An interventional study of Digital Telerehabilitation and Usual care in Functional Movement Disorder, sponsored by Universita di Verona. Not yet recruiting at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-23.
Sponsored by Universita di Verona · Not applicable, Interventional, and Treatment
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.
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.
89 studies on the registry are indexed under Conversion Disorder; 34 are open to participants now.
This study's planned enrollment of 30 is below the median of 38 across 51 interventional studies indexed under Conversion Disorder.
Browse Conversion Disorder studies →Universita di Verona is the lead sponsor of 125 studies on the registry; 27 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After the intensive 5-days rehabilitation treatment (2 hours/day, 5 days/week, for 1 week), the EG pa-tients will be encouraged to perform the self-management plan at home with the same duration and in-tensity as the CG (1 hour/session, 3 sessions/week, 12 weeks) through a Digital Telemedicine platform (Phoema GPI Platform, GPI Spa, Trento, Italy). The platform will be implemented with wearable digital devices Axivity AX3, 3-axis Logging Accel-erometer to gather objective and subjective information on the patient's motor activity. At discharge (T1), each patient in the experimental group will receive 2 wearable sensors (Axivity AX3,) for moni-toring of movement data (i.e., activity level, number of steps, distance travelled). The data will be transmitted periodically to the research center and processed. The subjective assessment of the patient's motor activity will be collected by clinical diaries focusing on gait and activity level.
Device: Digital Telerehabilitation
After the intensive 5-days rehabilitation treatment (2 hours/day, 5 days/week, for 1 week), the CG patients will be encouraged to perform the self-management plan at home with the same duration and intensity as the EG (1 hour/session, 3 sessions/week, 12 weeks) without a Digital Telemedicine platform and wearable devices use.
Other: Usual care
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. Wearable devices: each patient in the experimental group will receive 2 wearable sensors (Axivity AX3,) for monitoring of movement data (i.e., activity level, number of steps, distance travelled) during daylife activities and rehabilitation sessions. The subjective assessment of the patient's motor activity will be collected by clinical diaries focusing on gait and activity level.
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.
number of patients who accept/refuse the treatment, physiotherapy compliance and falls or event near falling occurred during rehabilitation
recruitment rate, acceptability of the intervention in terms of number of dropouts before the end of treatment, and safety in terms of reported adverse events during the treatment.
Time frame: 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)
Budget issues related to TOMs
Budget issues in the use of TOMs during the EG intervention
Time frame: 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)
Time spent to train patients
Time to train the patient in using the TOMs
Time frame: 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 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).
Time frame: 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)
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).
Time frame: 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
It evaluates pain intensity (range: 0-40; higher = worse) and interference (range: 0-70; higher = worse).
Time frame: 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
It evaluates depression (range: 0-63; higher = worse).
Time frame: 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
It evaluates anxiety (range: 0-63; higher = worse).
Time frame: 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
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)
Time frame: 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)
The EuroQol-5D (EQ-5D)
It evaluates generic quality of life. The scale ranges from 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine').
Time frame: 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)
iMTA Productivity Cost Questionnaire
It is a Standardized Instrument for Measuring and Valuing Health-Related Productivity Losses. Index score can vary from 0 to 21, with higher scores indicating better quality of life.
Time frame: 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)
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).
Time frame: 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
Gait outcome: Gait speed
They will be evaluated at hospital with Axivity AX3. The outcome for gait will be gait speed (cm/s)
Time frame: 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)
Gait outcome: Stride length
They will be evaluated at hospital with Axivity AX3. The outcome for gait will be stride length (cm).
Time frame: 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)
Gait outcome: Cadence
They will be evaluated at hospital with Axivity AX3. The outcome for gait will be cadence (step/min)
Time frame: 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)
Balance outcome: CoP trajectory
They will be evaluated at hospital stabilometric platform. The outcome for postural control will be the length of the centre of pressure (CoP) trajectory (mm) measured in the eyes open (integrating visual, proprioceptive, and vestibular contributions) and the eyes closed condition (proprioceptive contribution to and the visual dependency on postural control).
Time frame: 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)
Balance outcomes: Sway area
They will be evaluated at hospital stabilometric platform. The outcome for postural control will be the sway area (mm2) measured in the eyes open (integrating visual, proprioceptive, and vestibular contributions) and the eyes closed condition (proprioceptive contribution to and the visual dependency on postural control).
Time frame: 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)
Plan to share: No
Start is estimated for Mar 2024; primary completion for Feb 2025, 11 months later.
Of 34 interventional studies with no phase under Conversion Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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