplified Functional Movement Disorders Rating Scale (SFMDRS)
* acceptable level of digital skills.

Exclusion Criteria:

* Prominent dissociative seizures
* Mini-Mental State Examination \<23/30
* Patients who continue to express some doubt over the diagnosis.
* prominent cognitive and physical impairment that preclude signing the informed consent for participation in the study.
* Unable or refuse to attend the consecutive 5-day rehabilitation treatment. Patients will give their written informed consent after being informed about the experimental nature of the study. According to the Helsinki Declaration, the study will be carried out, approved by the Local Ethics Committee, and registered at the clinical trial.
* Particularly vulnerable population. The following cannot be included in the study: pregnant women, patients in an emergency.

Primary outcomes:
measure: number of patients who accept/refuse the treatment, physiotherapy compliance and falls or event near falling occurred during rehabilitation
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: Budget issues related to TOMs
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: Time spent to train patients
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 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)
measure: 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: The EuroQol-5D (EQ-5D)
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: iMTA Productivity Cost Questionnaire
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: Gait outcome: Gait speed
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: Gait outcome: Stride length
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: Gait outcome: Cadence
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: Balance outcome: CoP trajectory
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: Balance outcomes: Sway area
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)
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona
city: Verona
country: Italy
facility: USD Parkinson's Disease and Movement Disorders Unit
Study officials:
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