Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06274281
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-01-19
Brief Title:
Digital Telerehabilitation in Functional Motor Disorders
Sponsor:
Universita di Verona
Organization:
Universita di Verona
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Functional motor disorders FMDs are a broad spectrum of functional neurological disorders including abnormal gaitbalance 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 patients 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
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 100000 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 Parkinsons 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 patients 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 ie teleremote 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 ie 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
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 patients 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 ie teleremote 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None