Digital Telerehabilitation in Functional Motor Disorders
NCT ID: NCT06274281
Last Updated: 2024-02-23
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2024-03-01
2026-02-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental Group Training
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.
Digital Telerehabilitation
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.
Control Group Training
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.
Usual care
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.
Interventions
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Digital Telerehabilitation
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.
Usual care
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Universita di Verona
OTHER
Responsible Party
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Marialuisa Gandolfi
Full Professor
Locations
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Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona
Verona, , Italy
USD Parkinson's Disease and Movement Disorders Unit
Verona, , Italy
Countries
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References
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Other Identifiers
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TOMs_FMD
Identifier Type: -
Identifier Source: org_study_id
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